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Malaria Rapid Diagnostic Test Performance

Results of WHO product testing of malaria RDTs: round 6 (2014–2015)

Malaria Rapid Diagnostic Test Performance

Results of WHO product testing of malaria RDTs: round 6 (2014–2015)

I I II I

WHO Library Cataloguing-in-Publication Data:

Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 6 (2014-2015).

I.World Health Organization.

ISBN 978 92 4 151003 5 Subject headings are available from WHO institutional repository

© World Health Organization 2015

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The mention of specific companies or of certain manufacturers’ products does not imply that they are endorsed or recommended by the World Health Organization in preference to others of a similar nature that are not mentioned. Errors and omissions excepted, the names of proprietary products are distinguished by initial capital letters.

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Reference to any company or product in this report, particularly those listed in any of the figures and tables, does not constitute an endorsement, certification, or warranty of fitness by WHO of such company or product for any purpose, and does not imply any preference over companies or products of a similar nature that are not mentioned.

WHO does not furthermore warrant that: (1) the lists and figures are complete and/or error free; and/or that (2) any products included in the figures and tables are of acceptable quality, have obtained regulatory approval in any country, or that their use is otherwise in accordance with the national laws and regulations of any country, including but not limited to patent laws. Inclusion of any products in this report, particularly in any of the figures and tables listed on pages V-VII, does not furthermore imply any approval by WHO of these products (which is the sole prerogative of national authorities).

The WHO Programme of Prequalification of Diagnostics and Medical Devices uses the results of the WHO Malaria RDT Product Testing Programme as the laboratory evaluation component of the prequalification process for malaria RDTs. Although not currently a requirement for WHO procurement, manufacturers are encouraged to apply for WHO prequalification. A regularly updated list of WHO-prequalified diagnostics, including malaria RDTs, is available at http://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/.

WHO recommendations for procurement of malaria RDTs are currently based on the attainment of a set of minimum performance criteria in the WHO Malaria RDT Product Testing Programme. These recommendations were established by the WHO Malaria Policy Advisory Committee in 2012 , are outlined in this report and presented in full in a WHO information note (available at http://www.who.int/malaria/publications/atoz/rdt_selection_criteria_en.pdf?ua=1).Products that do not meet the full set of minimum performance criteria are not eligible for procurement by WHO.

The lists of RDTs included in this report are not exhaustive lists of malaria RDTs. These lists reflect those products which have been submitted for evaluation in Rounds 3-6 of the WHO Malaria RDT Product Testing Programme, and indicate to what extent these products, as manufactured by the listed companies, were -at the time of their evaluation- found to meet the above mentioned set of minimum performance criteria. The evaluation results indicated in the figures and tables apply only to the specific product as listed with its unique product code / catalogue number and as manufactured by the listed company.

The improper storage, transport and handling of malaria RDTs may affect their level of performance.

The fact that certain products are not included in the lists and figures in this report indicates that they have not or not yet been submitted for evaluation in the WHO Malaria RDT Product Testing Programme, or that their evaluation has not yet been completed and published in [a new edition of this report]. It does not however indicate anything in respect of such products’ performance. The lists and figures are updated regularly, and malaria RDTs are added to the lists and figures as and when (following the voluntary participation in the WHO Malaria RDT Product Testing Programme) their evaluation against the above mentioned set of minimum performance criteria has been completed.

Although the malaria RDTs listed in the tables and figures are regularly re-evaluated, and updated evaluation results are published by WHO, WHO cannot represent that products included in the lists and figures will continue to meet the performance criteria in the same manner as indicated. WHO recommends therefore that before procurement of a malaria RDT, each lot of that product undergoes lot testing at one of the two following lot-testing laboratories: Institut Pasteur du Cambodge (IPC), Cambodia or Research Institute for Tropical Medicine (RITM), The Philippines.

WHO disclaims any and all liability and responsibility whatsoever for any injury, death, loss, damage, or other prejudice of any kind that may arise as a result of or in connection with the procurement, distribution and use of any product included in this report and the figures and tables listed on pages V-VII.

This report may not be used by manufacturers and suppliers for commercial or promotional purposes.

http://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en

http://www.who.int/malaria/publications/atoz/rdt_selection_criteria_en.pdf?ua=1

http://www.who.int/malaria/publications/atoz/rdt_selection_criteria_en.pdf?ua=1

I I II I Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 6 (2014–2015)

Contents Acknowledgements IX

AbbrevIAtIons X1. summAry of performAnce of rApId dIAgnostIc tests for mAlArIA: wHo product testIng rounds 1–6 11.1. Introduction 11.2. the wHo product testing programme 11.3. panel detection score and other results of the evaluation 21.4. summary of outcomes 41.5. delisting of products in summary report 41.6. How can product testing results inform rdt procurement and use? 51.7. product testing and wHo programme for prequalification

of diagnostics and medical devices 5

2. eXecutIve summAry 212.1. Introduction 212.2. the wHo product testing programme 212.3. results of the evaluation 222.4. use of the results 23

3. bAckground 244. objectIve 245. mAterIAls And metHods 265.1. test selection 265.2. the product testing protocol 285.3. evaluation panels 285.4. product registration 305.5. specimen panel registration 305.6. test phases 305.7. performing rapid tests 315.8. Interpreting the results 315.9. recording anomalies 32

6. dAtA mAnAgement 327. QuAlIty AssurAnce 327.1. Quality of malaria rdts and their use 327.2. Quality and objectivity of rdt readings 337.3. Quality of wHo specimen bank samples 337.4. Quality of the product testing site 33

8. etHIcAl consIderAtIons 339. dAtA AnAlysIs 339.1. measures of parasite detection: panel detection score

and positivity rates 339.2. false-positive results 34

9.2.1 Incorrect species identification 349.2.2 false-positive results for Plasmodium-negative samples 34

9.3. band intensity 349.4. lot agreement 349.5. Invalid tests 359.6. Heat (thermal) stability 359.7. Anomalies 35

VIV Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 6 (2014–2015)

10. relAtIon between pArAsIte densIty And AntIgen concentrAtIon 3611. lAborAtory versus fIeld-bAsed mAlArIA evAluAtIons of rApId dIAgnostIc tests 3612. results 3712.1. summary 3712.2. phase 1: P. falciparum culture panel 4212.3. phase 2: wild-type P. falciparum and P. vivax

and Plasmodium spp.-negative samples 4312.3.1 P. falciparum detection 4312.3.2 P. vivax detection 4412.3.3 combined detection of P. falciparum and P. vivax 4412.3.4 P. falciparum and P. vivax positivity rate 4512.3.5 band intensity 4512.3.6 false-positive rates 47

12.4. performance of resubmitted products 50

13. HeAt stAbIlIty 5213.1. summary 5213.2. Plasmodium falciparum 5213.3. Plasmodium vivax 52

14. eAse-of-use descrIptIon And AnomAlIes 6014.1. ease of use 6014.2. Anomalies 60

15. dIscussIon of key fIndIngs 6515.1. panel detection score and its relation to sensitivity 6515.2. false-positive rate and specificity 6615.3. reactivity of combination Hrp2 and pan-pldH test lines against

P. falciparum samples 6615.4. Heat (thermal) stability 6715.5. ease-of-use description 6715.6. rdt anomalies in production lots 6815.7. Inter-lot variation 6815.8. target antigens and species 68

16. usIng results to ensure HIgH-QuAlIty dIAgnosIs In tHe fIeld 69

16.1. beyond performance 6916.2. beyond procurement 6916.3. post-market surveillance: lot verification 70

17. conclusIons 7018. references 71AnneXes 73Annex s1: characteristics of evaluation panels used in rounds 1–6 of

wHo malaria rdt product testing, 2008–2015 74Annex s2: malaria rdt field assessment and anomalies 77Annex s3: selection of an appropriate rdt 80Annex 1: characteristics of rdts evaluated in round 6 81Annex 2: malaria rdts: guide to interpretation of results 83Annex 3: phase-1 results 98Annex 4: phase-2 results 102Annex 5: Introducing rdt-based malaria diagnosis

into national programmes 135

VIV Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 6 (2014–2015)

fIgures

Figure S1. Malaria RDT performance in phase 2 of rounds 3–6 against wild-type (clinical) samples containing P. falciparum at low (200) and high (2000 or 5000) parasite density (parasites/µL) and clean-negative samples

Figure S2. Malaria RDT performance in phase 2 of rounds 3–6 against wild-type (clinical) samples containing P. vivax at low (200) and high (2000 or 5000) parasite density (parasites/µL) and clean-negative samples

Figure S3. Panel detection score of malaria combination RDTs meeting WHO procurement criteria for false-positive and invalid rates, in phase 2 of rounds 3–6 against wild-type (clinical) samples containing P. falciparum and P. vivax at low parasite density (200 parasites/µL)

Figure 1. Mode of action of antigen-detecting malaria RDTs

Figure 2. Network of specimen collection, characterization and testing sites

Figure 3. Overview of malaria RDT product testing

Figure 4a. Origin of phase-2 P. falciparum wild-type (clinical) samples

Figure 4b. Origin of phase-2 P. vivax wild-type (clinical) samples

Figure 5. Testing procedure and calculation of panel detection score and band intensity for product A against a sample density of 200 parasites/µL

Figure 6. Testing procedure and calculation of panel detection score and band intensity for product A against a sample density of 2000 parasites/µL

Figure 7. Classification of incorrect species identification with combination malaria RDTs

Figure 8. Explanation of lot agreement calculation

Figure 9. Phase-1 P. falciparum panel detection score of malaria RDTs at low (200) and high (2000) parasite density (parasites/µL)

Figure 10. Phase-2 P. falciparum panel detection score of malaria RDTs at low (200) and high (2000) parasite density (parasites/µL)

Figure 11. Phase-2 P. vivax panel detection score of malaria RDTs at low (200) and high (2000) parasite density (parasites/µL)

Figure 12. Phase-2 P. falciparum panel detection score and positivity rate at 200 parasites/µL

Figure 13. Phase-2 P. vivax panel detection score and positivity rate at 200 parasites/µL

Figure 14. Phase-2 P. falciparum (P. falciparum test line) false-positive rate against clean-negative samples

Figure 15. Phase-2 Plasmodium spp. (pan or P. vivax test line) false-positive rate against clean-negative samples

Figure 16. Phase-2 P. falciparum false-positive rate versus P. falciparum panel detection score at low parasite density (200 parasites/µL)

Figure 17. Phase-2 P. vivax false-positive rate versus P. vivax panel detection score at low parasite density (200 parasites/µL)

Figure 18. Phase-2 P. falciparum panel detection score at low parasite density (200 parasites/µL) during initial and subsequent testing of compulsorily and voluntarily resubmitted malaria RDTs

Figure 19. Phase-2 P. vivax panel detection score at low parasite density (200 parasites/µL) during initial and subsequent testing of compulsorily and voluntarily resubmitted malaria RDTs

Figure 20. Heat stability of P. falciparum-specific test line of P. falciparum-only tests against a low-density P. falciparum sample (200 parasites/µL). Positivity rate at baseline and after 60 days’ incubation

Figure 21. Heat stability of P. falciparum-specific test line of P. falciparum-only tests against a high-density P. falciparum sample (2000 parasites/µL). Positivity rate at baseline and after 60 days’ incubation

Figure 22. Heat stability of P. falciparum-specific test line in combination tests against a low-density P. falciparum sample (200 parasites/µL). Positivity rate at baseline and after 60 days’ incubation

Figure 23. Heat stability of P. falciparum-specific test line in combination tests against a high-density P. falciparum sample (2000 parasites/µL). Positivity rate at baseline and after 60 days’ incubation

Figure 24. Heat stability of pan line of combination tests against a low-density P. falciparum sample (200 parasites/µL). Positivity rate at baseline and after 60 days’ incubation

VIIVI Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 6 (2014–2015)

Figure 25. Heat stability of pan line of combination tests against a high-density P. falciparum sample (2000 parasites/µL). Positivity rate at baseline and after 60 days’ incubation

Figure 26. Heat stability of pan line of combination tests against a low-density P. vivax sample (200 parasites/µL). Positivity rate at baseline and after 60 days’ incubation

Figure 27. Heat stability of pan line of combination tests against a high-density P. vivax sample (2000 parasites/µL). Positivity rate at baseline and after 60 days’ incubation

Figure 28. Heat stability of P. vivax-specific test line in combination tests against a low-density P. vivax sample (200 parasites/µL). Positivity rate at baseline and after 60 days’ incubation

Figure 29. Heat stability of P. vivax-specific test line in combination tests against a high-density P. vivax sample (2000 parasites/µL). Positivity rate at baseline and after 60 days’ incubation

Figure 30. Percentage of RDTs with various anomalies observed in production lots

Figure AS1.1. Box-and-whisker plot of distribution of P. falciparum HRP2 concentration (ng/mL) in product testing phase 2 (wild-type) panels

Figure AS1.2. Box-and-whisker plot of distribution of P. falciparum pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels

Figure AS1.3. Box-and-whisker plot of distribution of P. vivax pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels

Figure AS1.4. Box-and-whisker plot of distribution of P. falciparum aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels

Figure AS1.5. Box-and-whisker plot of distribution of P. vivax aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels

Figure AS2.1. Malaria RDT anomalies encountered in production lots

Figure AS3.1. Selecting an appropriate RDT

Figure A5.1. Example of malaria RDT implementation steps and timeline

Figure A5.2. Components of the budget for a malaria diagnosis programme

tAbles

Table S1. Product resubmissions: WHO malaria RDT product testing rounds 1–6

Table S2. Malaria RDT phase-2 performance in rounds 3–6 against wild-type (clinical) samples containing P. falciparum and P. vivax at low (200) and high (2000 or 5000) parasite density (parasites/µL) and clean-negative samples

Table S3. Malaria RDT rounds 3–6 heat stability results on a cultured P. falciparum sample at low (200) and high (2000) parasite density (parasites/µL). Positivity rate at baseline (room temperature) and after 60 days incubation at room temperature, 35 °C and 45 °C

Table S4. Products evaluated during rounds 1-6 that have been removed from summary results listings

Table 1a. Manufacturers and products accepted into round 6 of WHO malaria RDT product testing programme

Table 1b. Products due for compulsory resubmission in round 6

Table 2. Characteristics of Plasmodium spp.-negative samples

Table 3. Malaria antigen concentrations (ng/mL) in round 6 wild-type, low-density (200 parasites/µL) samples

Table 4. Summary of phase-1 performance of 41 malaria RDTs against 20 cultured P. falciparum lines at low (200) and high (2000) parasite density (parasites/µL)

VIIVI Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 6 (2014–2015)

Table 5. Summary of phase-2 performance of 41 malaria RDTs against wild-type (clinical) P. falciparum and P. vivax samples at low (200) and high (2000) parasite density (parasites/µL) and Plasmodium spp.-negative samples

Table 6a. Heat stability testing results for 41 malaria RDTs on a cultured P. falciparum sample at low (200) and high (2000) parasite density (parasites/µL). Positivity rate at baseline (room temperature) and after 60 days incubation at room temperature, 35 °C and 45 °C

Table 6b. Heat stability testing results for 29 malaria combination RDTs on a wild-type P. vivax sample at low (200) and high (2000) parasite density (parasites/µL). Positivity rate at baseline (room temperature) and after 60 days incubation at room temperature, 35 °C and 45 °C

Table 7. Ease-of-use description of 41 malaria RDTs evaluated in round 6 of WHO malaria RDT product testing

Table 8. Percentage distribution of anomalies observed by product in phase 2

Table AS1.1. Statistics for P. falciparum HRP2 concentration (ng/mL) in product testing phase 2 (wild-type) panels

Table AS1.2. Statistics for P. falciparum pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels

Table AS1.3. Statistics for P. vivax pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels.

Table AS1.4. Statistics for P. falciparum aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels

Table AS1.5. Statistics for P. vivax aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels

Table AS2.1. Field assessment of RDT packaging, safety and ease-of-use to guide product selection

Table A3.1. Lot variation in positive results against phase-1 P. falciparum culture samples at low (200) and high (2000) parasite density (parasites/µL)

Table A3.2. Distribution of test band intensity scores (0–4) against phase-1 P. falciparum cultured parasites at low (200) and high (2000) parasite density (parasites/µL)

Table A4.1. Lot variation in positive results against phase-2 wild-type P. falciparum and P. vivax samples at low (200) and high (2000) parasite density (parasites/µL)

Table A4.2. Distribution of test band intensity (0–4) scores against phase-2 wild-type P. falciparum samples at low (200) and high (2000) parasite density (parasites/µL)

Table A4.3. Distribution of pan/P. vivax test band intensity (0–4) scores for phase-2 wild-type P. vivax samples at low (200) and high (2000) parasite density (parasites/µL)

Table A4.4. Phase-2 P. falciparum test line false-positive rates for wild-type P. vivax samples at low (200) and high (2000) parasite density (parasites/µL)

Table A4.5. Phase-2 pan (or P. vivax) test line false-positive rate for non-P. falciparum infection on phase-2 wild-type P. falciparum samples at low (200) and high (2000) parasite density (parasites/µL)

Table A4.6. Phase-2 false-positive rate for P. falciparum test line results on all malaria-negative samples

Table A4.7. Phase-2 false-positive rate for P. falciparum in samples containing non-malarial infectious pathogens

Table A4.8. Phase-2 false-positive rate for P. falciparum in samples containing potentially cross-reacting blood immu-nological factors

Table A4.9. Phase-2 false-positive rate of pan or P. vivax test line results on all malaria-negative samples

Table A4.10. Heat stability testing results for P. falciparum test line on a P. falciparum sample at low parasite density (200 parasites/µL). Positivity rate at baseline (room temperature) and after 60 days’ incubation at room temperature, 35 °C and 45 °C

Table A4.10a. Heat stability testing results for pan test line of combination RDTs on a P. falciparum sample at low parasite density (200 parasites/µL). Positivity rate at baseline (room temperature) and after 60 days’ incubation at room temperature, 35 °C and 45 °C

Table A4.11. Heat stability testing results for P. falciparum test line on a P. falciparum sample at high parasite density (2000 parasites/µL). Positivity rate at baseline (room temperature) and after 60 days’ incubation at room temperature, 35 °C and 45 °C

Table A4.11a. Heat stability testing results for pan test line of combination RDTs on a P. falciparum sample at high parasite density (2000 parasites/µL). Positivity rate at baseline (room temperature) and after 60 days’ incubation at room temperature, 35 °C and 45 °C

Table A4.12. Heat stability testing results for P. falciparum test line on parasite-negative samples. Positivity rate at baseline (room temperature) and after 60 days’ incubation at room temperature, 35 °C and 45 °C

IXVII I Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 6 (2014–2015)

Table A4.12a. Heat stability testing results for pan or P. vivax test line of combination RDTs on parasite-negative samples. Positivity rate at baseline (room temperature) and after 60 days’ incubation at room temperature, 35 °C and 45 °C

Table A4.13. Heat stability testing results for P. falciparum test line on P. vivax samples at low parasite density (200 parasites/µL). Positivity rate at baseline (room temperature) and after 60 days’ incubation at room temperature, 35°C and 45°C

Table A4:14. Heat stability testing results for P. falciparum test line on P. vivax samples at high parasite density (2000 parasites/µL). Positivity rate at baseline (room temperature) and after 60 days’ incubation at room temperature, 35°C and 45°C

Table A4.15. Heat stability testing results for P. vivax test line on P. falciparum samples at low parasite density (200 parasites/µL). Positivity rate at baseline (room temperature) and after 60 days’ incubation at room temperature, 35°C and 45°C

Table A4.16. Heat stability testing results for P. vivax test line on P. falciparum samples at high parasite density (2000 parasites/µL). Positivity rate at baseline (room temperature) and after 60 days’ incubation at room temperature, 35°C and 45°C

Table A4.17. Heat stability testing results for pan or P. vivax test line of combination tests on a P. vivax sample at low parasite density (200 parasites/ml). Positivity rate at baseline (room temperature) and after 60 days’ incubation at room temperature, 35°C and 45°C

Table A4.18. Heat stability testing results for pan or P. vivax test line of combination tests on a P. vivax sample at high parasite density (2000 parasites/ml). Positivity rate at baseline (room temperature) and after 60 days’ incuba-tion at room temperature, 35°C and 45°C

IXVII I Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 6 (2014–2015)

Acknowledgements

The evaluation reported here was a joint project of the WHO Global Malaria Programme, the Foundation for Innovative New Diagnostics (FIND) and the United States Centers for Disease Control and Prevention (CDC) within the WHO-FIND Malaria RDT Evaluation Programme. The project was financed by FIND through a grant from UNITAID. The project would not have been possible without the cooperation and support of the specimen collection sites and specimen characterization laboratories mentioned, and the authors acknowledge the technical advice from many malaria diagnostic manufacturers and developers. This report of round 6 of WHO malaria RDT product testing was compiled by Jane Cunningham (WHO, Global Malaria Programme, Switzerland), Michelle Gatton (Queensland University of Technology, University of Queensland, Australia) and Sophie Jones (WHO, consultant).

The malaria RDT evaluation programme of WHO and FIND are grateful to all those who contributed to the evaluation and to the preparation of this report:

Salim Abdullah Ifakara Health Research and Development Centre, United Republic of Tanzania

Yong Ah United States Centers for Disease Control and Prevention, National Center for Global Health, Division of Malaria and Parasitic Diseases, United States

Frederic Ariey Institut Pasteur, Cambodia

John Barnwell United States Centers for Disease Control and Prevention, National Center for Global Health, Division of Malaria and Parasitic Diseases, United States

David Bell Foundation for Innovative New Diagnostics, Switzerland1

Andrea Bosman WHO, Global Malaria Programme, Switzerland

Qin Cheng Army Malaria Institute, Australia

Peter Chiodini Hospital for Tropical Diseases, United Kingdom

Jane Cunningham WHO, Global Malaria Programme, Switzerland

Djibrine Djalle Institut Pasteur of Bangui, Central African Republic

Dany Doung Institut Pasteur, Cambodia

Babacar Faye Université Cheikh Anta Diop, Senegal

Dionicia Gamboa Universidad Peruana Cayetano Heredia Instituto de Medicina Tropical, Peru

Michelle Gatton Queensland University of Technology, Australia

Jeffrey Glenn United States Centers for Disease Control and Prevention, National Center for Global Health, Division of Malaria and Parasitic Diseases, United States

Iveth Gonzalez Foundation for Innovative New Diagnostics, Switzerland

Sandra Incardona Foundation for Innovative New Diagnostics, Switzerland

Cara Kosack Médecins sans Frontières, Netherlands

Myat Phone Kyaw Department of Medical Research, Myanmar

Jennifer Luchavez Research Institute of Tropical Medicine, Philippines

Christian Luna Research Institute of Tropical Medicine, Philippines

James McCarthy Queensland Institute of Medical Research, University of Queensland, Australia

Didier Menard Institut Pasteur, Madagascar; Institut Pasteur, Cambodia

Rathana Meth Institut Pasteur, Cambodia

Claribel Murillo Centro Internacional de Entrenamiento e Investigaciones Médicas, Colombia

Sina Nhem Institut Pasteur, National Malaria Centre, Cambodia

Bernhards Ogutu Kenya Medical Research Institute, Kenya

Pamela Onyor Kenya Medical Research Institute, Kenya

1 Currently affiliated with Global Health Technologies Global Good Fund (Intellectual Ventures Lab), United States

1X Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 6 (2014–2015)

Wellington Oyibo University of Lagos, Nigeria

Mark Perkins Foundation for Innovative New Diagnostics, Switzerland

Roxanne Rees-Channer Consultant, Foundation for Innovative New Diagnostics, Hospital for Tropical Diseases, United Kingdom

Muth Sinuon National Malaria Centre, Cambodia

Johanna Beulah Sornillo Research Institute of Tropical Medicine, Philippines

Scott Wilson United States Centers for Disease Control and Prevention, National Center for Global Health, Division of Malaria and Parasitic Diseases, United States

AbbrevIAtIons

CDC United States Centers for Disease Control and Prevention

ELISA enzyme-linked immunosorbent assay

FIND Foundation for Innovative New Diagnostics

HRP2 histidine-rich protein 2

ISO International Organization for Standardization

PCR polymerase chain reaction

PDS panel detection score

pLDH Plasmodium lactate dehydrogenase

RDT rapid diagnostic test (for the purposes of this report, immunochromatographic lateral flow devices for the detection of malaria parasite antigens)

TDR Special Programme for Research and Training in Tropical Diseases sponsored by UNICEF, UNDP, the World Bank and WHO

Sum

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1-6

1X Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)

1. summAry of performAnce of rApId dIAgnostIc tests for mAlArIA: wHo product testIng rounds 1–6

1.1. IntroductionWHO estimates that 3.2 billion people are at risk for malaria. In 2014, there were an estimated 214 million cases (with an uncertainty range of 149 million to 303 million) and an estimated 438 000 deaths (with an uncertainty range of 236 000 to 635 000). Approximately 90% of all malaria deaths occur in sub-Saharan Africa, and nearly 70% occur in children under 5 years. Malaria remains endemic in 97 countries, and, while parasite-based diagnosis is increasing, approximately 35% of suspected malaria cases in Africa were not confirmed with a diagnostic test during 2014, resulting in over-use of antimalarial drugs and poor disease monitoring (1).

WHO recommends that malaria case management be based on parasite diagnosis in all cases (2). The use of antigen-detecting rapid diagnostic tests (RDTs) is a vital part of this strategy, forming the basis for extending access to malaria diagnosis by providing parasite-based diagnosis in areas where good-quality microscopy cannot be maintained. The number of RDTs available and the scale of their use have increased rapidly over the past few years; however, limita-tions of field trials and the heterogeneous nature of malaria transmission have limited the availability of the good-quality data on performance that national malaria programmes require to make informed decisions on procurement and implementation, and it is difficult to extrapolate the results of field trials to different populations and times. Therefore, in 2006, the WHO Special Programme for Research and Training in Tropical Diseases (TDR) and the Foundation for Innovative New Diagnostics (FIND) launched a programme to systematically evaluate and compare the performance of commercially available malaria RDTs.

The results of WHO’s malaria RDT product testing have been published annually since 2009 and form the basis of the procurement criteria of WHO, other United Nations agencies, the Global Fund to Fight AIDS, Tuberculosis and Malaria, national governments and nongovernmental organi-zations. The data have guided procurement decisions, which, in turn, have shifted markets towards better-performing tests (1) and are driving overall improvements in the quality of manufacturing.

RDT sales increased from 46 million sold in 2008 (before implementation of the product testing programme) to 314 million in 2014 (according to manufacturer sales data), when for the second time the number of diagnostic tests provided (RDTs and microscopy combined) exceeded the total number of courses of artemisinin-based combination therapy

(ACT) administered in Africa. In 2014, it was confirmed that all the 97 countries with ongoing malaria transmission had adopted the WHO policy to test before administering treat-ment. Despite these achievements, a large number of cases remain undiagnosed, particularly within the private sector, indicating that there are still some gains to be made (1).

This summary presents an overview of the results of rounds 3–6 of malaria RDT product testing and key concepts for understanding and using the results. It is published in conjunction with the release of the full report on round 6. With the exception of products that are no longer manu-factured and/or are delisted because of failure to comply with compulsory resubmission requirements, the results of all rounds of testing should be considered as a single data set. The separate, full reports of each round (3–7) should be consulted for further details of methods, product performance and interpretation of the results.

1.2. the wHo product testing programmeThe RDT evaluations summarized here were performed in collaboration by WHO, TDR, FIND, the United States Centers for Disease Control and Prevention (CDC) and other partners1. All companies that manufacture RDTs according to the ISO 13485:2003 quality system standard were invited to submit one to three products for evaluation. In each round of testing, products were evaluated against geographically diverse, cryopreserved Plasmodium falciparum and P. vivax clinical samples diluted to 200 and 2000 parasites/µL with consist-ently comparable concentration ranges of histidine-rich protein II (HRP2), Plasmodium lactate dehydrogenase (pLDH) and aldolase determined by quantitative enzyme-linked immunosorbent assay (ELISA) (Annex S1). In the first round of testing, 41 products from 21 manufacturers were evalu-ated against prepared blood panels of cultured P. falciparum parasites, while 29, 50, 48, 42 and 41 products from 13, 23, 27, 34 and 22 manufacturers were evaluated in rounds 2, 3, 4, 5 and 6, respectively. Of these 251 products, 247 progressed to testing against panels of patient-derived P. falciparum and P. vivax parasites and a parasite-negative panel. Thermal stability was assessed after 2 months of storage at elevated temperature and humidity, and a rudimentary assessment of ease of use was made. In round 6, specific observations of RDT anomalies were also systematically recorded. Many manufacturers have decided voluntarily to submit products to

1 See full reports of rounds 1–6 for lists of collaborating partners.

32 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: rounds 1-6 (2008-2015)

one or more rounds of testing, and, in round 5, a requirement was instituted to resubmit products for re-evaluation within 5 years of original testing (Table S1). Of the 247 fully evaluated products in rounds 1–6, 36 have been evaluated twice, 12 have been evaluated three times, two evaluated four times and two evaluated five times. Of the 171 unique products tested in the programme, 45 detect P. falciparum alone, 115 detect and differentiate P. falciparum from non-P. falciparum malaria (either pan-specific or species-specific for P. vivax or P. vivax, ovale and malariae), 10 detect P. falciparum and non-P. falciparum malaria without distinguishing between them, and one product was designed to detect P. vivax only. Manufacturers submitted two lots of each product for evaluation. When the same products (8) were resubmitted in subsequent rounds of testing, the second set of results replaced those from the earlier round. Thus, the performance of some tests in the results below differs from that reported in rounds 1–5.

Of the 19 products due for compulsory retesting in round 6, two were submitted (Table S1). Round 2 products that were not resubmitted have been removed from the figures and tables in this summary performance document.

The aim of the evaluation is to provide comparative data on the performance of the submitted production lots of each product. These data will be used to guide procure-ment decisions by WHO, other United Nations agencies and national governments and constitute the laboratory evaluation component of the WHO prequalification process for malaria RDTs (9). Product testing is part of a continuing programme of work to improve the quality of RDTs in use and to ensure reliable malaria diagnosis in areas where malaria is prevalent. A seventh round of product testing will begin in December 2015. The WHO Global Malaria Programme is currently assessing the impact of making WHO prequali-fication a requirement for procurement, including dossier and manufacture site assessment in addition to laboratory evaluation.

1.3. panel detection score and other results of the evaluationThe results (summarized in Figs S1–S3 and Tables S2 and S3) provide comparative data on two lots of products against a panel of parasite samples diluted in blood to a low density (200 parasites/µL) and a higher density (2000 or 5000 parasites/µL). The former is well below the mean parasite density found in many populations with endemic malaria and is considered close to the threshold that must be detected in order to reliably identify clinical malaria in many settings (10). For the purposes of this report, the main measure of performance is the panel detection score (PDS); for each RDT evaluated, the PDS is measured separately at the lower and the higher parasite densities. The summary figures also show the false-positive rates against blood samples containing no malaria parasites or known markers of other diseases and the rate of invalid results.

The PDS is the percentage of malaria samples in the panel that give a positive result in two RDTs per lot at the lower parasite density or by a single RDT per lot at the higher parasite density. As each sample is tested with RDTs from two lots, for a sample to be positive at the lower parasite density, it must show a positive result in four tests (two RDTs per lot for two lots); at the higher parasite density, it must show a positive result in two tests (one RDT per lot for two lots). Thus, the PDS is a combined measure of positivity rate incorporating inter-test and inter-lot consistency. As all tests performed on each sample must show a positive result for the sample to be considered positive, the PDS for a given RDT will usually be lower than a simple positivity rate per panel, measured by comparing the number of positive tests among all tests performed per panel. The PDS is also different from clinical sensitivity, which is the ability of the test to detect malaria infection in a given population of infected patients. Boxes 1 and 2 illustrate how the PDS is calculated and how it differs from a simple positivity rate for all samples tested and from clinical sensitivity in a population.

The PDS for a given RDT is different from the clinical sensi-tivity of that RDT (also called the true positive rate), which is a measure of the proportion of people known to have the disease who test positive for it. The sensitivity of malaria RDTs is highly dependent on local conditions, including the parasite density in the population; it therefore varies among populations with different levels of transmission, as their level of immunity affects the parasite density at which they exhibit symptoms that warrant a diagnostic test. Where transmission rates are low, the parasite densities in people with symptoms of malaria are likely to be low, and tests will be less sensitive. Test performance at 200 parasites/µL is therefore particularly important. The results in this report show the comparative performance of RDTs and indicate which products are likely to be more sensitive in the field, particularly in populations with low-density infections.

In general, as countries reduce the prevalence of malaria and even move towards malaria elimination, detection of low parasite densities becomes increasingly important in case management. As the high PDS at 2000 parasites/µL indicates, the sensitivity of many of these products is similar in populations with higher parasite densities; therefore, it is not possible to discriminate RDTs with superior performance.

An important caveat to estimating field sensitivity from the PDS provided in this report is that the panels used include only parasites known to express the target antigens. While non-expression of the target antigens has not been recorded for aldolase or pLDH, it is known that parasites that infect people in some areas of South America and India do not express HRP2 (11–12). In areas where HRP2-deleted parasites exist, tests for HRP2 will have greatly reduced sensitivity or be incapable of detecting P. falciparum. In such populations, only tests for pLDH or aldolase in P. falciparum parasites will be effective.

Heat stability (summarized in Table S3) is vital to main-taining the sensitivity of tests in the field. As a result, for

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Box 1: Example calculation of panel detection score and positivity rate for product A against a sample density of 200 parasites/µL

The first reading was at the minimum time specified by the manufacturer; the second reading was up to 30 min latera. A sample is considered detected only if all first test readings, from both lots, are positive, i.e. readings a, b, c and d must be positive.

Product A

c dReading

1Reading

1Reading

2Reading

2

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Test 3 Test 4

a bReading

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1Reading

2Reading

2

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Test 1 Test 2

Detected if 4 positive

first readings

a second reading results are for internal use only

P. falciparum sample a b c d

1 + - + + Sample NOT detected

2 + - - + Sample NOT detected

3 + + + + Sample detected

In this example, only one of three samples was positive all four times it was tested; the PDS is therefore 1/3 = 33%.

The positivity rate is calculated as the percentage of all tests of a particular product that returned a positive test result at the manufacturers’ recommended minimum reading time when tested against a P. falciparum or P. vivax sample.

In the above example, the positivity rate is: 9/12 = 75%.

The positivity rate is always greater than the PDS, except when the PDS and the positivity rate are both 100%.

Box 2: Performance measures in WHO product testing and in field settings: PDS versus clinical sensitivity

WHO Malaria RDT Product TestingPrimary performance measure: PDS indicates which products are likely to be more sensitive in the field, particularly in populations with low‐density infections.

200 parasites/μL

2000 parasites/μL

Reference panels: two fixed parasite densities allows discrimination in RDT performance.

Malaria endemic settingPerformance measure: sensitivity is the proportion of the popu-lation studied who have malaria for whom the test is positive.

- high, moderate, low transmission- immune, non-immune- vulnerable groups

Patients have varying parasite density. Most RDTs for P. falciparum and P. vivax perform well for a parasite density > 2000 parasites/μL, but clinically significant densities < 200 parasites/μL may be missed. The “overall” test performance will nevertheless be classified as very good in a field evaluation.


procurement, careful consideration must be given to ensure that the products to be used in areas with high temperatures of transport and storage have demonstrated stability in the product testing programme. Requirements vary among countries; for example, if tests are to be deployed in areas where temperatures rarely rise above 30 °C, less emphasis is needed on stability at high temperatures than on other aspects of quality.

Ease-of-use requirements depend on the extent of training and the work environment of the users. Particularly in primary health care settings, the simpler the test, the easier it will be to avoid errors in preparation and interpretation. Certain anomalies resulting from defects in production lots or RDT degradation may affect the running of the test or interpretation and may warrant a field safety notice and corrective action.

Detailed results can be found in the report of each evalua-tion (3–7) and at http://www.who.int/malaria/publications/diagnostic_testing/en/.

1.4. summary of outcomesThis laboratory-based evaluation provides a comparative, standardized measure of RDT performance for distinguishing between well and poorly performing tests to serve as a basis for procurement decisions by malaria control programmes and to guide United Nations procurement policy.

In round 6, the proportion of tests that achieved a PDS ≥ 75% at 200 parasites/µL is higher than all previous rounds for both P. falciparum (92.7%) and for P. vivax, (58.6%).

Several RDTs in the six rounds of testing consistently detected malaria at a low parasite density (200 parasites/µL), had low false-positive rates, are stable at tropical temperatures, are relatively easy to use and can detect P. falciparum or P. vivax infections or both.

Although the performance of the products varied widely at low parasite density (200 parasites/µL), all products had a high rate of detection of P. falciparum at 2000 or 5000 parasites/µL, as did the majority of products for P. vivax at 2000 parasites/µL.

All RDTs submitted to round 6 used the HRP2 antigen to detect P. falciparum, and all tests had a falciparum PDS that was < 100%. Three products were submitted that also detected Pf-pLDH. One product combined Pf-pLDH with HRP2 in the same test line, while the other two had dual test lines for detecting P. falciparum: one HPR2 test line and one Pf-pLDH test line. While both of the latter products performed well overall, the Pf-pLDH-detecting lines had considerably poorer performance than the HPR2-detecting test line, with a PDS of 36% and 52%, respectively. Thus, after six rounds of testing, the choice of well-performing pLDH-based P. falciparum tests remains limited, as it does for pan-only-specific tests.

The test performance of lots in round 6 did not vary much (Tables A3.1 and A4.1); in previous rounds, however, large variation has been found, confirming the advisability of

testing lots after purchase and before use in the field. Anomalies that can interfere with test interpretation were recorded regularly during round 6, each product had between one and six different types of anomaly (Annex S2, Table 8, Fig. 30). The frequency of anomalies was recorded for the first time in round 6. Incomplete clearing and red background were the most common anomalies, seen in 95% and 85% of products, respectively. Cases of failed migration, incomplete migration and patchy broken test lines were the anomalies seen next most regularly, in 34%, 32% and 37% of products, respectively. Most products (29/41) had anomalies in < 5% of the tests; nine products had anomalies in 5–10% of tests and three had anomalies in 16–98% of all tests (Table 8).

All the RDTs evaluated in round 6 were in cassette format.

Only two of the 19 RDTs due for compulsory resubmission were retested, and both met the WHO procurement criteria on initial and repeat testing; however, both products had diminished performance on re-testing, with a decrease in PDS of 7% and 4% against P. falciparum. The combination RDT product showed a comparable PDS against P. vivax to that obtained at initial testing. Both products showed decreases of 3.0% and 1.6% in false-positive rates on re-testing.

1.5. delisting of products in summary reportManufacturers who choose not to submit products due for compulsory resubmission (every 5 years) are removed from the summary results listing (Tables S2 and S3) and the online interactive database (13) and are featured only in the full round-specific product testing report. They are also not eligible for WHO procurement. Furthermore, a product is delisted if WHO is notified by the manufacturer that its production has been discontinued. To date, 51 products have been delisted (Table S4).

1.6. How can product testing results inform rdt procurement and use?Accurate diagnosis is vital to good malaria case manage-ment, whether based on microscopy or RDTs. The results of this report should be used to make a short list of RDTs for procurement for use in settings where good microscopy is not available or appropriate. Box 3 lists WHO’s minimum criteria for RDT selection, and Annex S3 provides a step-by-step approach to selecting an RDT, taking into consideration local malaria transmission and illness where the tests will be used (e.g. Plasmodium spp., target antigen, parasite densities, climate) and other important considerations, including ease of use in the field (Annex S2), training or retraining require-ments and lot testing1.

The results in Table S2 indicate WHO prequalification status and are colour-coded to reflect achievement of WHO

1 The WHO-FIND malaria RDT evaluation programme provides lot-testing capacity in two regional laboratories free of charge; it can be accessed at [email protected] and [email protected].

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performance requirements for RDT procurement. A web-based tool that allows filtering of product testing results by various parameters to assist in selecting products with the performance characteristics most suitable for a country’s health programme is available and maintained by FIND (13). This online database has been updated to allow filtering of results by RDT procedural characteristics, such as blood volume requirements, number of buffer drops and time to a result. This will allow identification of products with similar procedures so that, when product replacement is required, another product can be selected with the same or a similar protocol. Use of similar products may reduce the need for user retraining and reduce user error.

Comprehensive guidance on several aspects of procurement can be found in Good practices for selecting and procuring rapid diagnostic tests for malaria (14) and guidance on implementation in Universal access to malaria diagnosis (15).

1.7. product testing and wHo programme for prequalification of diagnostics and medical devicesIn the WHO programme for prequalification of diagnostics and medical devices, the results of product testing are used as the laboratory evaluation component of the prequalification process for malaria RDTs. These data are used to set priorities for dossier review and inspection. Although prequalification is not currently a requirement for WHO procurement, manu-facturers are encouraged to apply for it, as it may become a requirement for WHO procurement in the future. Prequalified RDTs are listed in summary tables and at http://www.who.int/diagnostics_laboratory/evaluations/PQ_list/en/.

Box 3: WHO selection criteria for the procurement of RDTs

Products should be selected in line with the following set of criteria, based on the results of the assessment of the WHO Malaria RDT Product Testing Programme:

(A) For the detection of Plasmodium falciparum (Pf) in all transmission settings the panel detection score (PDS) against Pf samples should be at least 75% at 200 parasites/µL.

(B) For the detection of Plasmodium vivax (Pv) in all transmission settings the panel detection score (PDS) against Pv samples should be at least 75% at 200 parasites/µL.

(C) The false positive rate should be less than 10%.

(D) The invalid rate should be less than 5%.

Only products meeting performance criteria outlined in A,B,C and D are recommended for procurement


Figure S1: Malaria RDT performance in phase 2 of rounds 3-6 against wild-type (clinical) samples containing P. falciparum at low (200) and high (2000 or 5000) parasite density (parasites/μL) and clean-negative samples

a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive. b Clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality. * Indicates tests that also detect other non-P. falciparum parasites

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Figure S1: Malaria RDT performance in phase 2 of rounds 3-6 against wild-type (clinical) samples containing P. falciparum at low (200) and high (2000 or 5000) parasite density (parasites/μL) and clean-negative samples

a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive. b Clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality. * Indicates tests that also detect other non-P. falciparum parasites

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200 parasites/µL (HRP2)200 parasites/µL (non-HRP2)2000 parasites/µL (HRP2)2000 parasites/µL (non-HRP2)False-positive Plasmodium spp. rate (%)Invalid rate (%)


Figure S2: Malaria RDT performance in phase 2 of rounds 3-6 against wild-type (clinical) samples containing P. vivax at low (200) and high (2000 or 5000) parasite density (parasites/μL) and clean-negative samples

a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive. b Clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality.

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Figure S2: Malaria RDT performance in phase 2 of rounds 3-6 against wild-type (clinical) samples containing P. vivax at low (200) and high (2000 or 5000) parasite density (parasites/μL) and clean-negative samples

a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive. b Clean-negative - blood samples from healthy volunteers with no known current illness or blood abnormality.

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Figure S3: Panel detection score of malaria combination RDTs meeting WHO procurement criteria for false-positive and invalid rates, in phase 2 of rounds 3–6 against wild-type (clinical) samples containing P. falciparum and P. vivax at low parasite density (200 parasites/µL)

100

80

60

40

20

00 20 40 60 80 100

Panel detection score P. falciparuma

Pan

el d

etec

tion

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re P

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90

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80

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00 20 40 60


Pan

el d

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tion

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re P

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1 Core™ Malaria Pv/Pf MAL-1900222 diagnosticks MALARIA (Pan/Pf) Cassette MPNFWBC1007.43 Malaria pf (HRP II) / (PAN-pLDH) Antigen Detection Test Device MFV-124R4 SD BIOLINE Malaria Ag P.f/Pan 05FK60/05FK635 diagnosticks MALARIA (Pan/Pv/Pf) Cassette MPNVFC1007.56 ICT Malaria Dual Test ML037 NanoSign Malaria Pf/Pan Ag 3.0 RMAP108 BIONOTE MALARIA P.f.& P.v. Ag Rapid Test Kit RG19-129 RAPID 1-2-3® HEMA CASSETTE MALARIA PF/PV TEST MAL-PFV-CAS/25(100)10 Core™ Malaria Pan/Pv/Pf MAL-19002611 SD Bioline Malaria Ag P.f/P.v 05FK8012 BioTracer™ Malaria P.f/P.v Rapid Card 1741213 RapiGEN BIOCREDIT Malaria Ag Pf/Pv (HRPII/pLDH) C40RHA2514 KHB® Malaria Ag P.f/P.v Rapid Test KH-R-07-5015 CareStart™ Malaria HRP2/pLDH (Pf/Pv) COMBO G0161/G0161-ET17 SD BIOLINE Malaria Ag Pf/ Pan 05FK6618 CareStart™ Malaria HRP2/pLDH (Pf/PAN) COMBO G0131/G0131-ET19 DIAQUICK Malaria P.f/Pan Cassette Z11200CE20 Malaria PV/PF (pLDH/HRP2) Antigen Test Inf-7221 ATOMORAPID™ MALARIA (PF/PAN) MMAL0122 CareStart™ Malaria HRP2/pLDH (Pf/VOM) COMBO G0171/G0171-ET23 Humasis Malaria P.f/Pan Antigen Test AMAL-702524 HiSens Malaria Ag P.f/P.v Combo Card HR312325 HiSens Malaria Ag P.f/VOM Combo Card HR332326 Malaria Pf/Pan One Step Rapid Test RT 2022227 RapiGEN BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C30RHA2528 Humasis Malaria P.f/Pan Antigen Test ANMAL-702529 CareStart™ Malaria pLDH 3 Line Test G012130 Humasis Malaria P.f/P.v Antigen Test ANMIV-702531 Is It… Malaria Pf/Pv Device AL03032 Advanced™ Quality Rapid Malaria Test (Pf/Pan) ITP1100533 FirstSign™ - ParaView (Pan+Pf) Malaria Test 2101CB-2534 CareStart™ Malaria Screen G023135 Vikia® Malaria Ag Pf/Pan 41249936 ABON™ Plus Malaria P.f/Pan Rapid Test Device (Whole Blood) IMA-T40237 SD Bioline Malaria Ag P.f/P.f/P.v 05FK12038 First Response® Malaria pLDH/HRP2 Combo Test I16FRC39 Malaria Pf (HRPII) PV (PLDH) Antigen Detection Test Device GM00640 First Response® Malaria Ag Pf/Pv Card Test PI19FRC41 ParaHIT - Total Ver. 1.0 (Device) 55IC204-10

42 Advantage Malaria Pan + Pf Card IR23102543 CareStart™ Malaria pLDH (PAN) G011144 Maleriscan® Malaria P.f/PAN (Pv, Pm, Po) 3 Line Antigen Test MAT-PF/PAN-5045 GenBody™ Malaria Pf/Pan Ag MALAG10046 CareStart™ Malaria/Pregnancy Combo (pLDH/HRP2/HCG) G022147 BioTracer™ Malaria P.f/PAN Rapid Card 1701248 BIONOTE MALARIA P.f & Pan Ag Rapid Test Kit RG19-0849 First Response® Malaria Ag. pLDH/HRP2 Combo Card Test PI16FRC50 Malascan™ Device - Rapid test for Malaria Pf/Pan 5040202551 ASAN Easy Test® Malaria Pf/Pan Ag AM4650-K52 Falcivax™ Rapid Test for Malaria Pv/Pf 50301002553 Malaria pf (HRP II) / pv (pLDH) Antigen Detection Test Device MFV-124V54 Parascreen® - Rapid Test for Malaria Pan/Pf 50303002555 QuickProfile™ Malaria Pf/Pan Test 7106356 EzDx™ Malaria Pan/Pf Rapid test detection Kit RF MAL 00157 Coretests® One Step Malaria Pf/Pv Ag Test Device B42-21/B42-2258 QuickProfile™ Malaria Pf/Pv Test 7105059 One Step Malaria P.f/P.v Whole Blood Test W056-C60 OnSite Malaria Pf/Pan Ag Rapid Test R0113C61 Meriscreen Malaria Pf/Pan Ag MHLRPD-0162 One Step Malaria P.f/Pan Whole Blood Test W62-C63 ParaHIT - Total Ver. 1.0 (Dipstick) 55IC203-1064 EzDx™ Malaria Pv/Pf Rapid Malaria antigen detection test RK MAL 00365 Meriscreen Malaria Pf/Pv Ag MFLRPD-0166 IMMUNOQUICK CONTACT MALARIA +4 0525K2567 Advanced Quality™ One Step Malaria (Pf/Pv) Tri-line Test (whole blood) ITP11003 TC4068 OnSite Malaria Pf/Pv Ag Rapid Test R0112C69 MeDiPro Malaria Ag HRP2/pLDH Combo IR-0051K70 ACCUCARE ONE STEP MALARIA Pf/Pan Antigen Test MAGC 2571 Malaria pf (HRP II)/PAN (pLDH) Antigen Detection Test Device 1-13-101-172 ParaHIT®fV Rapid test for P. falciparum and P. vivax Malaria - Device 55IC402-5073 AZOG Malaria pf (HRPII)/pf (LDH)/ (PAN-LDH) Antigen Detection Device MFV-124F74 AZOG hCG Malaria Detection Test Device MPT-12475 Malaria Pf./Pan Antigen (MAL Pf/Pan) Test Kit A03-18-32276 Malaria pf (HRP II) / pv (pLDH) Antigen Detection Test Device 1-13-101-377 Malaria Pf/Pv GM00278 Malaria Pf/ PAN GM00479 One Step Malaria P.f/Pan Test W56-C80 Advantage Mal Card IR22102581 Humasis Malaria P.f/P.v Antigen Test AMFV-7025

a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive.

Sum

ma

ry

ro

un

dS

1-6


Table S1: Product resubmissions: WHO malaria RDT product testing rounds 1—6

Manufacturer Product name Product code

Product re-submission

Round

Voluntary Compulsory

Access Bio, Inc.

CareStart™ Malaria HRP2/pLDH (Pf/Pv) COMBO G0161/G0161-ET 2, 4CareStart™ Malaria HRP2/pLDH (Pf/VOM) COMBO G0171/G0171-ET 2, 4CareStart™Malaria HRP2 (Pf) G0141/G0141-ET 1 5CareStart™ Malaria HRP2/pLDH (Pf/PAN) Combo G0131/G0131-ET 1 5CareStart™Malaria pLDH (PAN) G0111 1 5CareStart™Malaria HRP2/pLDH (Pf) G0181/G0181-ET 2 6

Advy Chemical Pvt. Ltd. (Affiliate of Bharat Serums & Vaccines Ltd. ) EzDx™ Malaria Pan/Pf Rapid Test Detection Kit RK MAL 001 4, 5, 6

ARKRAY Healthcare Pvt. Ltd.aParaHIT® - f (Device)b 55IC102-10 1, 3ParaHIT® - f (Dipstick)c 55IC101-10 1, 3

AZOGMalaria pf (HRP II) / (PAN-LDH) Antigen Detection Test Deviced MFV-124R 1, 3Malaria pf (pLDH) / PAN-pLDH Test Device MFV-124 3, 5

Bhat Bio-Tech India (P) Ltd. Maleriscan® Malaria Pf/PAN (Pv, Pm, Po) 3 Line Antigen Test MAT-PF/PAN-50 4, 5Bioland NanoSign Malaria Pf/Pan Ag RMAP10 3, 4

Bionote, Inc.BIONOTE MALARIA P.f. Ag Rapid Test Kit RG19-11 3, 6BIONOTE MALARIA P.f & Pan Ag Rapid Test Kit RG19-08 3, 6

Biosynex IMMUNOQUICK® MALARIA falciparum 0502_K25 1 5Bio Focus Co., Ltd. BioTracer™ Malaria P.f/PAN Rapid Card 17012 5, 6

Blue Cross Bio-Medical (Beijing) Co., Ltd.One Step Malaria Pf Test (cassette) 522352 2, 3, 4One Step Malaria P.F/P.V Test (Cassette) 523352 4, 5

CTK Biotech, Inc.Onsite Pf Ag Rapid Test R0114C 2, 3, 6Onsite Malaria Pf/Pan Malaria Ag Rapid Test R0113C 2, 3, 4, 5, 6Onsite Malaria Pf/Pv Ag Rapid Test R0112C 2, 3, 4, 6

DiaMed - A Division of Bio-Rad OptiMAL-IT 710024 1, 3

Guangzhou Wondfo Biotech Co. Ltd.Wondfo One Step Malaria Pf/Pan Whole Blood Test W56-C 1, 3One Step Malaria P.f/P.v Whole Blood Test W056-C 5, 6One Step Malaria P.f Teste W37-C 2, 3, 4, 6

Humasis Co., Ltd. Humasis Malaria Pf/Pan Antigen Test AMAL-7025 4, 5

ICT INTERNATIONALICT Malaria Combo Cassette Test ML02 1, 3, 4ICT Malaria Pf Cassette Test ML01 1, 3ICT Malaria Dual Test ML03 3, 5

InTec Products, Inc.Advanced Quality™ One Step Malaria Pf Test ITP11002TC1/TC40 1, 3 5Advanced Quality™ One Step Malaria (Pf/Pv) Tri-line Test (whole blood) ITP11003 TC40 3, 6

J.Mitra & Co. Pvt. Ltd.Advantage Pan Malaria Card IR013025 1 5Advantage Mal Card IR221025 1 5Advantage P.f Malaria Card IR016025 1 5

Orchid Biomedical SystemsParacheck® Pf Device - Rapid test for P. falciparum Malaria (Ver. 3)f 30301025 1, 3, 4Paracheck® Pf Dipstick - Rapid test for P. falciparum Malaria (Ver.3)f 30302025 1, 3, 4

Premier Medical Corporation Ltd. First Response® Malaria Ag Combo (pLDH/HRP2)g I16FRC25 1, 2, 5First Response® Malaria Ag P. falciparum (HRP2) Card Test I13FRC25 1 5

RapiGEN Inc. RapiGEN BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) C30RHA25 5, 6SSA Diagnostics & Biotech Systems diagnosticks- Malaria (Pf)Cassette WB KMFC6001 2, 5

Standard Diagnostics Inc.

SD BIOLINE Malaria Ag 05FK40 1, 3SD BIOLINE Malaria Ag Pf/Pan 05FK60 1, 3, 5SD BIOLINE Malaria Antigen 05FK50 1 5SD Bioline Malaria Ag P.f (HRP2/pLDH) 05FK90 3, 6SD Bioline Malaria Ag P.f/P.v 05FK80 2 6

Unimed International Inc. FirstSign™ - ParaView (Pan+Pf) Malaria Test 2101 CB-25 2, 4

Vision Biotech (Pty) Ltd / Orgenics (Alere Healthcare (Pty) Ltd subsidaries)

Malaria Rapid Combo/Clearview® Malaria Combo VB11h 1, 3Malaria Rapid Pf /Clearview® Malaria Pf VB01 1, 3, 5Malaria Rapid Dual/Clearview® Malaria Dual Test Device VB20h 1, 3, 5

Zephyr Biomedical Systems

Malascan™ Device - Rapid test for Malaria Pf/Pan 50402025 1, 3Parabank™ Device - Rapid test Malaria Pan 50301025 1, 3

Parascreen™ Device - Rapid test for Malaria Pan/Pf 50310025; 503030025 (rd 6) 1, 3, 4, 5, 6

Falcivax™ Rapid Test for Malaria Pv/Pf (device) 50300025; 503010025 (rd 6) 2, 4, 6

a Span Diagnostics Ltd. is now ARKRAY Healthcare Pvt.Ltd. b In round 1 product name and catalogue number was Parahit-f TEST DEVICE FOR FALCIPARUM MALARIA (25975)c In round 1 product name and catalogue number was Parahit-f DIPSTICK FOR FALCIPARUM MALARIA (25977)d Round 1 product name error : published - Malaria Pf (HRPII)/pv-LDH) Antigen Detection Test Device Code; corrected product name: Malaria Pf (HRPII/PAN-LDH) Antigen

Detection Test Device Code. No change in product code.e In round 2, product did not pass phase 1, therefore results do not feature in summary tables. f Ver.3 was introduced after round 1g Error in WHO Malaria RDT product testing: round 1 report: product code (II6FRC30) should have been ( I16FRC ), as in round 2h New company acquisition (Alere™), therefore change in product branding and catalogue numbers; VB011 to VB11 and VB020 to VB20. Manufacturer confirmed

compliance with product definition.


Tabl

e S2

: Mal

aria

RDT

pha

se-2

per

form

ance

in r

ound

s 3–

6 ag

ains

t w

ild-t

ype

(clin

ical

) sa

mpl

es c

onta

inin

g P.

falc

ipar

um (

Pf)

and

P. v

ivax

(Pv

) at

low

(200

)

and

high

(200

0 or

500

0) p

aras

ite

dens

ity

(par

asit

es/μ

L) a

nd c

lean

-neg

ativ

e sa

mpl

es

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Pane

l det

ectio

n sc

orea

False

-pos

itive

rat

es (%

)To

tal f

alse

-pos

itive

ra

tesb

(%)

Inva

lid

rate

(%

)lRo

und

Mee

ts

WH

O

proc

urem

ent

crite

ria

200

pa

rasit

es/μ

L20

00 o

r 50

00

para

sites

/μL

200

pa

rasit

es/μ

L20

00 o

r 50

00

para

sites

/μL

Clea

n-ne

gativ

e sa

mpl

es

Pf samplesc

Pv samplesd

Pf samplesc

Pv samplesd

Pf s

ampl

esPv

sam

ples

Pf s

ampl

esPv

sam

ples

False

-po

sitiv

e

non-

Pf

infe

ctio

ne

False

-po

sitiv

e

Pf

infe

ctio

nf

False

-po

sitiv

e

non-

Pf

infe

ctio

ng

False

-po

sitiv

e

Pf

infe

ctio

nh

False

-pos

itive

Pl

asm

odiu

m sp

p.

Infe

ctio

ni

Pf o

nly

ABON

™ M

alar

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apid

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(Who

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gzho

u) C

o. L

td32

.7N

A99

.0N

AN

A0

NA

0.0

0.4

0.0

4N

oAd

vanc

ed Q

ualit

y™ O

ne S

tep

Mal

aria

Pf T

est

ITP11

002T

C1/TC

40In

Tec

Prod

ucts

, Inc

.53

.0N

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.0N

AN

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6N

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77.

7 (2

33)

0.4

5N

oAd

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age

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aria

Car

dIR

0160

25J.

Mitr

a &

Co.

Pvt

. Ltd

.89

.0N

A99

.0N

AN

A0.

7N

A0.

00.

00.

05

Yes

BION

OTE

MAL

ARIA

P.f.

Ag

Rapi

d Te

st K

itjRG

19-1

1Bi

onot

e,In

c.88

.0N

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0.0

NA

NA

0.0

NA

0.0

0.5

0.0

6Ye

sCa

reSt

art™

Mal

aria

HRP

2 (P

f)G0

141m

/G01

41-E

TAc

cess

Bio

, Inc

.91

.0N

A10

0.0

NA

NA

0.0

NA

0.0

0.9

0.0

5Ye

sm

Care

Star

t™ M

alar

ia H

RP2/

pLDH

Pf t

estj

G018

1m/G

0181

-ET

Acce

ss B

io, I

nc.

91.0

NA

99.0

NA

NA

0.7

NA

0.0

0.0

0.0

6Ye

sm

Core

™ M

alar

ia P

f M

AL-1

9002

0Co

re D

iagn

ostic

s97

.0N

A10

0.0

NA

NA

0.0

NA

0.0

1.0

(198

)0.

33

Yes

EzDx

™ M

alar

ia P

f Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

08Ad

vy C

hem

ical

Priv

ate

Lim

ited

71.0

NA

100.

0N

AN

A1.

4N

A1.

41.

00.

16

No

Firs

t Res

pons

e® M

alar

ia A

g P.

falc

ipar

um (H

RP2)

Car

d Te

stI1

3FRC

25Pr

emie

r Med

ical

Cor

pora

tion

Ltd.

95.0

NA

100.

0N

AN

A0.

7N

A0.

00.

40.

05

Yesm

Firs

t Res

pons

e® M

alar

ia A

g P.

falc

ipar

um (H

RP2)

Car

d Te

stPI

13FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

91.0

NA

100.

0N

AN

A0.

0N

A0.

01.

00.

06

Yes

Firs

tSig

n™ M

alar

ia P

f21

00CB

-25

Uni

med

Inte

rnat

iona

l Inc

.94

.9N

A10

0.0

NA

NA

0.7

NA

1.5

2.2

(231

)0.

24

Yes

Hum

asis

Mal

aria

P.f

Antig

en T

est

ANM

PF-7

025

Hum

asis

Co.

, Ltd

.87

.0N

A10

0.0

NA

NA

1.4

NA

1.4

1.4

0.0

6Ye

sIC

T Di

agno

stic

s M

alar

ia P

.f.M

L01

ICT

INTE

RNAT

ION

AL86

.9N

A98

.0N

AN

A0.

0N

A0.

00.

00.

03

Yes

IMM

UN

OQU

ICK

CON

TACT

falc

ipar

um

0519

K25

Bios

ynex

81.8

NA

100.

0N

AN

A3.

6 (1

39)

NA

1.4

4.0

(199

)0.

33

Yes

IMM

UN

OQU

ICK®

MAL

ARIA

falc

ipar

um05

02_K

25Bi

osyn

ex72

.0N

A93

.0N

AN

A3.

6N

A4.

35.

1 (2

34)

0.2

5N

oKH

B® M

alar

ia A

g P.

f Rap

id T

est

KH-R

-06-

20

Shan

ghai

Keh

ua B

io-e

ngin

eerin

g Co

.,Ltd

.79

.0N

A91

.8 (9

8)N

AN

A11

.4N

A12

.910

.6 (2

35)

0.7

5N

oM

alar

ia A

ntig

en T

est-

PfM

AG01

040

Osca

r Med

icar

e Pv

t. Lt

d.91

.0N

A10

0.0

NA

NA

1.4

NA

1.4

1.0

0.0

6Ye

sM

aler

isca

n ®

Mal

aria

P.f

Antig

en T

est

MAT

-PF-

50Bh

at B

io-T

ech

Indi

a (P

te.)

Ltd.

83.7

NA

98.0

NA

NA

1.5

NA

0.0

0.4

0.2

4Ye

sN

anoS

ign

Mal

aria

Pf A

g RM

AF10

Biol

and,

Ltd

84.9

NA

100.

0N

AN

A0.

0N

A0.

00.

00.

33

Yes

One

Step

Mal

aria

P.f

Who

le b

lood

Tes

tjW

37-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.85

.0N

A99

.0N

AN

A0.

0N

A0.

00.

00.

06

Yes

One

Step

Mal

aria

P.F

Tes

t (Ca

sset

te)

5223

52Bl

ue C

ross

Bio

-Med

ical (

Beiji

ng) C

o., L

td.

94.9

NA

99.0

NA

NA

0N

A1.

51.

30.

04

Yes

OnSi

te M

alar

ia P

f Ag

Rapi

d Te

stj

R011

4CCT

K Bi

otec

h, In

c.75

.0N

A99

.0N

AN

A0.

0N

A0.

00.

00.

26

Yes

Para

chec

k® P

f-Ra

pid

Test

for P

. fal

cipa

rum

Mal

aria

Dev

ice

(Ver

.3)

3020

3002

5Or

chid

Bio

med

ical

Sys

tem

s 95

.9N

A98

.0N

AN

A0

NA

0.0

1.3

0.0

4Ye

sPa

rach

eck®

Pf-

Rapi

d Te

st fo

r P. f

alcip

arum

Mal

aria

Dip

stic

k (Ve

r.3)j

3020

4002

5Or

chid

Bio

med

ical

Sys

tem

s 70

.4N

A99

.0N

AN

A0

NA

0.0

0.9

0.0

4N

oPa

raH

IT®

- f

Ver.

1 (D

evic

e)55

IC10

4-50

ARKR

AY H

ealth

care

Pvt

. Ltd

.n84

.9N

A10

0.0

NA

NA

0.0

NA

0.0

0.0

0.0

3Ye

sm

Para

HIT

® -

f Ver

. 1 (D

ipst

ick)

55IC

103-

50AR

KRAY

Hea

lthca

re P

vt. L

td.n

80.8

NA

99.0

NA

NA

0.0

NA

1.4

2.5

0.0

3Ye

sm

Rapi

d 1-

2-3®

Hem

a® C

asse

tte

Mal

aria

PF

MAL

-PF-

CAS/

25 (1

00)

Hem

a Di

agno

stic

Sys

tem

s93

.0N

A10

0.0

NA

NA

2.9

(139

)N

A0.

00.

00.

26

Yes

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

(HRP

II)C1

0RH

A25

Rapi

GEN

Inc.

88.0

NA

99.0

NA

NA

0.7

NA

0.0

0.5

(207

)0.

26

Yes

Righ

tSig

n® M

alar

ia P

.f. R

apid

Tes

t Cas

sett

e (W

hole

Blo

od)

IMPF

-C51

Han

gzho

u Bi

otes

t Bio

tech

Co.

, Ltd

.79

.0N

A10

0.0

NA

NA

0.0

NA

0.0

0.0

0.0

6Ye

sSD

Bio

line

Mal

aria

Ag

P.f (

HRP

2/pL

DH)j,k

05FK

90St

anda

rd D

iagn

ostic

s, In

c.88

.0N

A10

0.0

NA

NA

0.7

NA

0.0

0.0

0.0

6Ye

sm

SD B

IOLI

NE

Mal

aria

Ag

Pf05

FK50

Stan

dard

Dia

gnos

tics,

Inc.

95.0

NA

99.0

NA

NA

0.0

NA

2.9

0.0

0.0

5Ye

sm

Trus

ty™

Mal

aria

Ant

igen

P.f.

test

A03-

01-3

22Ar

tron

Lab

orat

orie

s In

c.88

.8N

A10

0.0

NA

NA

4.4

(135

)N

A2.

95.

2 (2

30)

0.7

4Ye

sPf

and

pan

ABON

™ P

lus

Mal

aria

P.f/

Pan

Rapi

d Te

st D

evic

e (W

hole

Blo

od)

IMA-

T402

ABON

Bio

phar

m (H

angz

hou)

Co.

Ltd

85.7

5.9

100.

097

.10.

00.

00.

00.

00.

40.

04

No

ACCU

CARE

ON

E ST

EP M

ALAR

IA P

f/Pa

n An

tigen

Tes

tM

AGC

25LA

B-CA

RE D

iagn

ostic

s (In

dia)

PVT

. LTD

.66

.037

.192

.097

.10.

30.

0 (1

39)

0.0

(199

)0.

07.

3 (2

34)

0.4

5N

oAd

vanc

ed Q

ualit

y™ R

apid

Mal

aria

Tes

t (Pf

/Pan

) IT

P110

05In

Tec

Prod

ucts

, Inc

.88

.060

.010

0.0

97.1

0.3

(389

)6.

7 (1

34)

0.0

(197

)1.

48.

7 (2

31)

2.1

5N

oAd

vant

age

Mal

Car

dIR

2210

25J.

Mitr

a &

Co.

Pvt

. Ltd

.30

.094

.394

.097

.11.

50.

70.

50.

00.

40.

05

No

Adva

ntag

e M

alar

ia P

an +

Pf C

ard

IR23

1025

J. M

itra

& C

o. P

vt. L

td.

84.0

100.

010

0.0

100.

03.

50.

00.

00.

0 (6

9)0.

00.

25

Yes

ATOM

ORAP

ID™

MAL

ARIA

(PF/

PAN

)M

MAL

01At

omo

Diag

nost

ics

PTY

Lim

ited

90.0

22.9

100.

097

.10.

0 (3

99)

2.9

0.0

0.0

0.0

(207

)0.

26

No

Sum

ma

ry

ro

un

dS

1-6


Prod

uct

Prod

uct

code

Man

ufac

ture

r

Pane

l det

ectio

n sc

orea

False

-pos

itive

rat

es (%

)To

tal f

alse

-pos

itive

ra

tesb

(%)

Inva

lid

rate

(%

)lRo

und

Mee

ts

WH

O

proc

urem

ent

crite

ria

200

pa

rasit

es/μ

L20

00 o

r 50

00

para

sites

/μL

200

pa

rasit

es/μ

L20

00 o

r 50

00

para

sites

/μL

Clea

n-ne

gativ

e sa

mpl

es

Pf samplesc

Pv samplesd

Pf samplesc

Pv samplesd

Pf s

ampl

esPv

sam

ples

Pf s

ampl

esPv

sam

ples

False

-po

sitiv

e

non-

Pf

infe

ctio

ne

False

-po

sitiv

e

Pf

infe

ctio

nf

False

-po

sitiv

e

non-

Pf

infe

ctio

ng

False

-po

sitiv

e

Pf

infe

ctio

nh

False

-pos

itive

Pl

asm

odiu

m sp

p.

Infe

ctio

ni

AZOG

Mal

aria

pf (

HRPI

I)/pf

(LDH

)/ (P

AN-L

DH) A

ntig

en D

etec

tion

Devic

ekM

FV-1

24F

AZOG

, IN

C.62

.20.

098

.088

.20.

0 (3

90)

5.2

0.0

0.0

1.7

(231

)0.

34

No

BION

OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kitj

RG19

-08

BioN

ote,

Inc.

83.0

68.6

100.

010

0.0

0.0

0.0

0.0

0.0

0.5

0.0

6N

oBi

oTra

cer™

Mal

aria

P.f/

PAN

Rap

id C

ardj

1701

2Bi

o Fo

cus

Co.,

Ltd.

83.0

100.

010

0.0

100.

04.

00.

00.

00.

00.

00.

06

Yes

Care

Star

t™ M

alar

ia/P

regn

ancy

Com

bo (p

LDH

/HRP

2/H

CG)

G02

21Ac

cess

Bio

, Inc

.83

.894

.310

0.0

97.1

2.3

1.4

(139

)0.

0 (1

94)

1.4

0.0

0.2

3Ye

sCa

reSt

art™

Mal

aria

HRP

2/pL

DH (P

f/PA

N) C

OMBO

G013

1m/G

0131

-ET

Acce

ss B

io, I

nc.

90.0

94.3

100.

010

0.0

1.5

0.7

0.0

0.0

0.4

0.0

5Ye

sm

Care

Star

t™ M

alar

ia p

LDH

3 L

ine

Test

G

0121

Acce

ss B

io, I

nc.

88.9

91.4

100.

010

0.0

1.3

0.7

6.1

0.0

0.5

0.0

3Ye

sCa

reSt

art™

Mal

aria

Scr

een

G02

31Ac

cess

Bio

, Inc

.86

.988

.610

0.0

100.

01.

82.

10.

00.

02.

5 (1

99)

0.1

3Ye

sCo

re™

Mal

aria

Pan

Pf

MAL

-190

024

Core

Dia

gnos

tics

Ltd.

99.0

26.5

100.

029

.40.

033

.80.

042

.732

.2 (2

30)

0.3

4N

odi

agno

stic

ks M

ALAR

IA (P

an/P

f) Ca

sset

te

MPN

FWBC

1007

.4SS

A Di

agno

stic

s &

Bio

tech

Sys

tem

s98

.051

.410

0.0

97.1

0.0

(394

)0.

00.

00.

0 (6

9)2.

50.

33

No

DIAQ

UIC

K M

alar

ia P

.f/Pa

n Ca

sset

teZ1

1200

CEDI

ALAB

Gm

bH90

.082

.910

0.0

97.1

0.3

2.9

0.0

1.5

(67)

2.1

0.2

5Ye

sEz

Dx™

Mal

aria

Pan

/Pf R

apid

test

det

ectio

n Ki

tjRK

MAL

001

Advy

Che

mic

al P

rivat

e Li

mite

d78

.088

.610

0.0

100.

00.

30.

00.

00.

01.

40.

06

Yes

Firs

t Res

pons

e® M

alar

ia A

g. p

LDH

/HRP

2 Co

mbo

Car

d Te

stI1

6FRC

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.85

.074

.310

0.0

100.

00.

30.

00.

00.

00.

00.

05

No

Firs

t Res

pons

e® M

alar

ia A

g. p

LDH

/HRP

2 Co

mbo

Car

d Te

stPI

16FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

82.0

91.4

100.

010

0.0

1.5

0.0

0.0

0.0

1.9

(207

)0.

16

Yes

Firs

tSig

n™ P

araV

iew

(Pan

+Pf)

2101

CB-2

5U

nim

ed In

tern

atio

nal I

nc.

87.8

61.8

100.

010

0.0

0.3

1.5

0.0

0.0

2.6

0.0

4N

oG

enBo

dy™

Mal

aria

Pf/

Pan

AgM

ALAG

100

Gen

Body

Inc.

84.0

54.3

100.

097

.10.

00.

00.

00.

00.

0 (2

35)

0.2

5N

oG

ened

ia®

Mal

aria

P.f/

Pan

Ag R

apid

Tes

t 20

-014

6-01

Gree

n Cr

oss M

edica

l Scie

nce C

orp.

(Kor

ea)

67.0

17.1

96.0

88.6

0.0

13.6

0.0

7.1

10.6

0.1

5N

oH

umas

is M

alar

ia P

.f/Pa

n An

tigen

Tes

tjAM

AL-7

025

Hum

asis,

Co.

, Ltd

.90

.091

.410

0.0

97.1

0.5

(396

)0.

0 (1

38)

0.0

(199

)1.

40.

9 (2

35)

0.7

5Ye

sH

umas

is M

alar

ia P

.f/Pa

n An

tigen

Tes

tAN

MAL

-702

5H

umas

is C

o., L

td.

89.0

62.9

99.0

97.1

0.0

0.7

(139

)0.

01.

40.

50.

16

No

ICT

Mal

aria

Dua

l Tes

tM

L03

ICT

INTE

RNAT

ION

AL93

.040

.098

.094

.30.

34.

30.

52.

93.

00.

05

No

IMM

UN

OQU

ICK

CON

TACT

MAL

ARIA

+4

0525

K25

Bios

ynex

75.8

17.1

98.0

94.3

1.8

(395

)5.

1 (1

38)

0.0

0.0

2.0

0.3

3N

oIs

It…

Mal

aria

Pf/

Pv D

evic

eAL

030

Med

sour

ce O

zone

Bio

med

ical

s88

.091

.499

.010

0.0

0.5

(395

)0.

00.

00

(68)

1.0

(206

)0.

86

Yes

Mal

aria

Pan

Tes

t M

AL-W

23N-

001

Dim

a • G

esell

scha

ft fü

r Dia

gnos

tika m

bH54

.60.

097

.048

.62.

815

.70.

017

.144

.00.

03

No

Mal

aria

Pf./

Pan

Antig

en (M

AL P

f/Pa

n) T

est K

itA0

3-18

-322

Artr

on L

abor

ator

ies

Inc.

61.0

2.9

95.0

97.1

0.0

(3.9

8)4.

30.

0 (1

99)

0.0

0.9

0.2

5N

oM

alar

ia p

f (H

RP II

) / (P

AN-p

LDH

) Ant

igen

Det

ectio

n Te

st D

evic

eM

FV-1

24R

AZOG

, Inc

.95

.00.

010

0.0

94.3

0.0

(395

)7.

98.

10.

05.

5 (1

99)

0.3

3N

oM

alar

ia p

f (H

RP II

) / P

AN (p

LDH

) Ant

igen

Det

ectio

n Te

st D

evic

e1-

13-1

01-1

Uni

ted

Biot

ech,

Inc.

63

.32.

910

0.0

85.3

0.0

0.0

(135

)0.

00.

00.

00.

14

No

Mal

aria

pf (

pLDH

) / P

AN-p

LDH

Tes

t Dev

ice

MFV

-124

AZOG

, Inc

.41

.08.

697

.045

.722

.547

.91.

535

.781

.3 (2

35)

0.1

5N

oM

alar

ia P

f/ P

ANG

M00

4Ge

nom

ix M

olec

ular

Dia

gnos

tics P

vt.Lt

d.39

.82.

994

.997

.10.

30.

70.

00.

00.

00.

04

No

Mal

aria

Pf/

Pan

One

Step

Rap

id T

est

RT 2

0222

Zhej

iang

Orie

nt G

ene

Biot

ech

Co., L

td.

89.0

91.4

100.

010

0.0

0.0

(398

)0.

7 (1

38)

0.0

(199

)0.

0 (6

9)0.

4 (2

32)

1.0

5Ye

sM

alas

can™

Dev

ice

- Ra

pid

test

for M

alar

ia P

f/Pa

n50

4020

25Ze

phyr

Bio

med

ical

Sys

tem

s82

.857

.197

.010

0.0

1.0

(392

)0.

7 (1

36)

1.0

(194

)0.

0 (6

8)1.

0 (1

95)

1.9

3N

oM

eDiP

ro M

alar

ia A

g H

RP2/

pLDH

Com

boIR

-005

1KFo

rmos

a Bi

omed

ical

Tech

nolo

gy C

orp.

69.4

2.9

99.0

0.0

0.0

(391

)0.

00.

01.

50.

90.

14

No

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.77

.071

.410

0.0

100.

01.

30.

00.

00.

00.

50.

06

No

Nan

oSig

n M

alar

ia p

f/pa

n Ag

3.0

RMAP

10Bi

olan

d, L

td.

92.9

97.1

100.

010

0.0

0.8

0.0

0.0

0.0

0.4

0.0

4Ye

sN

anoS

ign

Mal

aria

Pf/

Pv A

gRM

AD10

Biol

and,

Ltd

6.1

8.6

89.9

100.

00.

50.

0 (1

39)

0.0

0.0

0.0

0.1

3N

oN

G-T

est M

ALAR

IA P

f/Pa

n (p

LDH

)NG

-MAL

-W23

-001

SARL

NG

Bio

tech

, Z.A

.90

.065

.710

0.0

94.3

0.5

(399

)9.

30.

04.

315

.30.

15

No

One

Step

Mal

aria

P.f/

Pan

Test

W56

-CG

uang

zhou

Won

dfo

Biot

ech

Co. L

td.

37.4

85.7

95.0

100.

08.

4 (3

83)

0.0

(137

)0.

0 (1

94)

0.0

(68)

4.1

(195

)2.

43

No

One

Step

Mal

aria

P.f/

Pan

Who

le B

lood

Tes

tW

62-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.77

.014

.310

0.0

100.

00.

00.

00.

00.

00.

00.

06

No

OnSi

te M

alar

ia P

f/Pa

n Ag

Rap

id T

estj

R011

3CCT

K Bi

otec

h, In

c.78

.085

.799

.097

.10.

0 (3

98)

0.0

0.5

1.4

0.0

(207

)0.

26

Yes

OptiM

AL-I

T 71

0024

Diam

ed -

A D

ivis

ion

of B

io-R

ad50

.597

.196

.068

.61.

50.

00.

520

.3 (6

9)2.

0 (1

98)

0.5

3N

oPa

raH

IT -

Tot

al V

er. 1

.0 (D

evic

e)55

IC20

4-10

ARKR

AY H

ealth

care

Pvt

. Ltd

.n84

.782

.499

.091

.20.

30.

00.

53.

0 (6

7)0.

00.

14

Yes

Para

HIT

- T

otal

Ver

. 1.0

(Dip

stic

k)55

IC20

3-10

ARKR

AY H

ealth

care

Pvt

. Ltd

.n76

.561

.810

0.0

94.1

0.8

0.0

0.0

1.5

0.0

0.0

4N

oPa

rasc

reen

® -

Rapi

d Te

st fo

r Mal

aria

Pan

/Pfj

5030

3002

5Ze

phyr

Bio

med

ical

s79

.097

.110

0.0

100.

02.

30.

00.

00.

00.

00.

06

Yes

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

Dia

gnos

tics,

Inc.

79.0

91.4

99.0

100.

06.

51.

40.

5 (1

99)

0.0

7.2

0.1

6Ye

s

Tabl

e S2

(con

tinue

d)

(con

tinue

d)


Prod

uct

Prod

uct

code

Man

ufac

ture

r

Pane

l det

ectio

n sc

orea

False

-pos

itive

rat

es (%

)To

tal f

alse

-pos

itive

ra

tesb

(%)

Inva

lid

rate

(%

)lRo

und

Mee

ts

WH

O

proc

urem

ent

crite

ria

200

pa

rasit

es/μ

L20

00 o

r 50

00

para

sites

/μL

200

pa

rasit

es/μ

L20

00 o

r 50

00

para

sites

/μL

Clea

n-ne

gativ

e sa

mpl

es

Pf samplesc

Pv samplesd

Pf samplesc

Pv samplesd

Pf s

ampl

esPv

sam

ples

Pf s

ampl

esPv

sam

ples

False

-po

sitiv

e

non-

Pf

infe

ctio

ne

False

-po

sitiv

e

Pf

infe

ctio

nf

False

-po

sitiv

e

non-

Pf

infe

ctio

ng

False

-po

sitiv

e

Pf

infe

ctio

nh

False

-pos

itive

Pl

asm

odiu

m sp

p.

Infe

ctio

ni

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pan

(HRP

II/pL

DH)

C30R

HA2

5Ra

piG

EN In

c.90

.091

.410

0.0

94.3

0.0

(399

)0.

00.

02.

92.

4 (2

07)

0.1

6Ye

sRi

ghtS

ign™

Mal

aria

P.f.

/Pan

Rap

id T

est C

asse

tte

IMPN

-C52

Han

gzho

u Bi

otes

t Bio

tech

Co.

Ltd

.74

.040

.094

.088

.62.

02.

90.

55.

714

.00.

05

No

SD B

IOLI

NE

Mal

aria

Ag

P.f/

Pan

05FK

60St

anda

rd D

iagn

ostic

s In

c.94

.091

.499

.097

.10.

80.

70.

51.

40.

00.

05

Yesm

SD B

IOLI

NE

Mal

aria

Ag

Pf/ P

an05

FK66

Stan

dard

Dia

gnos

tics

Inc.

90

.894

.110

0.0

100.

01.

0 (3

85)

0.0

(130

)0.

0 (1

95)

0.0

(67)

1.3

(226

)2.

84

Yes

SD B

IOLI

NE

Mal

aria

Ag

05FK

40St

anda

rd D

iagn

ostic

s In

c.16

.297

.193

.910

0.0

0.8

0.0

0.0

0.0

0.0

0.0

3N

oVi

kia®

Mal

aria

Ag

Pf/P

an41

2499

IMAC

CESS

S.A

.S86

.05.

797

.094

.30.

00.

7 (1

39)

0.5

(199

)0.

0 (6

9)1.

3 (2

35)

0.3

5N

oPf

and

Pv/

Pvom

Adva

nced

Qua

lity ™

One S

tep

Mal

aria

(Pf

/Pv)

Tri-l

ine T

est (

who

le bl

ood)

jIT

P110

03 T

C40

InTe

c Pr

oduc

ts, I

nc.

74.0

48.6

100.

010

0.0

0.0

(396

)0.

00.

0 (1

99)

0.0

(69)

0.0

(207

)0.

76

No

Adva

ntag

e M

alar

ia C

ard

IR21

1025

J. M

itra

& C

o. P

vt. L

td.

77.8

31.4

99.0

100.

00.

50.

70.

00.

00.

00.

03

No

ASAN

Eas

y Te

st®

Mal

aria

Pf/

Pan

AgAM

4650

-KAS

AN P

harm

aceu

tical

Co.

, Ltd

81

.034

.399

.010

0.0

16.5

0.0

85.5

0.0

0.4

(235

)0.

25

No

BION

OTE

MAL

ARIA

P.f.

& P

.v. A

g Ra

pid

Test

Kit

RG19

-12

Bion

ote,

Inc.

92.9

97.1

98.0

100.

00.

30.

71.

5 (1

97)

0.0

4.0

0.0

3Ye

sBi

oTra

cer™

Mal

aria

P.f/

P.v

Rapi

d Ca

rd17

412

Bio

Focu

s Co

., Lt

d.91

.094

.310

0.0

100.

00.

00.

00.

00.

0 (6

9)0.

00.

16

Yes

Care

Star

t™ M

alar

ia H

RP2/

pLDH

(Pf/

Pv) C

OMBO

G016

1m/G

0161

-ET

Acce

ss B

io, I

nc.

90.8

94.1

100.

010

0.0

0.3

0.0

1.0

1.5

0.0

0.0

4Ye

sm

Care

Star

t™ M

alar

ia H

RP2/

pLDH

(Pf/

VOM

) COM

BOG0

171/

G017

1-ET

Acce

ss B

io, I

nc.

89.8

91.2

100.

010

0.0

0.3

0.7

0.5

2.9

0.0

0.0

4Ye

sCo

re™

Mal

aria

Pv/

PfM

AL-1

9002

2Co

re D

iagn

ostic

s98

.060

.010

0.0

97.1

0.3

0.0

0.0

0.0

4.0

0.1

3N

oCo

rete

sts®

One

Ste

p M

alar

ia P

f/Pv

Ag

Test

Dev

ice

B42-

21/B

42-2

2Co

re T

echn

olog

y Co

., Lt

d.78

.082

.998

.010

0.0

2.8

(399

)0.

0 (1

38)

1.0

0.0

0.0

(207

)0.

56

Yes

EzDx

™ M

alar

ia P

v/Pf

Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

03Ad

vy C

hem

ical

Priv

ate

Lim

ited

76.0

77.1

100.

010

0.0

1.3

1.4

0.0

1.4

3.9

0.0

6Ye

sFa

lciV

ax™

- R

apid

Tes

t for

Mal

aria

Pv/

Pfj

5030

1002

5Ze

phyr

Bio

med

ical

s80

.010

0.0

99.0

100.

00.

50.

00.

50.

01.

40.

06

Yes

Firs

t Res

pons

e® M

alar

ia A

g Pf

/Pv

Card

Tes

tPI

19FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

85.0

71.4

100.

010

0.0

0.0

0.0

0.0

(199

)0.

00.

5 (2

07)

0.2

6N

oH

iSen

s M

alar

ia A

g P.

f/P.

v Co

mbo

Car

dH

R312

3H

BI C

o., L

td.

89.8

79.4

100.

094

.10.

3 (3

91)

0.0

0.5

0.0

0.4

0.1

4Ye

sH

iSen

s M

alar

ia A

g P.

f/VO

M C

ombo

Car

dH

R332

3H

BI C

o., L

td.

89.8

76.5

100.

091

.20.

00.

00.

50.

00.

00.

04

Yes

Hum

asis

Mal

aria

P.f/

P.v

Antig

en T

est

AMFV

-702

5H

umas

is, C

o., L

td.

92.9

100.

010

0.0

100.

00.

50.

70.

51.

51.

30.

04

Yes

Hum

asis

Mal

aria

P.f/

P.v

Antig

en T

est

ANM

IV-7

025

Hum

asis,

Co.

, Ltd

.88

.091

.410

0.0

100.

00.

30.

70.

00.

01.

0 (2

07)

0.1

6Ye

sKH

B® M

alar

ia A

g P.

f/P.

v Ra

pid

Test

KH-R

-07-

50Sh

angh

ai K

ehua

Bio

-eng

inee

ring

Co., L

td.

91.0

48.6

100.

010

0.0

0.3

0.0

0.0

0.0

0.0

0.0

6N

oM

alar

ia p

f (H

RP II

) / p

v (p

LDH

) Ant

igen

Det

ectio

n Te

st D

evic

e1-

13-1

01-3

Uni

ted

Biot

ech,

Inc.

60

.20.

092

.926

.50.

50.

0 (1

35)

3.1

(195

)1.

50.

0 (2

30)

0.5

4N

oM

alar

ia p

f (H

RP II

) / p

v (p

LDH

) Ant

igen

Det

ectio

n Te

st D

evic

e M

FV-1

24V

AZOG

, Inc

.79

.80.

010

0.0

20.0

0.0

1.4

0.0

0.0

0.0

(199

)0.

13

No

Mal

aria

Pf (

HRP

II)/ P

V (p

LDH

) Ant

igen

Det

ectio

n Te

st D

evic

e G

M00

6Ge

nom

ix M

olec

ular

Dia

gnos

tics P

vt. L

td.

85.0

74.3

97.0

94.3

1.5

(391

)6.

5 (1

38)

3.6

(195

)2.

90.

9 (2

32)

2.5

5N

oM

alar

ia P

f/Pv

GM

002

Geno

mix

Mol

ecul

ar D

iagn

ostic

s Pvt

.Ltd.

40.8

0.0

94.9

5.9

0.8

0.7

0.5

0.0

0.9

0.0

4N

oM

alar

ia P

V/PF

(pLD

H/H

RP2)

Ant

igen

Tes

t In

f-72

Nan

tong

Ege

ns B

iote

chno

logy

Co.

, Ltd

.90

.051

.410

0.0

97.1

0.0

(395

)0.

0 (1

37)

0.5

(198

)0.

00.

0 (2

03)

1.3

6N

oM

aler

isca

n® M

alar

ia P

f/PA

N (P

v, Pm

, Po)

3 L

ine

Antig

en T

est

MAT

-PF/

PAN-

50Bh

at B

io-T

ech

Indi

a (P

) Ltd

.84

.062

.910

0.0

100.

027

.3 (3

99)

5.8

(139

)87

.4 (1

99)

4.3

(69)

3.0

(232

)0.

75

No

Mer

iscr

een

Mal

aria

Pf/

Pv A

gM

FLRP

D-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.76

.025

.710

0.0

100.

02.

00.

74.

00.

01.

00.

06

No

One

Step

Mal

aria

P.F

/P.V

Tes

t (Ca

sset

te)

5233

52Bl

ue C

ross

Bio

-Med

ical (

Beiji

ng) C

o., L

td.

92.0

100.

010

0.0

100.

021

.553

.69.

034

.377

.10.

05

No

One

Step

Mal

aria

P.f/

P.v

Who

le B

lood

Tes

tjW

056-

CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

78.0

0.0

99.0

74.3

0.0

(399

)0.

05.

50.

00.

00.

16

No

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

d Te

stj

R011

2CCT

K Bi

otec

h, In

c.74

.080

.098

.010

0.0

0.0

(399

)1.

40.

00.

00.

0 (2

07)

0.2

6N

oPa

raHI

T®fV

Rap

id te

st fo

r P. f

alcip

arum

and

P. v

ivax M

alar

ia -

Devi

ce55

IC40

2-50

ARKR

AY H

ealth

care

Pvt

. Ltd

.n63

.037

.191

.085

.72.

0 (3

99)

5.7

0.5

2.9

6.4

0.1

5N

oQu

ickP

rofil

e™ M

alar

ia P

f/Pv

Tes

t71

050

Lum

iqui

ck D

iagn

ostic

s, In

c.78

.025

.710

0.0

100.

04.

00.

04.

00.

00.

00.

16

No

RAPI

D 1-

2-3®

HEM

A CA

SSET

TE M

ALAR

IA P

F/PV

TES

TM

AL-P

FV-

CAS/

25(1

00)

Hem

a Di

agno

stic

Sys

tem

s, LL

C92

.979

.410

0.0

100.

00.

00.

70.

01.

54.

30.

04

Yes

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pv

(HRP

II/pL

DH)

C40R

HA2

5Ra

piG

EN In

c.92

.091

.410

0.0

100.

02.

5 (3

99)

0.0

1.0

2.9

4.4

(207

)0.

26

Yes

SD B

iolin

e M

alar

ia A

g P.

f/P.

vj05

FK80

Stan

dard

Dia

gnos

tics,

Inc.

92.0

94.3

100.

010

0.0

0.5

0.7

0.0

0.0

1.9

0.0

6Ye

sm

Trus

ty™

Mal

aria

Ant

igen

P.f.

/p.v.

test

A03-

12-3

22Ar

tron

Lab

orat

orie

s In

c.88

.838

.299

.010

0.0

13.3

27.4

(135

)16

.0 (1

94)

19.4

(67)

32.0

(231

)0.

54

No

Tabl

e S2

: Mal

aria

RDT

pha

se-2

per

form

ance

in r

ound

s 3–

6 ag

ains

t w

ild-t

ype

(clin

ical

) sa

mpl

es c

onta

inin

g P.

falc

ipar

um (

Pf)

and

P. v

ivax

(Pv

) at

low

(200

)

and

high

(200

0 or

500

0) p

aras

ite

dens

ity

(par

asit

es/μ

L) a

nd c

lean

-neg

ativ

e sa

mpl

es (c

ontin

ued)

Sum

ma

ry

ro

un

dS

1-6


Prod

uct

Prod

uct

code

Man

ufac

ture

r

Pane

l det

ectio

n sc

orea

False

-pos

itive

rat

es (%

)To

tal f

alse

-pos

itive

ra

tesb

(%)

Inva

lid

rate

(%

)lRo

und

Mee

ts

WH

O

proc

urem

ent

crite

ria

200

pa

rasit

es/μ

L20

00 o

r 50

00

para

sites

/μL

200

pa

rasit

es/μ

L20

00 o

r 50

00

para

sites

/μL

Clea

n-ne

gativ

e sa

mpl

es

Pf samplesc

Pv samplesd

Pf samplesc

Pv samplesd

Pf s

ampl

esPv

sam

ples

Pf s

ampl

esPv

sam

ples

False

-po

sitiv

e

non-

Pf

infe

ctio

ne

False

-po

sitiv

e

Pf

infe

ctio

nf

False

-po

sitiv

e

non-

Pf

infe

ctio

ng

False

-po

sitiv

e

Pf

infe

ctio

nh

False

-pos

itive

Pl

asm

odiu

m sp

p.

Infe

ctio

ni

Pf, P

f an

d Pv

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.85

.091

.410

0.0

100.

00.

00.

00.

50.

00.

00.

06

Yes

Pf, P

v an

d Pa

nCo

re™

Mal

aria

Pan

/Pv/

Pf

MAL

-190

026

Core

Dia

gnos

tics

92.9

11.4

99.0

94.3

0.3

(391

)0.

0 (1

37)

0.0

(197

)1.

43.

5 (1

98)

1.0

3N

odi

agno

stic

ks M

ALAR

IA (P

an/P

v/Pf

) Cas

sett

eM

PNVF

C100

7.5

SSA

Diag

nost

ics

& B

iote

ch S

yste

ms

93.9

11.4

99.0

94.3

0.0

(389

)0.

0 (1

39)

0.0

(196

)2.

9 (6

9)4.

0 (1

99)

1.1

3N

oPa

n on

lyAd

vant

age

Pan

Mal

aria

Car

dIR

0130

25J.

Mitr

a &

Co.

Pvt

. Ltd

.77

.010

0.0

98.0

100.

0N

AN

AN

AN

A0.

40.

05

Yes

AZOG

hCG

Mal

aria

Det

ectio

n Te

st D

evic

eM

PT-1

24AZ

OG, I

NC.

61.2

0.0

9955

.9N

AN

AN

AN

A2.

20.

24

No

Care

Star

t™ M

alar

ia p

LDH

(PAN

)G

0111

Acce

ss B

io, I

nc.

84.0

88.6

99.0

97.1

NA

NA

NA

NA

0.0

0.0

5Ye

sm

diag

nost

icks

MAL

ARIA

(Pan

) Cas

sett

e M

PNW

BC10

07.3

SSA

Diag

nost

ics

& B

iote

ch S

yste

ms

16.2

54.3

92.9

100.

0N

AN

AN

AN

A0.

00.

33

No

Para

bank

™ D

evic

e -

Rapi

d te

st fo

r Mal

aria

Pan

50

3010

25Ze

phyr

Bio

med

ical

Sys

tem

s17

.262

.990

.910

0.0

NA

NA

NA

NA

0.5

0.2

3N

o

NA,

not

app

licab

lePf

, Plas

mod

ium

falc

ipar

um

Pv,

Plas

mod

ium

viv

ax

pan

, Pla

smod

ium

spec

ies

Pvom

, Pla

smod

ium

viv

ax, o

vale

and

mal

aria

ea

A sa

mpl

e is

con

side

red

dete

cted

onl

y if

all R

DTs

from

bot

h lo

ts re

ad b

y th

e fir

st

tech

nici

an, a

t min

imum

spe

cifie

d re

adin

g tim

e, a

re p

ositi

veb

The

tota

l num

ber o

f tim

es a

pos

itive

resu

lt fo

r mal

aria

was

gen

erat

ed w

hen

it sh

ould

no

t hav

e be

en

c Ro

und

1, n

=79;

Rou

nd 2

, n=1

00; R

ound

3, n

=99;

Rou

nd 4

, n=9

8; R

ound

5, n

=100

; Ro

und

6, n

=100

d Ro

und

1, n

=20;

Rou

nd 2

, n=4

0; R

ound

3, n

=35;

Rou

nd 4

, n=3

4; R

ound

5, n

=35;

Ro

und

6, n

=35

e Fo

r com

bina

tion

test

s, pa

n or

Pv

line,

onl

y, po

sitiv

e in

dica

tes

a fa

lse

posi

tive

non

P. fa

lcip

arum

infe

ctio

n (R

ound

1 n

=316

; Rou

nd 2

, n=4

00; R

ound

3, n

=396

; Ro

und

4, n

=392

; Rou

nd 5

, n=4

00);

Roun

d 6,

n=4

00)

f Pf

line

pos

itive

indi

cate

s a

fals

e po

sitiv

e P.

falc

ipar

um in

fect

ion

(Rou

nd 1

, n=8

0;

Roun

d 2,

n=1

60; R

ound

3, n

=140

; Rou

nd 4

, n=1

36; R

ound

5, n

=140

; Rou

nd 6

, n=1

40)

g

For c

ombi

natio

n te

sts,

pan

or P

v lin

e, o

nly,

posi

tive

indi

cate

s a

fals

e po

sitiv

e no

n-P.

falc

ipar

um in

fect

ion

(Rou

nd 1

, n=1

58, R

ound

2, n

=200

; Rou

nd 3

, n=1

98;

Roun

d 4,

n=1

96; R

ound

5, n

=200

; Rou

nd 6

, n=2

00)

h Pf

line

pos

itive

indi

cate

s a

fals

e po

sitiv

e P.

falc

ipar

um in

fect

ion

(Rou

nd 1

, n=4

0;

Roun

d 2,

n=8

0, R

ound

3, n

=70;

Rou

nd 4

, n=6

8; R

ound

5, n

=70;

Rou

nd 6

, n=7

0)i

Roun

d 1,

n=1

68; R

ound

2, n

=200

; Rou

nd 3

, n=2

00; R

ound

4, n

=232

; Rou

nd 5

, n=2

36;

Roun

d 6,

n=2

08j

Prod

uct r

esub

mis

sion

, re

sults

from

mos

t rec

ent R

ound

of t

estin

g re

plac

e pr

evio

us

resu

lts. R

efer

to T

able

S1.

k

PDS

pres

ente

d in

the

tabl

e is

bas

ed o

n a

posi

tive

Pf te

st li

ne (e

ither

HRP

2 or

Pf-

pLDH

). Fo

r tes

t lin

e sp

ecifi

c re

sults

refe

r to

the

tabl

es a

nd a

nnex

es in

the

full

repo

rts.

l Ro

und

1, n

=954

; Rou

nd 2

, n=1

240;

Rou

nd 3

, n=1

204;

Rou

nd 4

, n=1

192;

Ro

und

5, n

=121

4 ; R

ound

6, n

=121

0m

Indi

cate

s a

WH

O pr

equa

lified

pro

duct

n

Span

Dia

gnos

tics

Ltd.

is n

ow A

RKRA

Y H

ealth

care

Pvt

. Ltd

.

Perf

orm

ance

mea

sure

Reco

mm

ende

d W

HO

pr

ocur

emen

t cr

iteria

Pa

nel d

etec

tion

scor

e fo

r Pf a

nd P

v 20

0/µL

sam

ples

≥ 75

%

Fals

e-po

sitiv

e ra

tes

agai

nst c

lean

-neg

ativ

es

< 10

%

Inva

lid ra

te<

5% o

f tes

ts c

ondu

cted

Tabl

e S2

(con

tinue

d)


Tabl

e S3

: Mal

aria

RDT

rou

nds

3–6

heat

sta

bilit

y re

sult

s on

a c

ultu

red

P. fa

lcip

arum

sam

ple

at lo

w (2

00)

and

high

(200

0) p

aras

ite

dens

ity

(par

asit

es/μ

L).

Posi

tivi

ty r

ate

at b

asel

ine

(roo

m t

empe

ratu

re)

and

afte

r 60

day

s’ in

cuba

tion

at 3

5 °C

and

45

°C

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Perc

enta

ge p

ositi

ve t

est

resu

lts f

or P

. fal

cipa

rum

(P

f lin

e)

Perc

enta

ge p

ositi

ve t

est

resu

lts f

or P

. fal

cipa

rum

(P

f lin

e)

Perc

enta

ge p

ositi

ve t

est

resu

lts f

or P

. fal

cipa

rum

(p

an li

ne)

Perc

enta

ge p

ositi

ve t

est

resu

lts f

or P

. fal

cipa

rum

(p

an li

ne)

Roun

d20

0 pa

rasit

es/µ

L20

00 p

aras

ites/

µL20

0 pa

rasit

es/µ

L20

00 p

aras

ites/

µL

Base

line

35 °C

45 °C

Base

line

35 °C

45 °C

Base

line

35 °C

45 °C

Base

line

35 °C

45 °C

Num

ber

of t

ests

pos

itive

Num

ber

of t

ests

pos

itive

Num

ber

of t

ests

pos

itive

Num

ber

of t

ests

pos

itive

Lots

1 a

nd 2

com

bine

dLo

ts 1

and

2 c

ombi

ned

Lots

1 a

nd 2

com

bine

dLo

ts 1

and

2 c

ombi

ned

Pf o

nly

ABON

™ M

alar

ia P

.f. R

apid

Tes

t Dev

ice

(Who

le B

lood

)IM

A-40

2AB

ON B

ioph

arm

(Han

gzho

u) C

o. L

td15

.015

.017

.010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

4Ad

vanc

ed Q

ualit

y™ O

ne S

tep

Mal

aria

Pf T

esta

ITP11

002T

C1/TC

40In

Tec

Prod

ucts

, Inc

.93

.396

.790

.010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

5Ad

vant

age

P.f.

Mal

aria

Car

dIR

0160

25J.

Mitr

a &

Co.

Pvt

. Ltd

.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A5

BION

OTE

MAL

ARIA

P.f.

Ag

Rapi

d Te

st K

itaRG

19-1

1Bi

onot

e,In

c.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A6

Care

Star

t™ M

alar

ia H

RP2

(Pf)

G014

1m/G

0141

-ET

Acce

ss B

io, I

nc.

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

5Ca

reSt

art™

Mal

aria

HRP

2/pL

DH P

f tes

taG0

181m

/G01

81-E

TAc

cess

Bio

, Inc

.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A6

Core

™ M

alar

ia P

f M

AL-1

9002

0Co

re D

iagn

ostic

s10

0.0

100.

096

.710

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

3Ez

Dx™

Mal

aria

Pf R

apid

Mal

aria

ant

igen

det

ectio

n te

stRK

MAL

008

Advy

Che

mic

al P

rivat

e Li

mite

d10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A6

Firs

t Res

pons

e® M

alar

ia A

g P.

falc

ipar

um (H

RP2)

Car

d Te

stI1

3FRC

25Pr

emie

r Med

ical

Cor

pora

tion

Ltd.

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

5Fi

rst R

espo

nse®

Mal

aria

Ag

P. fa

lcip

arum

(HRP

2) C

ard

Test

PI13

FRC

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A6

Firs

tSig

n™ M

alar

ia P

f21

00CB

-25

Uni

med

Inte

rnat

iona

l Inc

.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A4

Hum

asis

Mal

aria

P.f

Antig

en T

est

ANM

PF-7

025

Hum

asis

Co.

, Ltd

.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A6

ICT

Diag

nost

ics

Mal

aria

P.f.

ML0

1IC

T In

tern

atio

nal

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

3IM

MU

NOQ

UIC

K® C

ONTA

CT fa

lcip

arum

05

19K2

5Bi

osyn

ex10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A3

IMM

UN

OQU

ICK®

MAL

ARIA

falc

ipar

um05

02_K

25Bi

osyn

ex10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A5

KHB®

Mal

aria

Ag

P.f R

apid

Tes

tKH

-R-0

6-20

Sh

angh

ai K

ehua

Bio

-eng

inee

ring

Co.,L

td.

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

5M

alar

ia A

ntig

en T

est-

PfM

AG01

040

Osca

r Med

icar

e Pv

t. Lt

d.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A6

Mal

eris

can®

Mal

aria

P.f

Antig

en T

est

MAT

-PF-

50Bh

at B

io-T

ech

Indi

a (P

te.)

Ltd.

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

4N

anoS

ign

Mal

aria

Pf A

g RM

AF10

Biol

and,

Ltd

96.7

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A3

One

Step

Mal

aria

P.F

Tes

t (Ca

sset

te)

5223

52Bl

ue C

ross

Bio

-Med

ical

(Bei

jing)

Co.

, Ltd

.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A4

One

Step

Mal

aria

P.f

Who

le b

lood

Tes

taW

37-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.10

0.0

93.3

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

6On

Site

Mal

aria

Pf A

g Ra

pid

Test

aR0

114C

CTK

Biot

ech,

Inc.

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

6Pa

rach

eck®

Pf-

Rapi

d Te

st fo

r P. f

alci

paru

m M

alar

ia D

evic

e (V

er.3

)30

2030

025

Orch

id B

iom

edic

al S

yste

ms

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

4Pa

rach

eck®

Pf-

Rapi

d Te

st fo

r P. f

alci

paru

m M

alar

ia D

ipst

ick

(Ver

.3)

3020

4002

5Or

chid

Bio

med

ical

Sys

tem

s 10

0.0

96.7

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

4Pa

raH

IT®

- f V

er. 1

(Dev

ice)

55IC

104-

50AR

KRAY

Hea

lthca

re P

vt. L

td.c

100.

096

.710

0.0

100.

010

0.0

90.0

NA

NA

NA

NA

NA

NA

3Pa

raH

IT®

- f V

er. 1

(Dip

stic

k)55

IC10

3-50

ARKR

AY H

ealth

care

Pvt

. Ltd

.c10

0.0

100.

056

.710

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

3Ra

pid

1-2-

3® H

ema®

Cas

sett

e M

alar

ia P

FMA

L-PF-C

AS/25

(100

)H

ema

Diag

nost

ic S

yste

ms

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

6Ra

piG

EN B

IOCR

EDIT

Mal

aria

Ag

Pf (H

RPII)

C10R

HA2

5Ra

piG

EN In

c.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A6

Righ

tSig

n® M

alar

ia P

.f. R

apid

Tes

t Cas

sett

e (W

hole

Blo

od)

IMPF

-C51

Han

gzho

u Bi

otes

t Bio

tech

Co.

, Ltd

.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A6

SD B

IOLI

NE

Mal

aria

Ag

P.f.

(HRP

2/pL

DH)a,

b05

FK90

Stan

dard

Dia

gnos

tics

Inc.

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

6SD

BIO

LIN

E M

alar

ia A

g Pf

05FK

50St

anda

rd D

iagn

ostic

s, In

c.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A5

Trus

ty™

Mal

aria

Ant

igen

P.f.

test

A03-

01-3

22Ar

tron

Lab

orat

orie

s In

c.10

0.0

100.

056

.710

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

4Pf

and

pan

ABON

™ P

lus

Mal

aria

P.f/

Pan

Rapi

d Te

st D

evic

e (W

hole

Blo

od)

IMA-

T402

ABON

Bio

phar

m (H

angz

hou)

Co.

Ltd

100.

010

0.0

100.

010

0.0

100.

010

0.0

0.0

0.0

0.0

0.0

0.0

0.0

4AC

CUCA

RE O

NE

STEP

MAL

ARIA

Pf/

Pan

Antig

en T

est

MAG

C 25

LAB-

CARE

Dia

gnos

tics (

Indi

a) P

VT. L

TD.

83.3

73.3

10.0

100.

010

0.0

100.

03.

310

.00.

070

.090

.030

.05

Adva

nced

Qua

lity™

Rap

id M

alar

ia T

est (

Pf/P

an)

ITP1

1005

InTe

c Pr

oduc

ts, I

nc.

86.7

96.7

100.

010

0.0

100.

010

0.0

0.0

0.0

0.0

70.0

100.

080

.05

Adva

ntag

e M

al C

ard

IR22

1025

J. M

itra

& C

o. P

vt. L

td.

0.0

0.0

0.0

100.

010

0.0

100.

00.

00.

00.

070

.010

0.0

80.0

5Ad

vant

age

Mal

aria

Pan

+ P

f Car

dIR

2310

25J.

Mitr

a &

Co.

Pvt

. Ltd

.10

0.0

100.

010

0.0

100.

010

0.0

100.

080

.093

.326

.710

0.0

100.

010

0.0

5AT

OMOR

APID

™ M

ALAR

IA (P

F/PA

N)

MM

AL01

Atom

o Di

agno

stic

s PT

Y Li

mite

d10

0.0

100.

010

0.0

100.

010

0.0

100.

00.

016

.70.

010

0.0

100.

010

0.0

6AZ

OG M

alar

ia p

f (HR

PII)/

pf (L

DH)/

(PAN

-LDH

) Ant

igen

Det

ectio

n De

viceb

MFV

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FAZ

OG, I

NC.

96.7

96.7

100.

010

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100.

010

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3.3

0.0

0.0

20.0

0.0

0.0

4BI

ONOT

E M

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IA P

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Pan

Ag

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st K

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19-0

8Bi

onot

e, In

c.10

0.0

100.

010

0.0

100.

010

0.0

100.

00.

00.

00.

010

0.0

100.

010

0.0

6

Sum

ma

ry

ro

un

dS

1-6


Prod

uct

Prod

uct

code

Man

ufac

ture

r

Perc

enta

ge p

ositi

ve t

est

resu

lts f

or P

. fal

cipa

rum

(P

f lin

e)

Perc

enta

ge p

ositi

ve t

est

resu

lts f

or P

. fal

cipa

rum

(P

f lin

e)

Perc

enta

ge p

ositi

ve t

est

resu

lts f

or P

. fal

cipa

rum

(p

an li

ne)

Perc

enta

ge p

ositi

ve t

est

resu

lts f

or P

. fal

cipa

rum

(p

an li

ne)

Roun

d20

0 pa

rasit

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00 p

aras

ites/

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0 pa

rasit

es/µ

L20

00 p

aras

ites/

µL

Base

line

35 °C

45 °C

Base

line

35 °C

45 °C

Base

line

35 °C

45 °C

Base

line

35 °C

45 °C

Num

ber

of t

ests

pos

itive

Num

ber

of t

ests

pos

itive

Num

ber

of t

ests

pos

itive

Num

ber

of t

ests

pos

itive

Lots

1 a

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com

bine

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ts 1

and

2 c

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ned

Lots

1 a

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and

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BioT

race

r™ M

alar

ia P

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N R

apid

Car

da17

012

Bio

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s Co

., Lt

d.10

0.0

100.

010

0.0

100.

010

0.0

100.

010

0.0

93.3

66.7

100.

010

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06

Care

Star

t™ M

alar

ia/P

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ancy

Com

bo (p

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cess

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Inc

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010

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100.

010

0.0

100.

010

0.0

100.

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0.0

100.

010

0.0

100.

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3Ca

reSt

art™

Mal

aria

HRP

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f/PA

N) C

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Acce

ss B

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nc.

100.

010

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96.7

100.

010

0.0

100.

093

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.753

.310

0.0

100.

010

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5Ca

reSt

art™

Mal

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pLD

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Lin

e Te

st

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.10

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100.

010

0.0

100.

010

0.0

100.

010

0.0

100.

010

0.0

100.

010

0.0

100.

03

Care

Star

t™ M

alar

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cree

n G

O231

Acce

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nc.

100.

010

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93.3

100.

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0.0

100.

010

0.0

100.

093

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0.0

100.

010

0.0

3Co

re M

alar

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an P

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4Co

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iagn

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s Lt

d.10

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100.

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0.0

100.

010

0.0

100.

026

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.083

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4di

agno

stic

ks M

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an/P

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te

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s &

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tech

Sys

tem

s10

0.0

100.

096

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100.

010

0.0

0.0

0.0

0.0

100.

090

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DIAQ

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K M

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1200

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ALAB

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100.

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0.0

0.0

0.0

0.0

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5Ez

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Mal

aria

Pan

/Pf R

apid

test

det

ectio

n Ki

taRK

MAL

001

Advy

Che

mic

al P

rivat

e Li

mite

d10

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100.

010

0.0

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03.

323

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100.

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6Fi

rst R

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pLD

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emie

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ical

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tion

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100.

010

0.0

100.

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0.0

100.

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0.0

10.0

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100.

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100.

05

Firs

t Res

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e® M

alar

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100.

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100.

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100.

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96.7

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6Fi

rstS

ign™

Par

aVie

w (P

an+P

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01CB

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med

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l Inc

.96

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0.0

100.

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0.0

100.

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0.0

0.0

0.0

13.3

100.

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100.

04

Gen

Body

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alar

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f/Pa

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100.

093

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100.

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0.0

0.0

0.0

50.0

100.

010

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Gen

edia

® M

alar

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n Ag

Rap

id T

est

20-0

146-

01Gr

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p. (K

orea

)10

0.0

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010

0.0

3.3

0.0

13.3

0.0

0.0

0.0

5H

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100.

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00.

00.

00.

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5H

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100.

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100.

010

0.0

100.

010

0.0

0.0

0.0

0.0

100.

010

0.0

100.

06

ICT

Mal

aria

Dua

l Tes

tM

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ICT

Inte

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l10

0.0

100.

010

0.0

100.

010

0.0

100.

00.

00.

00.

090

.090

.090

.05

IMM

UN

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CON

TACT

MAL

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100.

010

0.0

100.

010

0.0

100.

010

0.0

0.0

0.0

0.0

50.0

50.0

100.

03

Is It

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alar

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f/Pv

Dev

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AL03

0M

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iom

edic

als

100.

010

0.0

96.7

100.

010

0.0

100.

093

.196

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0.0

100.

090

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Mal

aria

Pan

Tes

t M

AL-W

23N

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Dim

a •

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iagn

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a m

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.310

0.0

100.

090

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Mal

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Pf./

Pan

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Inc.

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6.7

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30.

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Mal

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pf (

HRP

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(PAN

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etec

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Test

Dev

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MFV

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100.

010

0.0

100.

010

0.0

100.

010

0.0

0.0

0.0

0.0

0.0

0.0

0.0

3M

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f (H

RP II

)/PAN

(pLD

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Test

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1-13

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nite

d Bi

otec

h, In

c.

100.

096

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0.0

100.

010

0.0

16.6

0.0

0.0

90.0

40.0

50.0

4M

alar

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f (pL

DH) /

PAN

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H T

est D

evic

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FV-1

24AZ

OG, I

nc.

46.7

56.7

66.7

100.

010

0.0

100.

013

.393

.310

0.0

60.0

100.

010

0.0

5M

alar

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ANG

M00

4Ge

nom

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olec

ular

Dia

gnos

tics P

vt.Lt

d.56

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0.0

100.

010

0.0

0.0

0.0

0.0

60.0

90.0

50.0

4M

alar

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f/Pa

n On

e St

ep R

apid

Tes

tRT

202

22Zh

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ng O

rient

Gen

e Bi

otec

h Co

., Ltd

.10

0.0

100.

096

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0.0

90.0

100.

00.

00.

00.

010

0.0

90.0

100.

05

Mal

asca

n™ D

evic

e -

Rapi

d te

st fo

r Mal

aria

Pf/

Pan

5040

2025

Zeph

yr B

iom

edic

al S

yste

ms

96.7

100.

096

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0.0

100.

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0.0

0.0

0.0

6.7

100.

010

0.0

100.

03

MeD

iPro

Mal

aria

Ag

HRP

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DH C

ombo

IR-0

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Form

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Biom

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chno

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Cor

p.10

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96.7

96.7

100.

010

0.0

100.

00.

00.

00.

00.

00.

00.

04

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

-01

Mer

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agno

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s Pr

ivat

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d.10

0.0

100.

010

0.0

100.

010

0.0

100.

046

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010

0.0

100.

010

0.0

6N

anoS

ign

Mal

aria

pf/

pan

Ag 3

.0RM

AP10

Biol

and

Ltd.

100.

010

0.0

100.

010

0.0

100.

010

0.0

0.0

0.0

0.0

100.

010

0.0

100.

04

Nan

oSig

n M

alar

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f/Pv

Ag

RMAD

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td0.

00.

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020

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00.

00.

00.

00.

00.

00.

00.

03

NG

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t MAL

ARIA

Pf/

Pan

(pLD

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NG-M

AL-W

23-0

01SA

RL N

G B

iote

ch, Z

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100.

010

0.0

100.

010

0.0

100.

010

0.0

0.0

6.7

0.0

100.

010

0.0

100.

05

One

Step

Mal

aria

P.f/

Pan

Test

W56

-CG

uang

zhou

Won

dfo

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ech

Co. L

td.

46.7

13.3

26.7

100.

010

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100.

00.

036

.773

.370

.080

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3On

e St

ep M

alar

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n W

hole

Blo

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est

W62

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100.

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96.7

100.

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100.

00.

00.

00.

090

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0.0

70.0

6On

Site

Mal

aria

Pf/

Pan

Ag R

apid

Tes

taR0

113C

CTK

Biot

ech,

Inc.

100.

010

0.0

100.

010

0.0

100.

010

0.0

0.0

6.7

0.0

100.

010

0.0

100.

06

OptiM

AL-I

T 71

0024

Diam

ed -

A D

ivis

ion

of B

io-R

ad0.

00.

00.

010

0.0

90.0

0.0

0.0

0.0

0.0

100.

090

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03

Para

HIT

- T

otal

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. 1.0

(Dev

ice)

55IC

204-

10Sp

an D

iagn

ostic

s Lt

d.10

0.0

100.

010

0.0

100.

010

0.0

100.

00.

00.

00.

010

0.0

100.

010

0.0

4Pa

raH

IT -

Tot

al V

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.0 (D

ipst

ick)

55IC

203-

10Sp

an D

iagn

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s Lt

d.10

0.0

93.3

46.7

100.

010

0.0

60.0

50.0

0.0

0.0

100.

090

.00.

04

Para

scre

en®

- Ra

pid

test

for M

alar

ia P

an/P

fa50

3030

025

Zeph

yr B

iom

edic

als

100.

010

0.0

100.

010

0.0

100.

010

0.0

100.

090

.093

.310

0.0

100.

010

0.0

6Qu

ickP

rofil

e™ M

alar

ia P

f/Pa

n Te

st71

063

Lum

iqui

ck D

iagn

ostic

s, In

c.10

0.0

100.

010

0.0

100.

010

0.0

100.

010

0.0

96.7

100.

010

0.0

100.

010

0.0

6Ra

piG

EN B

IOCR

EDIT

Mal

aria

Ag

Pf/P

an (H

RPII/

pLDH

)aC3

0RH

A25

Rapi

GEN

Inc.

100.

010

0.0

96.7

100.

010

0.0

100.

00.

010

.026

.710

0.0

100.

010

0.0

6Ri

ghtS

ign™

Mal

aria

P.f.

/Pan

Rap

id T

est C

asse

tte

IMPN

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Han

gzho

u Bi

otes

t Bio

tech

Co.

Ltd

.10

0.0

100.

010

0.0

100.

010

0.0

100.

00.

020

.010

0.0

100.

060

.010

0.0

5

Tabl

e S3

(con

tinue

d)

(con

tinue

d)


Prod

uct

Prod

uct

code

Man

ufac

ture

r

Perc

enta

ge p

ositi

ve t

est

resu

lts f

or P

. fal

cipa

rum

(P

f lin

e)

P erc

enta

ge p

ositi

ve t

est

resu

lts f

or P

. fal

cipa

rum

(P

f lin

e)

P erc

enta

ge p

ositi

ve t

est

resu

lts f

or P

. fal

cipa

rum

(p

an li

ne)

P erc

enta

ge p

ositi

ve t

est

resu

lts f

or P

. fal

cipa

rum

(p

an li

ne)

Roun

d20

0 pa

rasit

es/µ

L20

00 p

aras

ites/

µL20

0 pa

rasit

es/µ

L20

00 p

aras

ites/

µL

Base

line

35 °C

45 °C

Base

line

35 °C

45 °C

Base

line

35 °C

45 °C

Base

line

35 °C

45 °C

Num

ber

of t

ests

pos

itive

Num

ber

of t

ests

pos

itive

Num

ber

of t

ests

pos

itive

Num

ber

of t

ests

pos

itive

Lots

1 a

nd 2

com

bine

dLo

ts 1

and

2 c

ombi

ned

Lots

1 a

nd 2

com

bine

dLo

ts 1

and

2 c

ombi

ned

SD B

IOLI

NE

Mal

aria

Ag

P.f/

Pan

05FK

60St

anda

rd D

iagn

ostic

s In

c.10

0.0

100.

010

0.0

100.

010

0.0

100.

00.

00.

00.

010

0.0

100.

010

0.0

5SD

BIO

LIN

E M

alar

ia A

g Pf

/ Pan

05FK

66St

anda

rd D

iagn

ostic

s In

c.

96.7

96.7

100.

090

.010

0.0

100.

016

.610

.00.

090

.010

0.0

100.

04

SD B

IOLI

NE

Mal

aria

Ag

05FK

40St

anda

rd D

iagn

ostic

s In

c.0.

00.

00.

010

0.0

80.0

90.0

0.0

0.0

0.0

80.0

20.0

90.0

3Vi

kia®

Mal

aria

Ag

Pf/P

an41

2499

IMAC

CESS

S.A

.S10

0.0

96.7

96.7

100.

010

0.0

100.

00.

00.

00.

060

.060

.00.

05

Pf a

nd P

v/Pv

omAd

vanc

ed Q

ualit

y™ O

ne St

ep M

alar

ia (P

f/Pv)

Tri-L

ine T

est (

who

le bl

ood)

a IT

P110

03 T

C40

InTe

c Pr

oduc

ts, I

nc.

96.7

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A6

Adva

ntag

e M

alar

ia C

ard

IR21

1025

J. M

itra

& C

o. P

vt. L

td.

100.

096

.796

.710

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

3AS

AN E

asy

Test

® M

alar

ia P

f/Pa

n Ag

AM46

50-K

ASAN

Pha

rmac

eutic

al C

o., L

td

100.

096

.763

.310

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

5BI

ONOT

E M

ALAR

IA P

.f.&

P.v.

Ag

Rapi

d Te

st K

it RG

19-1

2Bi

onot

e,In

c.10

0.0

96.7

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

3Bi

oTra

cer™

Mal

aria

P.f/

P.v

Rapi

d Ca

rd17

412

Bio

Focu

s Co

., Lt

d.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A6

Care

Star

t Mal

aria

HRP

2/pL

DH (P

f/Pv

) COM

BOG0

161m

/G01

61-E

TAc

cess

Bio

, Inc

.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A4

Care

Star

t Mal

aria

HRP

2/pL

DH (P

f/VO

M) C

OMBO

G017

1/G0

171-

ETAc

cess

Bio

, Inc

.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A4

Core

™ M

alar

ia P

v/Pf

MAL

-190

022

Core

Dia

gnos

tics

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

3Co

rete

sts®

One

Ste

p M

alar

ia P

f/Pv

Ag

Test

Dev

ice

B42-

21/B

42-2

2Co

re T

echn

olog

y Co

., Lt

d.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A6

EzDx

™ M

alar

ia P

v/Pf

Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

03Ad

vy C

hem

ical

Priv

ate

Lim

ited

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

6Fa

lciV

ax™

- R

apid

Tes

t for

Mal

aria

Pv/

Pfa

5030

1002

5Ze

phyr

Bio

med

ical

s10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A6

Firs

t Res

pons

e® M

alar

ia A

g Pf

/Pv

Card

Tes

tPI

19FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

6H

iSen

s M

alar

ia A

g P.

f/P.

v Co

mbo

Car

dH

R312

3H

BI C

o., L

td.

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

4H

iSen

s M

alar

ia A

g P.

f/VO

M C

ombo

Car

dH

R332

3H

BI C

o., L

td.

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

4H

umas

is M

alar

ia P

.f/P.

v An

tigen

Tes

tAM

FV-7

025

Hum

asis,

Co.

, Ltd

.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A4

Hum

asis

Mal

aria

P.f/

P.v

Antig

en T

est

ANM

IV-7

025

Hum

asis,

Co.

, Ltd

.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A6

KHB®

Mal

aria

Ag

P.f/

P.v

Rapi

d Te

stKH

-R-0

7-50

Shan

ghai

Keh

ua B

io-e

ngin

eerin

g Co

., Ltd

.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A6

Mal

aria

pf (

HRP

II) /

pv

(pLD

H) A

ntig

en D

etec

tion

Test

Dev

ice

1-13

-101

-3U

nite

d Bi

otec

h, In

c.

100.

010

0.0

100.

090

.010

0.0

100.

0N

AN

AN

AN

AN

AN

A4

Mal

aria

pf (

HRP

II) /

pv

(pLD

H) A

ntig

en D

etec

tion

Test

Dev

ice

MFV

-124

VAZ

OG, I

nc.

100.

010

0.0

96.7

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A3

Mal

aria

Pf (

HRP

II)/ P

V (p

LDH

) Ant

igen

Det

ectio

n Te

st D

evic

e G

M00

6Ge

nom

ix M

olec

ular

Dia

gnos

tics P

vt. L

td.

83.3

90.0

83.3

100.

090

.070

.0N

AN

AN

AN

AN

AN

A5

Mal

aria

Pf/

PvG

M00

2Ge

nom

ix M

olec

ular

Dia

gnos

tics P

vt.Lt

d.40

.033

.340

.010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

4M

alar

ia P

V/PF

(pLD

H/H

RP2)

Ant

igen

Tes

t In

f-72

Nan

tong

Ege

ns B

iote

chno

logy

Co.

, Ltd

.10

0.0

100.

096

.610

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

6M

aler

isca

n® M

alar

ia P

f/PA

N (P

v, Pm

, Po)

3 L

ine

Antig

en T

est

MAT

-PF/

PAN

-50

Bhat

Bio

-Tec

h In

dia

(P) L

td.

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

5M

eris

cree

n M

alar

ia P

f/Pv

Ag

MFL

RPD-

01M

eril

Diag

nost

ics

Priv

ate

Ltd.

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

6On

e St

ep M

alar

ia P

.F/P

.V T

est (

Cass

ette

)52

3352

Blue

Cro

ss B

io-M

edic

al (B

eijin

g) C

o., L

td.

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

5On

e St

ep M

alar

ia P

.f/P.

v W

hole

Blo

od T

esta

W05

6-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A6

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

d Te

sta

R011

2CCT

K Bi

otec

h, In

c.10

0.0

100.

090

.010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

6Pa

raHI

T®fV

Rap

id te

st fo

r P. f

alcip

arum

and

P. v

ivax

Mal

aria

- De

vice

55IC

402-

50Sp

an D

iagn

ostic

s Lt

d.10

0.0

96.7

96.7

100.

010

0.0

90.0

NA

NA

NA

NA

NA

NA

5Qu

ickP

rofil

e™ M

alar

ia P

f/Pv

Tes

t71

050

Lum

iqui

ck D

iagn

ostic

s, In

c.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A6

RAPI

D 1-

2-3®

HEM

A CA

SSET

TE M

ALAR

IA P

F/PV

TES

TMA

L-PFV

-CAS

/25(10

0)H

ema

Diag

nost

ic S

yste

ms,

LLC

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

4Ra

piG

EN B

IOCR

EDIT

Mal

aria

Ag

Pf/P

v (H

RPII/

pLDH

)C4

0RH

A25

Rapi

GEN

Inc.

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

6SD

Bio

line

Mal

aria

Ag

P.f/

P.va

05FK

80St

anda

rd D

iagn

ostic

s, In

c.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A6

Trus

ty™

Mal

aria

Ant

igen

P.f.

/p.v.

test

A03-

12-3

22Ar

tron

Lab

orat

orie

s In

c.10

0.0

100.

036

.710

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

4Pf

, Pf

and

PvSD

Bio

line

Mal

aria

Ag

P.f/

P.f/

P.vb

05FK

120

Stan

dard

Dia

gnos

tics,

Inc.

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

6Pf

, Pv

and

pan

Core

™ M

alar

ia P

an/P

v/Pf

M

AL-1

9002

6Co

re D

iagn

ostic

s10

0.0

100.

010

0.0

100.

090

.010

0.0

0.0

0.0

0.0

80.0

50.0

70.0

3di

agno

stic

ks M

ALAR

IA (P

an/P

v/Pf

) Cas

sett

eM

PNVF

C100

7.5

SSA

Diag

nost

ics

& B

iote

ch S

yste

ms

96.7

100.

093

.310

0.0

100.

010

0.0

0.0

0.0

0.0

70.0

0.0

50.0

3

Tabl

e S3

: Mal

aria

RDT

rou

nds

3–6

heat

sta

bilit

y re

sult

s on

a c

ultu

red

P. fa

lcip

arum

sam

ple

at lo

w (2

00)

and

high

(200

0) p

aras

ite

dens

ity

(par

asit

es/μ

L).

Posi

tivi

ty r

ate

at b

asel

ine

(roo

m t

empe

ratu

re)

and

afte

r 60

day

s’ in

cuba

tion

at 3

5 °C

and

45

°C (c

ontin

ued)

Sum

ma

ry

ro

un

dS

1-6


Prod

uct

Prod

uct

code

Man

ufac

ture

r

Perc

enta

ge p

ositi

ve t

est

resu

lts f

or P

. fal

cipa

rum

(P

f lin

e)

Perc

enta

ge p

ositi

ve t

est

resu

lts f

or P

. fal

cipa

rum

(P

f lin

e)

Perc

enta

ge p

ositi

ve t

est

resu

lts f

or P

. fal

cipa

rum

(p

an li

ne)

Perc

enta

ge p

ositi

ve t

est

resu

lts f

or P

. fal

cipa

rum

(p

an li

ne)

Roun

d20

0 pa

rasit

es/µ

L20

00 p

aras

ites/

µL20

0 pa

rasit

es/µ

L20

00 p

aras

ites/

µL

Base

line

35 °C

45 °C

Base

line

35 °C

45 °C

Base

line

35 °C

45 °C

Base

line

35 °C

45 °C

Num

ber

of t

ests

pos

itive

Num

ber

of t

ests

pos

itive

Num

ber

of t

ests

pos

itive

Num

ber

of t

ests

pos

itive

Lots

1 a

nd 2

com

bine

dLo

ts 1

and

2 c

ombi

ned

Lots

1 a

nd 2

com

bine

dLo

ts 1

and

2 c

ombi

ned

Pan

only

Adva

ntag

e Pa

n M

alar

ia C

ard

IR01

3025

J. M

itra

& C

o. P

vt. L

td.

NA

NA

NA

NA

NA

NA

36.7

66.7

60.0

100.

010

0.0

90.0

5AZ

OG h

CG M

alar

ia D

etec

tion

Test

Dev

ice

MPT

-124

AZOG

, IN

C.N

AN

AN

AN

AN

AN

A10

0.0

100.

010

0.0

100.

010

0.0

100.

04

Care

Star

t™ M

alar

ia p

LDH

(PAN

)G

0111

Acce

ss B

io, I

nc.

NA

NA

NA

NA

NA

NA

100.

010

0.0

100.

010

0.0

100.

010

0.0

5di

agno

stic

ks M

ALAR

IA (P

an) C

asse

tte

MPN

WBC

1007

.3SS

A Di

agno

stic

s &

Bio

tech

Sys

tem

sN

AN

AN

AN

AN

AN

A0.

00.

00.

080

.010

0.0

80.0

3Pa

raba

nk™

Dev

ice

- Ra

pid

test

for M

alar

ia P

an50

3010

25Ze

phyr

Bio

med

ical

Sys

tem

sN

AN

AN

AN

AN

AN

A0.

00.

00.

090

.010

0.0

100.

03

NA,

not

app

licab

lePf

, Pla

smod

ium

falc

ipar

um

Pv,

Plas

mod

ium

viv

ax

pan

, Pla

smod

ium

spec

ies

Pvo

m, P

lasm

odiu

m v

ivax

, ova

le a

nd m

alar

iae

Indi

cate

s re

sults

for t

hose

pro

duct

s th

at m

eet a

ll W

HO

reco

mm

ende

d pr

ocur

emen

t crit

eria

a Pr

oduc

t res

ubm

issi

on, r

esul

ts fr

om m

ost r

ecen

t rou

nd o

f tes

ting

repl

ace

prev

ious

resu

lts. R

efer

to T

able

S1.

b

Resu

lts p

rese

nted

in th

e ta

ble

are

base

d on

sta

bilit

y of

a P

f tes

t lin

e (e

ither

Pf-

HRP

2 or

Pf-

pLDH

). Re

sults

bas

ed o

n st

abili

ty o

f ind

ivid

ual t

est l

ines

is p

rese

nted

in th

e fo

llow

ing

tabl

e:

c S

pan

Diag

nost

ics

Ltd.

is n

ow A

RKRA

Y H

ealth

care

Pvt

. Ltd

.

Prod

uct

Prod

uct

co

deM

anuf

actu

rer

Perc

enta

ge p

ositi

ve t

est

resu

lts

for

P. f

alci

paru

m (P

f lin

e)Pe

rcen

tage

pos

itive

tes

t re

sults

fo

r P.

fal

cipa

rum

(Pf l

ine)

Perc

enta

ge p

ositi

ve t

est

resu

lts

for

P. f

alci

paru

m (p

an li

ne)

Perc

enta

ge p

ositi

ve t

est

resu

lts

for

P. f

alci

paru

m (p

an li

ne)

Roun

d20

0 pa

rasit

es/µ

L20

00 p

aras

ites/

µL20

0 pa

rasit

es/µ

L20

00 p

aras

ites/

µLBa

selin

e35

°C45

°CBa

selin

e35

°C45

°CBa

selin

e35

°C45

°CBa

selin

e35

°C45

°CN

umbe

r of

tes

ts p

ositi

veN

umbe

r of

tes

ts p

ositi

veN

umbe

r of

tes

ts p

ositi

veN

umbe

r of

tes

ts p

ositi

veLo

ts 1

and

2 c

ombi

ned

Lots

1 a

nd 2

com

bine

dLo

ts 1

and

2 c

ombi

ned

Lots

1 a

nd 2

com

bine

dSD

Bio

line

Mal

aria

Ag

P.f/

P.f/

P.v

- (P

F(H

RP2)

line

)05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.10

0.0

100.

010

0.0

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A6

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v -

(PF(

pLDH

) lin

e)05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.30

.030

.030

.010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

6SD

BIO

LIN

E M

alar

ia A

g P.

f. (H

RP2/

pLDH

) - (P

F(H

RP2)

line

)05

FK90

Stan

dard

Dia

gnos

tics,

Inc.

100.

010

0.0

100.

010

0.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

6SD

BIO

LIN

E M

alar

ia A

g P.

f. (H

RP2/

pLDH

)- (P

F(pL

DH) l

ine)

05

FK90

Stan

dard

Dia

gnos

tics,

Inc.

93.3

90.0

66.7

100.

010

0.0

100.

0N

AN

AN

AN

AN

AN

A6

AZOG

Mal

aria

pf (

HRP

II)/p

f (LD

H)/

(PAN

-LDH

) Ant

igen

De

tect

ion

Devi

ce -

(PF(

HRP

2) li

ne)

MFV

-124

FAZ

OG, I

NC.

96.7

96.7

100.

010

0.0

100.

010

0.0

3.3

0.0

0.0

20.0

0.0

0.0

4

AZOG

Mal

aria

pf (

HRP

II)/p

f (LD

H)/

(PAN

-LDH

) Ant

igen

De

tect

ion

Devi

ce -

(PF(

pLDH

) lin

e)M

FV-1

24F

AZOG

, IN

C.13

.33.

36.

750

.010

.050

.03.

30.

00.

020

.00.

00.

04

Tabl

e S3

(con

tinue

d)


Table S4: Products evaluated during rounds 1-6 that have been removed from summary results listings

Manufacturer Product Product code

Amgenix International, Inc.

OnSight™ - Malaria Pf Test 511-25-DBOnSight™ - ParaQuick-2 (Pv,Pf) Malaria Test 537-25-DBOnSight™ - PanScreen (Pan) Malaria Test 539-25-DBOnSight™ - ParaQuick (Pan, Pf) Test 536-25-DB

Abon Biopharm (Hangzhou) Co. Ltd. (Iverness Medical) ABON Malaria Pan/P.f.Rapid Test Device (whole blood) IMA-B402

Access Bio EthiopiaParaCare Malaria HRP2/pLDH (Pf/Pv) COMBO G0161ParaCare Malaria HRP2/pLDH (Pf/VOM) COMBO G0171

ACON Biotech (Hangzhou) Co. Ltd Surestep™ Malaria Pf/Pan Rapid Test Device (Whole Blood) IMA-T402

Acon Laboratories, Inc Malaria Plasmodium falciparum Rapid Test Device (Whole Blood) IMA-402

Bhat Bio-Tech India (P) Ltd Maleriscan® Malaria Pf/Pv MAT-50Biosynex Immunoquick Malaria +4 0506_K25Diagnostics Automation/Cortez Diagnostics Inc. Malaria P.F/Vivax 172110P-25

HBI Co., Ltd.HiSens Malaria Ag P.f/P.v Card HR2823HiSens Malaria Ag Pf/Pv (HRP2/pLDH) Card HR2923HiSens Malaria Ag Pf HRP2 Card HR3023

Human GmbHHexagon Malaria 58051Hexagon Malaria Combi 58024

ICT INTERNATIONALICT Malaria Combo ML02ICT MALARIA P.F. ML04

IND Diagnostic Inc.One Step Malaria Antigen Strip 820-1IND ONE STEP MALARIA ANTIGEN P.f/Pan TEST 535-10IND ONE STEP MALARIA ANTIGEN P.f 535-11

Innovatek Medical Inc. Quickstick Malaria Antigen TestInverness Medical Innovations, Inc. Binax Now Malaria IN660050Medical Diagnostech (Pty) Ltd MD Malaria Pf/Pan (pLDH) test MDMALLDH001

Medisensor, Inc.Medisensor Malaria HRP2/pLDH (Pf/Pv) COMBO M161Medisensor Malaria HRP2/pLDH (Pf/VOM) COMBO M171

Orgenics Ltd. (Inverness Innovations) Clearview® Malaria pLDH 70884025Orgenics Ltd.(IS) Clearview® Malaria Dual VB20Premier Medical Corporation Ltd. First Response® Malaria Ag pLDH I12FRC30RapiGen inc. BIOCREDIT Malaria pf(HRP II) HR0100

Span Diagnostics

ParaHIT®-f Dipstick 55IC101-50/25977ParaHIT®- f Device 55IC102-50/25975ParaHIT - Total (Device) 55IC202-10/25989ParaHIT Pan M (dipstick) 55IC301-10ParaHIT total (dipstick) 55IC201-10/25988

SSA Diagnostics & Biotech Systemsdiagnosticks- Malaria (Pf) Cassette KMFC6001diagnosticks- Malaria (Pf) Dipstick KMFD6007diagnosticks- Malaria (Pv/Pf) Cassette KMVFC6002

Standard Diagnostics Inc.

SD BIOLINE Malaria Ag Pf/ Pf/ Pv 05FK100SD BIOLINE Malaria Ag Pv 05FK70SD BIOLINE Malaria Ag P.f/Pan 05FK63a

SD Bioline Malaria Ag P.f/P.v 05FK83b

SD BIOLINE Malaria Ag Pf 05FK53c

Unimed International

FirstSign – Malaria Pf Card Test -FirstSign – ParaView-2 (Pv + Pf) Card Test 2102CB-25FirstSign™ - PanCheck (Pan) Malaria Test 2104 CB-25FirstSign™ - ParaView-3 (Pan+Pv+Pf) Malaria Test 2103 CB-25

Vision Biotech (Pty) LtdVision Malaria Pf VB01Clearview® Malaria Combo VB11

Zephyr Biomedicals Paramax-3 Rapid Test for Malaria Pan/Pv/Pf (device) 50320025

Pf, P. falciparum Pv, P. vivax Pvom, P. vivax, ovale, malariae HRP2, histidine-rich protein 2 pLDH, Plasmodium lactate dehydrogenase

a Previously co-listed with 05FK60 (multi-use pack), but removed because single pack format (05FK63) not evaluated at CDC b Previously co-listed with 05FK80 (multi-use pack), but removed because single pack format (05FK83) not evaluated at CDCc Previously co-listed with 05FK50 (multi-use pack), but removed because single pack format (05FK53) not evaluated at CDC

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2120 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 6 (2014–2015)

2. eXecutIve summAry

2.1. IntroductionWHO estimates that 3.2 billion people are at risk for malaria. In 2014, there were an estimated 214 million cases (with an uncertainty range of 149 million to 303 million) and an estimated 438 000 deaths (with an uncertainty range of 236 000 to 635 000). Approximately 90% of all malaria deaths occur in sub-Saharan Africa, and nearly 70% occur in children under 5 years. Malaria remains endemic in 97 countries, and, while parasite-based diagnosis is increasing, approximately 35% of suspected malaria cases in Africa were not confirmed with a diagnostic test during 2014, resulting in over-use of antimalarial drugs and poor disease monitoring (1).

WHO recommends that malaria case management be based on parasite diagnosis in all cases (2). The use of antigen-detecting RDTs is a vital part of this strategy, forming the basis for extending access to malaria diagnosis by providing parasite-based diagnosis in areas where good-quality micros-copy cannot be maintained. The data generated by the WHO and FIND programme to evaluate and compare the performance of commercially available malaria RDTs are guiding procurement decisions, which, in turn, have shifted markets towards better-performing tests and helped to improve the quality of manufacture. The results of WHO malaria RDT product testing form the basis for procurement criteria and constitute the laboratory evaluation component of WHO prequalification for malaria RDTs. This report provides the results of round 6 of product testing, performed at the CDC during 2014–2015, with data on the performance of 41 products. This round adds to the evaluations of rounds 1–5 (3–7), which should be considered as a single evaluation, except that the results for products tested in previous rounds that were resubmitted for testing replace those reported previously. From round to round, the evaluation panels are essentially the same (Annex S1), and the same or slightly modified testing protocols are followed. This report extends the data from previous rounds and therefore increases the number of RDTs available for procurement for which detailed, comparative data are available on aspects of performance relevant to field use. The report provides updated data on the performance of products at least every 5 years, as a result of implementation of the compulsory resubmission policy.

2.2. the wHo product testing programmeProduct testing is part of the WHO–FIND malaria RDT evalu-ation programme, which develops methods for evaluation and provides data on antigen-detecting malaria RDTs. The programme is a collaboration among many institutions in

malaria-endemic and non-endemic countries, with a global specimen bank and testing performed at the CDC (Fig. 2).

All companies that manufacture according to ISO 13485:2003 quality system standards were invited to submit tests for evaluation in the programme. The 41 products from 22 manufacturers were evaluated with prepared blood panels of cultured P. falciparum parasites, patient-derived wild-type P. falciparum and P. vivax parasites and a parasite-negative panel. Observed anomalies were recorded. Thermal stability was assessed after 2 months of storage at elevated tempera-ture and humidity, and a rudimentary assessment of ease of use was recorded. As in previous rounds, RDTs are grouped in the tables and figures into those designed to detect P. falciparum only, various combination tests and those that have a line only for pan-specific (or P. vivax-specific) malaria. Manufacturers submitted two lots of each product for evaluation. The 16 products that had been tested in previous rounds comprised two compulsory resubmissions and 14 voluntary resubmissions (Tables 1a,b).

The aim of the evaluation is to provide comparative data on the performance of the submitted production lots of each product against samples containing low (200 parasites/µL) and high densities (2000 or 5000 parasites/µL) of P. falci-parum or P. vivax. Because the concentration of target antigens in samples with the same parasite density is variable, the process for selecting the panel is adjusted to ensure that there is no statistically significant difference in mean or median concentrations of HRP2, aldolase and pLDH antigens between panels used in different rounds of testing (Annex S1, Table 3).

The data in this report are used to guide procurement decisions by WHO, other United Nations agencies and national govern-ments. Product testing is part of a continuing programme to improve the quality of RDTs that are used and to support widespread, reliable malaria diagnosis in areas where malaria is prevalent. A seventh round of product testing began in November 2015, and the results will be published in 2017.

Compulsory resubmission was introduced in round 5. Manufacturers who do not submit products that are due for resubmission (every five years) are removed from the summary results (Tables S2 and S3) and the online interactive database, and are only featured in the full round-specific product testing report. These products will not be eligible for WHO procurement. A product is also delisted if WHO is notified by the manufacturer that its production has been discontinued.


2.3. results of the evaluation The results (summarized in Tables 4 and 5 and Figs 9, 10, 11, 14 and 15) provide a comparison of two lots of products against a panel of parasite samples diluted to a low parasite density (200 parasites/µL), considered to be close to the threshold that tests must detect in order to reliably identify clinical malaria in many settings (10), and a higher parasite density (2000 or 5000 parasites/µL).

For the purposes of this report, the main measure of perfor-mance is the PDS, the percentage of malaria samples in a panel that give a positive result in two RDTs per lot at the lower parasite density and a single RDT per lot at the higher parasite density. Thus, it is not a measure of clinical sensitivity or of the positivity rate against the panel but rather a combined measure of positivity rate and inter-test and inter-lot consistency.

As for products evaluated in previous rounds of product testing, the PDS varied, although much less variation was seen for P. falciparum-only detecting RDTs in round 6. Generally, products with high performance in detecting parasites have low false-positive rates, good thermal stability and low rates of anomalies. Overall, there is no obvious trade-off between the PDS (or positivity rate) and the false-positive rate, which are surrogates for sensitivity and specificity in the field, respectively.

The basis for P. falciparum detection by combination RDTs (P. falciparum/pan, P. falciparum/P. vivax, P. falciparum/P. vivax, ovale and malariae or P. falciparum/P. falciparum/P. vivax), particularly in samples with low parasite density, is predomi-nantly detection of HRP2 and not pLDH. In other words, it is mainly the HRP2 test band that reacts with P. falciparum-containing samples, probably reflecting poorer affinity of the monoclonal pLDH antibodies on the pLDH test band and not HRP2-persistent antigenaemia, as all samples are known to contain P. falciparum (and pLDH). Therefore, when using HRP2 and pan-pLDH (or Pf-pLDH) combination products in the field, it is important to remember that the presence of an HRP2 band combined with the absence of a pLDH band may reflect the lower sensitivity of the pLDH-detecting band in low-density samples and not persistent antigenaemia or successful treatment.

In round 6, the results for both of the retested products were within 7% of the initial test for detection of P. falciparum and P. vivax at 200 parasites/µL. Most of the differences detected were decreases in PDS performance and improvements in false-positivity rates, in comparison with previous testing. Among the voluntary resubmissions, 29% (4/14) and 60% (6/10) of products showed the same or better detection of P. falciparum and P. vivax at 200 parasites/µL, respectively. However, detection of P. falciparum decreased by 6% on average, while the mean improvement in P. vivax detection was 9%. In combination tests, there was no significant correlation between the change in P. falciparum and P. vivax detection (p = 0.7), suggesting that changes in detection of these two parasite species occurred independently.

In round 6, no products had very high false-positive rates when tested against clean negatives, which was an improvement on the high rates observed in rounds 4 and 5. Similarly, while some products did react against blood samples containing specific immunological abnormalities (and against samples containing non-Plasmodium infectious agents), these false-positive rates were much lower than that seen in round 5 (Tables A4.6–A4.9). The number of samples evaluated was, however, small, and the clinical significance of these results is limited, although they may be important in certain populations with very low parasite prevalence.

There was no notable lot variation in round-6 products (Table A4.1); however, as previous rounds have shown variation in performance between the two lots evaluated, it is still recommended that products be lot-tested before field use.

The majority of products showed good heat (thermal) stability on the P. falciparum HRP2 test lines after 2 months’ storage at 45 °C and 75% humidity. However, Pf-pLDH test lines showed variable baseline performance and deterioration after incubation at 45 °C. For many products, pan-pLDH perfor-mance at baseline and post-heat stress for detection of the P. falciparum isolate was poor, and it was nearly universally poor against low-parasite-density samples, making it difficult to assess true stability. This round included the first heat stability assessment against a wild-type P. vivax sample. While some products performed well, with high positivity after 2 months’ storage at 45 °C and 75% humidity, others performed poorly at baseline when detecting pan-pLDH and P. vivax pLDH, so that it was difficult to evaluate true stability after incubation. Overall, the pan-pLDH line was more heat stable than the P. vivax pLDH line when tested against the P. vivax sample.

All products showed at least one anomaly, with some having up to six different types of anomaly that could interfere with test interpretation. The frequency of each anomaly was recorded for the first time in round 6. Incomplete clearing and a red background were the most commonly observed anomalies, seen in 95% and 85% of products, respectively (Table 8). Cases of failed migration, incomplete migration and patchy broken test lines were reported the next most regularly, in 34%, 32% and 37% of products, respectively. Overall, approximately half the products had a frequency of anomalies > 2% (Fig. 30).

The clinical sensitivity of an RDT, i.e. the proportion of known cases of the disease with a positive test, is highly dependent on local conditions, including the parasite density in the target population; it therefore varies in populations with different levels of transmission. The comparative performance between RDTs shown in this report give an indication of which products are likely to be more sensitive in the field, particularly for populations with low-density infections. In general, as the malaria prevalence in countries falls and they even move towards malaria elimination, detection of low parasite densities will become increasingly important in case management. As the PDS at 2000 parasites/µL indicates, the sensitivity of many of these products will be similar in

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populations with higher parasite densities, although a subset of any population will include vulnerable individuals who may develop illness at low parasite densities (e.g. young children, pregnant women, people well protected by bed nets) and must always be taken into account when interpreting RDT results. For areas where significant non-expression of HRP2 is known, the results in this report for HRP2-detecting tests should not be considered to predict sensitivity in the field. Only tests targeting P. falciparum by detection of pLDH or aldolase should be considered.

Heat stability (summarized in Tables 6a and 6b) is vital to maintaining the sensitivity of a test in the field. For procure-ment, therefore, the stability results should be used to ensure that products to be used in areas with high temperatures during transport and storage have demonstrated good stability in the product testing programme. The requirements vary by country; for example, if tests are to be used in areas where the temperature rarely rises above 30 °C, stability at high temperatures is less important.

The requirements for ease of use depend on the extent of training and the work environment of users. Particularly in primary health care settings, the simpler the test, the easier it should be to avoid errors in preparation and interpretation.

2.4. use of the resultsBox 3 outlines WHO’s minimum criteria for selecting RDTs, and the results in Tables S2, S3 and 5 are colour-coded to reflect achievement of these requirements, as well as WHO prequalification status (indicated in Table S2). A web-based tool maintained by FIND allows filtering of product testing results by various parameters to assist in selecting products with the performance characteristics most suitable for a country’s health programme (13). This online database has been updated to allow filtering of results by RDT procedural characteristics, such as blood volume requirements, number of buffer drops and time to result. This grouping, also indicated in Annex 1, will allow use of the same or similar protocols to identify products, so that, when product replacement is required, another product with the same or similar protocol may be selected. Use of similar products may reduce the need for user retraining and also reduce user error.

Annex S3 provides a step-by-step approach to selecting an RDT, taking into consideration local conditions of malaria transmission and illness (e.g. Plasmodium spp., target antigen, parasite density, climate) and other important considerations, including ease of use in the field and lot testing. RDTs must not be procured without preparation for proper use, including supply chain management and training in test use and disposal and in patient management in response to results. Comprehensive guidance on several aspects of procurement can be found in Good practices for selecting and procuring rapid diagnostic tests for malaria (14) and guidance on implementation in Universal access to malaria diagnosis (15).


3. bAckground

During the past decade, new opportunities for the control of malaria have emerged, including use of long-lasting insecticidal nets, indoor residual spraying of insecticides and artemisinin-based combination therapy. These have been shown to reduce the burden of malaria infection in countries where they are adequately implemented. Therefore, the proportion of febrile episodes attributable to malaria is likely to decrease substantially.

Despite WHO’s recommendation for a parasitologically confirmed diagnosis of malaria infection before treatment in all cases (2), diagnoses are still often made on clinical grounds (10); however, in most endemic areas, malaria accounts for a minority of cases of “malaria-like” febrile illness. Microscopy has been the cornerstone of diagnosis and is recommended for malaria diagnosis when its quality can be maintained; however, the need for trained personnel and adequate reagents and equipment limits its availability and accessibility in malaria-endemic areas. Rapid, accurate, accessible diagnostic tools are increasingly required as programmes extend parasite-based diagnosis and the prevalence of malaria decreases. RDTs to detect Plasmodium-specific antigens (proteins) in whole blood of infected people have emerged as an attractive alternative to microscopy. The currently available RDTs come in various formats (dipstick, cassette or hybrids) and contain antibodies bound to specific antigens, such as HRP2 specific to P. falci-parum, pan-specific and species-specific pLDH or aldolase specific to all the major Plasmodium species (P. falciparum, P. vivax, P. malariae, P. ovale) (Fig. 1).

To be widely useful, an RDT must be highly sensitive to ensure detection of all clinically significant malaria infections, highly specific to allow monitoring of low malaria prevalence and appropriate management of non-malarial fevers and highly stable to allow transport and storage in ambient conditions in malaria-endemic areas. Published field trials of RDTs show highly variable performance, probably due to poor manufacturing quality, incorrect storage and handling, poor

preparation and interpretation, and sometimes poor study methods, analysis and reporting (16–24). In general, diagnostic testing by microscopy or RDT to a level of 200 parasites/µL will reliably detect nearly all clinically relevant infections in malaria-endemic areas (10).

The number of RDTs available on the market has grown rapidly since their introduction in the late 1990s; on the basis of sales reported by 44 manufacturers, 314 million tests were sold in 2014 (1). Regulatory control of diagnostics is, however, often weak, and procurement agencies have had consider-able difficulty in selecting appropriate RDTs and ensuring their quality. In view of the inconsistency in the results of field studies and the inherent difficulties in assessing large numbers of products in a standardized way in field trials, WHO and partners embarked on a programme in 2002 to evaluate RDTs for malaria, in order to ensure standardized assessment of performance and to guide procurement decisions and regulatory mechanisms. Between 2003 and mid-2012, the programme was managed by WHO and TDR in partnership with FIND. After TDR withdrew its involvement in 2012, the WHO Global Malaria Programme assumed a coordinating role. A steering committee oversees the development of and modifications to standard operating procedures (25, 26). A network of specimen collection sites has been established to provide specimens for a global bank at the CDC and to facilitate local quality control (Fig. 2).

The reports of the previous five rounds of product testing have been released annually since 2009 (3–7). This sixth report adds data on the performance of 25 new products and updated data on 16 resubmitted RDTs. Testing for round 6 was conducted against an evaluation panel with characteristics similar to those of previous panels in terms of overall antigen concentration, parasite origin and parasite-negative blood samples (Annex S1). Most panel samples were retained from previous rounds, with 30 of 100 P. falciparum, 5 of 35 P. vivax and 15 of 100 negative samples replaced (new) in round 6.

4. objectIve

The objective of the programme is to evaluate malaria RDTs for performance in order to guide procurement of RDTs for use in the field in malaria-endemic countries.

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Figure 2: Network of specimen collection, characterization and testing sites

Countries or areas where malaria transmission occursCountries or areas with limited risk of malaria transmissionNo malaria

Malaria, countries or areas at risk of transmission, 2009

This map is intended as a visual aid only and not as a definitive source of information about malaria endemicity.Source: © WHO 2010. All rights reserved.

Collection and testing siteSpecimen characterization

Global specimen bank

QIMR

UCADKEMRIEHNRIEHNRI

CDC

HTD

CIDEIM

IMT IHRDCIPM

DRMIPCIPBIPB

RITM

UL

CDC, Centers for Disease Control and Prevention (Atlanta, United States of America); CIDEIM, Centro Internacional de Entrenamiento y Investigaciones Médicas (Cali, Colombia); DMR, Experimental Medicine Research Division (Department of Medical Research, Yangon, Myanmar); EHNRI, Ethiopian Health and Nutrition Research Institute (Addis Ababa, Ethiopia); HTD, Hospital for Tropical Diseases (London, United Kingdom); IHRDC, Ifakara Health Research and Development Center (Bagamoyo, United Republic of Tanzania); IMT, Instituto de Medicina Tropical (Universidad Peruana Cayetano Heredia, Lima, Peru); IPB, Institut Pasteur de Bangui (Bangui, Central African Republic); IPC, Institut Pasteur du Cambodge (Phnom Penh, Cambodia); IPM, Institut Pasteur de Madagascar (Antananarivo, Madagascar); KEMRI, Kenya Medical Research Institute (Kisumu, Kenya); QIMR, Queensland Institute of Medical Research (Brisbane, Australia); RITM, Research Institute of Tropical Medicine (Manila, Philippines); UCAD, Université Cheikh Anta DIOP (Dakar, Senegal); UL, University of Lagos (Lagos, Nigeria).

Figure 1: Mode of action of antigen-detecting malaria RDTs

a

b

c

Bound Ab

Free labelledAb

Captured Ag–labelledAb complex

Capturedlabelled Ab

Parasite Agcaptured bylabelled Ab

Labelled Ab–Agcomplex capturedby bound Ab oftest band

Lysing agentand labelled Ab

Test line(bound Ab)*

Parasitized blood

Bu�er/�ushing agent

Control line(bound Ab)*

Nitrocellulose strip

Blood and labelled Ab �ushed along strip

*Not normally visible

Labelled Abcaptured by bound Ab ofcontrol band

Mode of action of common malaria RDT format:

(a) Dye-labelled antibody (Ab), specific for the target antigen, is present on the lower end of the nitrocellulose strip or in a well provided with the strip. Antibody, also specific for the target antigen, is bound to the strip in a thin (test) line, and either antibody specific for the labeled antibody, or antigen (Ag), is bound at the control line.

(b) Blood and buffer, which have been placed on the strip or in the well, are mixed with the labelled antibody and are drawn up the strip across the lines of bound antibody.

(c) If antigen is present, some labelled antibody will be trapped on the test line. Other labelled antibody is trapped on the control line.


5. mAterIAls And metHods

5.1. test selection In January 2014, the WHO–FIND malaria RDT evaluation programme issued a call for expressions of interest to manufacturers of malaria RDTs with information on the requirements for submission of a product to round 6 and the conditions for participation in the evaluation programme (27). Manufacturers of products that had not been retested since round 2 were informed they must resubmit these products; otherwise, the performance characteristics would be removed from the summary results document, which is a compilation of the results of all previous rounds of testing. This rule was introduced in round 5 to ensure that all products were retested < 5 years after the primary submission. Other standard requirements included valid ISO 13485:2003 certification of all manufacturing sites, sufficient quantities of products (1100

tests from each of two lots1), compliance with the product definition2 and deadlines for document submission.

Twenty-seven manufacturers, proposing 53 products, responded to the call. Finally, 41 products from 22 manufac-turers were tested in round 6 (Table 1a). Catalogue numbers and verification with manufacturers showed that 16 of the 41 products (39%) had been submitted previously to one or more rounds, including two (5%) scheduled for compulsory resubmission (Table 1b). All the products met the minimum

1 Manufacturers were requested to supply an additional 500 RDTs per lot voluntarily to support the WHO-FIND evaluation of malaria recombinant antigens.

2 A working definition of a product can be found in Annex 2 (http://www.who.int/malaria/news/2015/EOI-letter-to-manufacturers-Rd7-annex-2jul2015.pdf?ua=1accessed 9 November 2015).

Table 1a: Manufacturers and products accepted into round 6 of WHO malaria RDT product testing programme

Manufacturer Product name Product codea Target antigen(s)

Access Bio, Inc. CareStart™ Malaria HRP2/pLDH (Pf)b G0181/G0181-ET F(pLDH)/ HRP2

Advy Chemical Private Limited

EzDx™ Malaria Pan/Pf Rapid test detection kitc RK MAL 001 pan(pLDH), HRP2

EzDx™ Malaria Pv/Pf Rapid Malaria antigen detection test RK MAL 003 V(pLDH), HRP2

EzDx™ Malaria Pf Rapid Malaria antigen detection test RK MAL 008 HRP2

Atomo Diagnostics PTY Limited ATOMORAPID™ MALARIA (PF/PAN) MMAL01 HRP2, pan(pLDH)

Bio Focus Co., Ltd.BioTracer™ Malaria P.f/PAN Rapid Cardc 17012 pan(pLDH), HRP2

BioTracer™ Malaria P.f/P.v Rapid Card 17412 V(pLDH), HRP2

BioNote, Inc.BIONOTE MALARIA P.f. Ag Rapid Test Kitc RG19-11 HRP2

BIONOTE MALARIA P.f & Pan Ag Rapid Test Kitc RG19-08 pan(pLDH), HRP2

Core Technology Co., Ltd. Coretests® One Step Malaria Pf/Pv Ag Test Device B42-21/B42-22 V(pLDH), HRP2

CTK Biotech, Inc.

OnSite Malaria Pf/Pv Ag Rapid Testc R0112C HRP2, V(pLDH)

OnSite Malaria Pf/Pan Ag Rapid Testc R0113C HRP2, pan(pLDH)

OnSite Malaria Pf Ag Rapid Testc R0114C HRP2

Guangzhou Wondfo Biotech Co., Ltd.

One Step Malaria P.f Whole blood Testc W37-C HRP2

One Step Malaria P.f/P.v Whole Blood Testc W056-C V(pLDH), HRP2

One Step Malaria P.f/Pan Whole Blood Test W62-C pan(pLDH), HRP2

Hangzhou Biotest Biotech Co., Ltd. RightSign® Malaria P.f. Rapid Test Cassette (Whole Blood) IMPF-C51 HRP2

Hema Diagnostic Systems Rapid 1-2-3® Hema® Cassette Malaria PF MAL-PF-CAS/25 (100) HRP2

Humasis Co., Ltd.

Humasis Malaria P.f/Pan Antigen Test ANMAL-7025 pan(pLDH), HRP2

Humasis Malaria P.f/P.v Antigen Test ANMIV-7025 V(pLDH), HRP2

Humasis Malaria P.f Antigen Test ANMPF-7025 HRP2

InTec Products, Inc. Advanced Quality™ One Step Malaria (Pf/Pv) Tri-line Test (whole blood)c ITP11003 TC40 V(pLDH), HRP2

Lumiquick Diagnostics, Inc.QuickProfile™ Malaria Pf/Pv Test 71050 V(pLDH), HRP2

QuickProfile™ Malaria Pf/Pan Test 71063 pan(pLDH), HRP2

Medsource Ozone Biomedicals Pvt. Ltd. Is It… Malaria Pf/Pv Device AL030 pan(pLDH), HRP2

http://www.who.int/malaria/news/2015/EOI-letter-to-manufacturers-Rd7-annex-2jul2015.pdf?ua=1



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Manufacturer Product name Product codea Target antigen(s)

Meril Diagnostics Private Ltd.Meriscreen Malaria Pf/Pan Ag MHLRPD-01 pan(pLDH), HRP2

Meriscreen Malaria Pf/Pv Ag MFLRPD-01 V(pLDH), HRP2

Nantong Egens Biotechnology Co., Ltd. Malaria PV/PF (pLDH/HRP2) Antigen Test Inf-72 V(pLDH), HRP2

Oscar Medicare Pvt. Ltd. Malaria Antigen Test-Pf MAG01040 HRP2

Premier Medical Corporation Ltd.

First Response® Malaria Antigen P. falciparum (HRP2) Card Test PI13FRC HRP2

First Response® Malaria Ag. pLDH/HRP2 Combo Card Test PI16FRC pan(pLDH), HRP2

First Response® Malaria Ag Pf/Pv Card Test PI19FRC V(pLDH), HRP2

RapiGEN Inc.

RapiGEN BIOCREDIT Malaria Ag Pf (HRPII) C10RHA25 HRP2

RapiGEN BIOCREDIT Malaria Ag Pf/Pv (HRPII/pLDH) C40RHA25 V(pLDH), HRP2

RapiGEN BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH)c C30RHA25 pan(pLDH), HRP2

Shanghai Kehua Bio-engineering Co., Ltd. KHB® Malaria Ag P.f/P.v Rapid Test KH-R-07-50 V(pLDH), HRP2

Standard Diagnostics, Inc.

SD Bioline Malaria Ag P.f/P.vb 05FK80 V(pLDH), HRP2

SD Bioline Malaria Ag P.f (HRP2/pLDH)c 05FK90 F(pLDH), HRP2

SD Bioline Malaria Ag P.f/P.f/P.v 05FK120 V(pLDH),F(pLDH), HRP2

Zephyr BiomedicalsFalciVax™ - Rapid Test for Malaria Pv/Pfc 503010025 V(pLDH), HRP2

Parascreen® - Rapid Test for Malaria Pan/Pfc 503030025 pan(pLDH), HRP2

pLDH, Plasmodium lactate dehydrogenase; HRP2, histidine-rich protein 2; V, P. vivax; F, P. falciparum a The product code corresponds to a specific configuration of the RDT, kit components and accessories. Therefore, changes to this configuration including the quantity

of tests, the contents or the manufacturing site are denoted by a different product code. Often this involves the end portion of the product code; however, the manufacturer should be contacted for full details.

b Indicates products submitted for compulsory retesting in round 6c These products have been submitted voluntarily in previous rounds of WHO malaria RDT product testing (round 1-5). For details on all product resubmissions refer to Table S1.

Table 1a: (continued)

Table 1b: Products due for compulsory resubmission in round 6

Manufacturer Product Product Code Participation in round 6a

Access Bio, Inc. CareStart™ Malaria HRP2/pLDH Pf test G0181 Yes

Amgenix International, Inc. OnSight™ - Malaria Pf Test 511-25-DB No

Amgenix International, Inc. OnSight™ - ParaQuick-2 (Pv,Pf) Malaria Test 537-25-DB No

Amgenix International, Inc. OnSight™ - PanScreen (Pan) Malaria Test 539-25-DB No

Bhat Bio-Tech India (P) Ltd Maleriscan® Malaria Pf/Pv MAT-50 No

HBI Co., Ltd. HiSens Malaria Ag P.f/P.v Card HR2823 No

HBI Co., Ltd. HiSens Malaria Ag Pf/Pv (HRP2/pLDH) Card HR2923 No

HBI Co., Ltd. HiSens Malaria Ag Pf HRP2 Card HR3023 No

Premier Medical Corporation Ltd. First Response® Malaria Ag pLDH I12FRC30 No

Span Diagnostics Ltd ParaHIT Pan M (dipstick) 55IC301-10 No

Span Diagnostics Ltd ParaHIT® total (dipstick) 55IC201-10 No

SSA Diagnostics & Biotech Systems diagnosticks- Malaria (Pf) Cassette KMFC6001 No

SSA Diagnostics & Biotech Systems diagnosticks- Malaria (Pf) Dipstick KMFD6007 No

SSA Diagnostics & Biotech Systems diagnosticks- Malaria (Pv/Pf) Cassette KMVFC6002 No

Standard Diagnostics, Inc. SD BIOLINE Malaria Ag Pv 05FK70 No

Standard Diagnostics, Inc. SD BIOLINE Malaria Ag Pf/Pv 05FK80 Yes

Unimed International Inc. FirstSign™ - PanCheck (Pan) Malaria Test 2104 CB-25 No

Unimed International Inc. FirstSign™ - ParaView-3 (Pan+Pv+Pf) Malaria Test 2103 CB-25 No

Zephyr Biomedicals Paramax-3 Rapid Test for Malaria Pan/Pv/Pf (device) 50320025 No

a The results of the first testing of the products in this list that were not retested in round 6 have been removed from Tables S2 and S3 and Figs S1 and S2 and are listed in Table S4.


Figure 3: Overview of malaria RDT product testing

RDT product testing flow chart

Panel detection scoreand false-positive rate

Heat stability Ease-of-use description

Test RDTs against high and low density samples

of phase 1 panel

Select RDTs from 2 differents lots Blood safety

Place in a 35°C

incubator

Store for 2 months at 75% humidity

Remove and allow RDTs to reach room temperature

Prepare RDTs with a 200 p/µL

sample

Prepare RDTs with a 2000 p/µL

sample

Place in a 45°C

incubator

Initial test (room temperature) 200, 2000 p/µL

Total time to obtain result

Number of timed steps

Quality of the instructions

Additional information• format• blood transfer method• items included in package• language• anomalies

Completedassessment

forms

Proceed to test RDTs against phase 2 panel,

if pass phase 1

In each case, read each result with:

Record results

Record results

Record results

Technician1

Technician2

performance requirements1 in the initial evaluation against the P. falciparum culture-derived panel and were therefore evaluated fully in phase 2.

Of the 41 products that were fully evaluated, 12 are designed to detect P. falciparum alone, 13 to detect and differentiate P. falciparum from non-P. falciparum malaria and 16 to differentiate P. falciparum from P. falciparum and P. vivax. Of these products, three detected P. falciparum pLDH. Two products had separate Pf-pLDH detecting lines and the third product combined P. falciparum pLDH with HRP2 on the same line. Annexes 1 and 2 give a comprehensive overview of the product characteristics.

5.2. the product testing protocol The testing process is outlined in Fig. 3 and in the Methods manual for product testing of malaria rapid diagnostic tests, version 6 (26). In brief, RDTs from each of two lots of each product were evaluated against a panel of parasite-positive and parasite-negative cryopreserved blood samples. Both lots were also tested for heat (thermal) stability, evaluated after 2 months’ storage at room temperature (21–24 °C), 35 °C and 45 °C. An ease-of-use description was completed on a standard assessment format, and common anomalies were recorded.

The testing and all the results were monitored by the WHO–FIND steering committee, and manufacturers were given 30 days to comment on the results for individual products before publication.

1 PDS > 80% against high-density (2000 parasites/µL) P. falciparum in culture

5.3. evaluation panelsRDTs were evaluated against three panels:

• P. falciparum culture lines (includes a subset, “manufac-turer’s panel”) at low (200 parasites/µL) and high parasite density (2000 parasites/µL);

• wild-type Plasmodium species (P. falciparum, P. vivax) from naturally infected humans diluted with parasite-negative samples to low (200 parasites/µL) and high parasite density (2000 or 50002 parasites/µL), all samples prepared from isolates that express HRP2; and

• a parasite-negative panel (“clean” samples and disease-specific or blood factor-specific samples).

An overview of sample collection and characterization is given in the methods manuals prepared for this purpose (25, 26). Characterization results for each round are available on the WHO GMP and FIND websites (28). Thus, each panel specimen was characterized for:

• species, by duplicate microscopy (two microscopists) and confirmation of mono-species infection by nested polymerase chain reaction (PCR);

• antigen concentration, by quantitative ELISA for HRP2, pLDH and aldolase; and

• the absence of malaria parasites by nested PCR and confirmatory testing for other diseases in the case of parasite-negative samples.

2 Three (3%) of the 100 P. falciparum dilution sample sets contained 200 and 5000 parasites/µL.

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Most P. falciparum samples in the global specimen bank were also characterized according to HRP2 sequence by PCR amplification and sequencing. This was not performed on samples collected after 2009, as accumulated evidence indicates that HRP2 variation has no significant effect on RDT sensitivity (29). The geographical origin of all samples was recorded.

panel compositionP. falciparum-cultured parasites panel

The programme selected culture-adapted strains of P. falci-parum from various geographical locations, including 13 strains with type B HRP2 sequence, five with type A and two with type C. All specimens were derived from the CDC culture bank and diluted in O-positive blood from donors in the USA (26).

Wild-type parasite panel

The parasite-positive wild-type (clinical) panel consisted of samples from 100 cases of P. falciparum and 35 cases of P. vivax malaria, from 11 collection sites in Africa, Asia and South America (Figs 2, 4a and 4b). Samples were collected from febrile patients and processed by standard methods designed to preserve the target antigen concentration (25). After dilution and cryopreservation, the samples were transferred to the global bank (WHO specimen bank) at CDC for further characterization. The concentrations of sample antigens (HRP2, pLDH, aldolase) determined by quantitative ELISA are shown in Table 3. The results are based on 98 P. falciparum samples for pLDH, 99 P. falciparum samples for HRP2 and 100 for aldolase, 34 P. vivax samples for pLDH and 35 P. vivax samples for aldolase. This panel is closely comparable to those of previous rounds (Annex S1).

Negative blood sample panel

The negative panel consisted of 52 “clean” parasite-negative samples from donor-derived blood obtained in banks or from volunteers in non-endemic (USA) and endemic areas (Kenya, the Philippines and Senegal) that had been found to be malaria-negative by microscopy and PCR. The negative sample panel also contained 48 parasite-negative samples from donors with diseases that might be used in the differ-ential diagnoses of malaria, that contained blood factors known to be common in the community or that could result in false-positive reactions in immunochromatographic tests (Table 2). All negative control samples were confirmed to be free of Plasmodium parasites by PCR amplification.

Figure 4a: Origin of phase 2 P. falciparum wild-type (clinical) samples (n=100)

Figure 4b: Origin of phase 2 P. vivax wild-type (clinical) samples (n=35)

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Table 2: Characteristics of Plasmodium spp. negative samples

Nature of negative samplea No.

Clean-negativeb 52

Anti-nuclear antibody positive (sera) 13

Anti-mouse antibody positive (plasma) 3

Rheumatoid factor positive (whole blood and sera) 6

Rapid plasma reagin positive (sera) 7

Chagas' disease antibody positive (plasma) 2

Dengue antibody positive (whole blood sera) 6

Leishmaniasis antibody positive (sera) 5

Schistosomiasis antibody positive (whole blood and sera) 6

a Whole blood unless indicated. Sera and plasma samples were reconstituted packed cells

b Healthy volunteers with no known current illness or blood abnormality


5.4. product registrationReceipt of each shipment of RDTs at the CDC was recorded in a dedicated RDT register. Temperature monitoring devices were offered to manufacturers free of charge to accompany RDT shipments to the CDC. All RDTs were stored at room temperature (21–24 °C) immediately, and temperature moni-tors were labelled with the date of receipt and forwarded for data extraction and analysis, when applicable.

5.5. specimen panel registrationAll panel specimens were assigned unique identification numbers at the collection sites and stored in aliquots of 50 µL at –70 °C until testing. All data pertaining to specimen identification, storage location and characterization are stored in a secure, dedicated database.

5.6. test phasesThe evaluation is divided into two phases. Each lot of RDTs was evaluated independently. Lots 1 and 2 of each product were tested alternately against defined sample sets1, testing of a set of lot 1 of all products was completed, then a set of lot 2 was tested, until both lots of all products had been tested against all panel samples.

Phase 1. A screening step is used to allow selection of RDTs that meet the minimal quality requirements. Products from two lots were evaluated against a panel of 20 culture-derived P. falciparum samples at high (2000 parasites/µL) and low (200 parasites/µL) parasite density, and against 20 clean negative samples. To progress to the full evaluation (phase 2), a product evaluated in phase 1 must achieve a minimum PDS of 80% against the samples containing 2000 parasites/µL.

Phase 2. Products from two lots are evaluated against a panel of diluted clinical blood samples containing wild-type parasites and a parasite-negative panel, evaluated for heat (thermal) stability and assessed for ease of use. Round 6 included the first heat stability assessment against a P. vivax isolate. Because the number of aliquots were smaller, fewer replicate RDTs were performed.

• Performance assessment: The mixed parasite-positive and parasite-negative panel comprised 100 P. falciparum, 35 P. vivax at two parasite densities (200 parasites/µL and

1 A sample set typically consists of 13 P. falciparum specimens and five P. vivax specimens at 200 parasites/µL and 2000 parasites/µL (or 5000 parasites/µL) and 13 malaria-negative samples.

2000 (or 5000) parasites/µL2) and 100 parasite-negative samples.

• Heat stability evaluation (P. falciparum-detecting prod-ucts): 15 RDTs from each of two lots were tested against a single culture-derived P. falciparum isolate (Nigeria XII strain, P. falciparum HRP2 sequence type B) with a typical antigen concentration3 of 200 parasites/µL, five RDTs from each lot against P. falciparum Nigeria XII strain at 2000 parasites/µL and four RDTs from each lot against a negative sample, which were all tested at baseline and after RDTs were maintained for 60 days at room temperature (< 25 °C), 35 °C and 45 °C, at 75% humidity.

Evaluation of heat stability for P. vivax-detecting products: Four RDTs from each of the two lots were tested against a single wild-type P. vivax sample4 (from Ethiopia) at 200 parasites/µL, two RDTs from each lot against P. vivax at 2000 parasites/µL and four RDTs from each lot against a negative sample, at baseline and after RDTs were main-tained for 60 days at room temperature (< 25 °C), 35 °C and 45 °C, at 75% humidity. The pLDH concentrations in the samples chosen were above average in order to increase the probability of good RDT baseline reactivity, thereby allowing an interpretable assessment of stability or degradation.

• Ease-of-use assessment: After technicians had become familiar with the test device, they jointly described its blood safety characteristics, the quality of the instructions, the number of timed steps and the total time to a result, using a standard reference guide (26).

• RDT anomalies: During testing, technicians regularly reported the RDT anomalies listed below (not all of which were observed in round 6) and in Fig. AS2.1. When anoma-lies were noted frequently, a photograph was taken of at least one example.• red background• red background obscuring test line(s)• incomplete clearing • incomplete migration• failed migration• ghost test line(s)• patchy, broken test line(s)

2 Three (3%) of the 100 P. falciparum dilution samples sets were at 200 and 5000 parasites/µL.

3 The P. falciparum sample had18.8ng/mL of HRP2, 21.1ng/mL of pLDH and 0.49ng/mL of aldolase.

4 The P. vivax sample had 143.9ng/mL of pLDH and 44.4ng/mL of aldolase.

Table 3: Malaria antigen concentrations (ng/mL) in round 6 wild-type, low parasite density (200 parasites/µL) samples

pLDH HRP2 Aldolase

P. falciparum P. vivax P. falciparum P. falciparum P. vivax

Mean 15.6 16.9 12.2 1.5 7.7

Median 11.8 15.2 8.1 1.2 6.5

Maximum 53.5 44.8 62.5 9.1 15.1

Minimum 0.2 1.6 0.7 0.0 1.7

Standard deviation 12.0 11.8 13.3 1.6 3.7

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• diffuse test line(s)• strip misplaced in cassette (shift)• specimen pad not seen in sample window• buffer remains pooled in buffer well

5.7. performing rapid testsAll RDTs were maintained at room temperature (21–24 °C) until first use. When applicable, the desiccant was inspected for colour change, and products were discarded if they were present. Technicians were rotated and blinded to the sample type and to each other’s results. RDTs were labelled with a sample identification number and the date on which test was performed. The tests were used according to the manufacturer’s instructions, except that the recommended volume of blood was transferred by micropipette from the sample tube; co-packaged blood transfer devices were not used. The result was recorded by a technician at the minimum

specified reading time, and a second technician re-read the result within 30 min for internal monitoring and to obtain information for the manufacturer. Annexes 1 and 2 give a descriptive, illustrated summary of the test characteristics and steps and a guide to interpretation of results.

5.8. Interpreting the resultsThe results of control and test lines were recorded as negative or positive by each technician. Each test line was read against a standard colour chart and the band intensity graded as 0 (no visible band), 1, 2, 3 or 4 (1 being the weakest colour intensity and 4 being the strongest). If the control line was recorded as “0” (no visible band) by either technician, the test was recorded as invalid.

Figures 5 and 6 illustrate the testing sequence at low and high parasite density.

Figure 5: Testing procedure and calculation of panel detection score and band intensity for product A against a sample density of 200 parasites/µLThe first reading was at the minimum time specified by the manufacturer; the second reading was up to 30 min latera. A sample is considered detected only if all first test readings, from both lots, are positive, i.e. readings a, b, c and d must be positive.

Product A

c dReading

1Reading

1Reading

2Reading

2

Lot 2

Test 3 Test 4

a bReading

1Reading

1Reading

2Reading

2

Lot 1

Test 1 Test 2


first readings

Based on the positive results of first test reading (2 tests per lot), the mean band intensity score =a+b+c+d/4 (excluding negative results).

a Second reading results are for internal use only

Figure 6: Testing procedure and calculation of panel detection score and band intensity for product A against a sample density of 2000 parasites/µL The first reading was at the minimum time specified by the manufacturer; the second reading was up to 30 min latera. A sample is considered detected only if all first test readings, from both lots, are positive, i.e. readings a and b must be positive.

Product A

aReading

1Reading

2

Test 1

Lot 1

bReading

1Reading

2

Test 2

Lot 2


first readings

Based on positive results of first test reading (2 tests per lot), in each lot, the mean band intensity score =a+b/2a Second reading results are for internal use only


5.9. recording anomaliesAnomalies are defined as unexpected features that appear when performing an RDT. Anomalies have been observed since round 1; following the appearance of each, technicians agreed upon terms with which to identify them. During earlier rounds of testing, their presence was informally recorded (and

reported to manufacturers), but, in round 6, the frequency of anomalies was recorded. Some anomalies do not interfere with the interpretation of results, while others may obscure test or control lines and therefore affect the interpretation and create confusion. Manufacturers are encouraged to reduce or eliminate anomalies or, at minimum, acknowledge them in their instructions for use.

6. dAtA mAnAgement

Receipt of products was hand-recorded in a RDT register at the CDC as per standard operating procedures. Data associated with specimen collection and characterization were recorded, first on hard-copy report forms as per the standard operating procedure at the collection sites (Fig. 2), the Hospital of Tropical Diseases (quantitative ELISA results) and the CDC (PCR results), and then entered directly into Excel, followed by importation into a specially developed database.

The results of product panel testing and heat stability testing conducted at the CDC were recorded on report forms by

each technician individually, as per the standard operating procedure. The results were entered in duplicate and analysed for discrepancies.

All source documents and electronic records of the study data are maintained in secure storage until the conclusion of the evaluation, data analysis and publication of the report.

Individual product testing reports and raw data were sent to manufacturers on 21 September 2015 for a 30-day review period before production of the final report.

7. QuAlIty AssurAnce

Product testing follows standard operating procedures developed during previous testing rounds, which are based on recommendations by expert consultants, with minor modifications by the steering committee before round 6 (26). Overall, the quality of critical steps was controlled as described below.

7.1. Quality of malaria rdts and their useAll RDTs were stored in a controlled environment at room temperature (21–24 °C). The pouch was opened, and, if

applicable, the desiccant was checked for colour change immediately before use. The manufacturer’s instructions were followed, except for use of the blood transfer device provided by the manufacturer: a micropipette was used to ensure the correct blood volume.

A temperature monitoring device was offered to manufac-turers to be shipped with the RDTs to the testing site (CDC). Lots were analysed at temperatures above and below the manufacturer’s recommended storage conditions.

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7.2. Quality and objectivity of rdt readingsThe results were read under good lighting by trained techni-cians tested for visual acuity and were doubly entered into the database. Technicians were rotated, and the readings of a second technician were used for internal monitoring. The summarized results were reviewed in detail, and potential discrepancies were identified and cross-checked against source laboratory report forms.

All wild-type parasite samples used in phase 2 were rand-omized with parasite-negative samples and re-labelled, then exchanged with the second technician, for blinded reading of the RDT results.

7.3. Quality of wHo specimen bank samplesStandard operating procedures were established for the preparation of all specimen bank samples (25). Culture lines of parasites and wild-type samples were selected on the basis of previous evidence and data from specific studies. All diluted parasite samples were stored and transported at –70 °C and were used only once within 8 hours of thawing.

7.4. Quality of the product testing site The Division of Parasitic Diseases and Malaria, Center for Global Health, CDC, is the main operating component of the Department of Health and Human Services of the USA for malaria control and prevention. Laboratories within the Division are accredited by Clinical Laboratory Improvement Amendments and are monitored by an internal quality management system.

8. etHIcAl consIderAtIons

Each specimen collection site obtained approval from a WHO research ethics review committee and/or a local institutional review board for specimen collection, transport and archiving

of blood samples for the purpose of product testing, lot testing and quality assurance.

9. dAtA AnAlysIs

9.1. measures of parasite detection: panel detection score and positivity ratesAs shown in Figure 5, a product must return four positive test results at the manufacturers’ recommended minimum reading time (two from lot 1, two from lot 2 at the initial reading time) when tested against a parasite density of 200 parasites/µL to contribute to its PDS. When tested against 2000 or 5000 parasites/µL (Fig. 6), the product must return two positive tests at the manufacturers’ recom-mended minimum reading time (one from each lot). Thus,

the PDS is a measure of inter-test and inter-lot consistency, as well as the ability of the test to detect antigen. The PDS for P. falciparum indicates an RDT result that confirms the presence of P. falciparum when tested against cultured and wild-type P. falciparum samples, while the P. vivax PDS indicates Plasmodium-positive/P. falciparum-negative results when tested with wild-type P. vivax samples.

The positivity rate is the percentage of all tests of a particular product that returned a positive result at the manufacturers’ recommended minimum reading time when tested against a P. falciparum or P. vivax sample.


9.2. false-positive resultsFalse-positive results are analysed and reported as two groups: those with incorrect species identification and those that returned a positive result for samples that do not contain Plasmodium spp. Specifically, the false-positive rate is the percentage of all tests of a particular product that returned a positive test result when it should not have when obtained at the manufacturer’s recommended minimum reading time.

9.2.1 Incorrect species identificationA test is considered to have returned an incorrect species result if a positive P. falciparum test line appears when testing a sample containing non-P. falciparum (P. vivax) parasites. Fig. 7 illustrates the various possibilities for incor-rect species identification in combination tests. For example, if P. falciparum samples result in only a visible pan-specific (or non-P. falciparum-specific) test line in combination tests, the result is considered to be a false-positive for non-P. falciparum parasites.

9.2.2 false-positive results for Plasmodium-negative samplesAny positive reading of samples with no Plasmodium parasites is considered a false positive. In phase 2, parasite-negative samples are clean negative samples and samples containing other infectious agents (dengue, leishmania, Chagas, schisto-soma and rapid plasma reagin, which is indicative of syphilis

infection) and immunological factors (rheumatoid factor, anti-nuclear antibodies, anti-mouse antibodies) (Table 2).

9.3. band intensityAll positive test results were recorded with their band inten-sity against a standard reference chart, matched closely to line colour. On the basis of the results of the first reader, the distribution of band intensity results is presented as the mean band intensity of positive results. In addition, the intensity was expressed for each possible result (0, 1, 2, 3 or 4) as the percentage recorded at that level1.

9.4. lot agreement Agreement between test lots is calculated from the number of samples that return a positive result on both RDTs tested in that lot against parasite-positive samples at 200 parasites/µL, and on the single RDT from each lot tested against samples at 2000 (or 5000) parasites/µL. High inter-lot agreement indicates consistency in detecting malaria parasites. When one test is invalid and the other positive, positive agreement is recorded. Fig. 8 shows sample calculations for lot agreement.

1 A standard intensity comparison chart is used, which allows matching to the closest of four common colour variants of labelled antibodies used in RDTs, each at four levels of intensity.

Figure 7: Classification of incorrect species identification with combination malaria RDTs

Pf/pan combination tests

Panel sample Pf + / Pan - Pf + / Pan + Pf - / Pan + Pf - / Pan -

Pf False-positive (non-Pf) Negative

Pv False-positive (Pf)

False-positive (Pf) Negative

Pf/Pv combination tests

Panel Pf + / Pv - Pf + / Pv + Pf - / Pv + Pf - / Pv -

Pf False-positive (Pv)

False-positive (non-Pf) Negative

Pv False-positive (Pf)

False-positive (Pf) Negative

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sult

s


9.5. Invalid testsInvalid tests are those deemed invalid during testing of both lots, with samples at 200 parasites/µL and 2000 (or 5000) parasites/µL.

9.6. Heat (thermal) stability The results of heat stability testing are reported as the number of positive tests against one cultured P. falciparum or one wild-type P. vivax parasite sample at 200 and 2000 parasites/µL based on the first reading of two lots at each parasite density (maximum score is 30 (P. falciparum) or eight (P. vivax) against 200 parasites/µL samples and 10 (P. falciparum) or four (P. vivax) against 2000 parasites/µL samples)1 and mean band intensity (for positive tests only based on the first reading) after the lots were stored at room temperature (21–25 °C) and at 35 °C and 45 °C for 2 months.

1 Fifteen tests per lot against 200 parasites/µL samples and five tests per lot against 2000 parasites/µL for P. falciparum samples and four tests per lot against 200 parasites/µL samples and two tests per lot against 2000 parasites/µL for P. vivax samples. Invalid results were excluded from analysis.

9.7. Anomalies The presence and frequency of commonly observed anoma-lies – red background, red background obscuring test line(s), incomplete clearing, incomplete migration, failed migration, strip misplaced in cassette (shift), specimen pad not seen in the sample window, ghost test line(s), diffuse test line(s), patchy broken line(s) and buffer remains pooled in buffer well – were routinely recorded for all round-6 products. Photographs and descriptions are shown in Fig. AS2.1.

Figure 8: Explanation of lot agreement calculation Test results

(1= positive, 0 = negative)Derived values

(1= both positive, 0 = both negative)

Lot 1 Lot 2 (a) (b) (d) (f)

Test 1reader 1

Test 2reader 1

Test 1reader 1

Test 2reader 1 Lot 1 tests Lot 2 tests Comparison

of lot resultsContribution to

overall

Sample 1 1 1 1 1 1 1 1 1Sample 2 1 0 0 0 Disagree 0 Can’t compare 0Sample 3 0 1 0 1 Disagree Disagree Can’t compare 0Sample 4 0 0 0 0 0 0 0 0Sample 5 1 1 1 1 1 1 1 1

PDS = sum (f) / number of samples = 2/5 = 40Lot 1 PDS = sum (a) / number of samples = 2 / 5 = 40Lot 2 PDS = sum (b) / number of samples = 2 / 5 = 40 Positivity = number of positive results / total number of tests = 11 / 20 = 55%

Agreement between tests = (count number of 0 and 1s in (a) and (b)) / (number of samples x 2 lots) = 7 / 10 = 70% Agreement between lots = (count number of 0 and 1s in (d)) / (number of samples - ‐ number of “can’t compare” in (d)) = 3 /3 = 100%

Note: reader 1 = Technician 1 in raw data files


10. relAtIon between pArAsIte densIty And AntIgen concentrAtIon

Malaria RDTs detect parasite-derived antigen. The relation of the concentration of antigen available from the blood sample (after lysis of red cells and parasites) to the peripheral parasite density varies widely because of a series of host and parasite factors (Box 4).

In establishing panels for the product testing programme that reflect possible variations in antigen concentration for parasitaemia of 200 parasites/µL, a large number (> 300) of wild-type parasite samples from clinical cases in different geographical areas were analysed by quantitative ELISA for

HRP2, pLDH and aldolase. Only samples with antigen values within the 90th percentile for HRP2, pLDH and aldolase were selected for the performance panels. Furthermore, the distribution of antigen levels for HRP2, pLDH and aldolase was compared with that in previous rounds to ensure consistency. No statistically significant differences in average antigen levels between the panels for rounds 1–6 were detected for any of the antigens (p > 0.5, Kruskal-Wallis test). Therefore, the panels used for the product testing rounds can be considered comparable (Annex S1).

11. lAborAtory versus fIeld-bAsed mAlArIA evAluAtIons of rApId dIAgnostIc tests

Despite the strengths of the product testing programme, the evaluations are not completely analogous to field testing of malaria RDTs. In order to compose a panel that could be used to evaluate RDTs reproducibly, blood samples must be diluted, frozen and stored below −70 °C; however, blood that has undergone freezing and thawing is lysed and may not have exactly the same characteristics as fresh blood. Another difference from field evaluation is use of a micro-pipette to place blood in the RDT device rather than the blood transfer device provided by the manufacturer. This is necessary because blood is collected from a cryo-tube rather than a finger-prick and because the blood transfer devices provided with the different products vary (30). This technique also ensures the consistency of testing by reducing the likelihood of operator error. As all samples in the panel used for the evaluation are prepared from parasites that express HRP2, the results will not be predictive of field trial results of parasite populations with significant levels of HRP2 deletion (11–12). In addition, the population frequency of blood immunological

factors or infectious diseases, which can result in false-positive results, may vary. Therefore, the sensitivity and speci-ficity of an RDT in the field depends on the epidemiological situation. The evaluation reported here does not predict sensitivity or specificity in a given field situation but the rates of detection of target antigens and false-positive results of RDTs against a standardized panel in a controlled, repeatable manner. As the panel is meant to be a close approximation to field samples, the detection rates of different products will be reflected in similar differences in the field. The panel is designed to include a large number of samples that are close to the limit of detection of RDTs (200 parasites/µL) and is therefore likely to discriminate between them more clearly than a field trial. It follows that, in settings where the parasite density is very high, no differences in the PDS or positivity rates of tests or much smaller differences will be observed than those reported against the WHO evaluation panel. Furthermore, where the parasite density is very low, the detection rates may be lower than those reported here.

Box 4. Explanations for variable antigen concentrations in samples with the same parasite density

• variationinantigenexpressionamongisolates

• differentdurationsofinfections(accumulatingantigens)

• differentparasitegrowthstagesatthetimeofcollection(expressingdifferentlevelsofantigens)

• presenceofcirculatingHRP2frompreviouscyclesofgrowth

• HRP2producedbyparasitessequesteredinthehost’svasculartissuesthatcannotbeaccountedforintheestimateofparasitedensity on the blood slide (29)

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Field trials have a place in product selection, particularly in determining which of a short-list of products is most appropriate for the technicians and situation of its intended use in a programme (e.g. ease-of-use characteristics). Such trials should have carefully defined objectives and procedures designed to achieve them. Trials to determine the probable field sensitivity and specificity of a product also have a place but require large samples and populations with low

parasite densities if significant differences are to be found between well-performing products; they must also be closely controlled and are therefore expensive. Such trials do not allow comparison of a large number of products. WHO has published recommendations for good practice in malaria field trials (31), which should be followed to improve the reproducibility and quality of the results.

12. results

12.1. summaryRound 6 of WHO malaria RDT product testing provided results for 41 products evaluated against P. falciparum culture samples, and all the products proceeded to evaluation against wild-type samples collected from parasitaemic patients on three continents and a large panel of parasite-negative samples. Heat stability was assessed at the temperatures commonly encountered in malaria-endemic countries. Thirteen research institutes were engaged in either sample collection or sample characterization to establish the evaluation panels. Between August 2014 and June 2015, approximately 64 370 RDTs were tested at the CDC.

The main results are presented in Tables 4 and 5, which group the RDTs by the species they are designed to detect, i.e. P. falciparum only, P. falciparum and all species or P. falciparum and P. vivax. Note that only tests against P. falciparum and P. vivax were evaluated, and the evaluation therefore does not indicate whether a product intended to detect other species can do so.

PDS values at both high and low parasite concentrations are presented, as are false-positive rates and the percentages of invalid test results. Tests in each category are listed alphabetically, but the results are colour-coded according to WHO-recommended RDT procurement selection criteria (Box 3). When choosing an appropriate product, it is important also to review its thermal stability (Tables 6a and 6b) in the context of the expected conditions of transport and storage in the field.

The results of the evaluation are listed below.

• The overall range of results against wild-type P. falciparum and negative samples, including P. falciparum PDS, P. falciparum positivity rate and heat stability, were similar to those in rounds 1–5 (3–7), but the false-positivity rates and P. vivax PDS and P. vivax positivity rates were better than in previous rounds.

The median PDS for P. falciparum was the same as in round 5 (85%), both being slightly lower than in round 4 (89.3%) at low parasite densities. No products in round

6 scored a PDS of 100% for the P. falciparum detecting line. The PDS for P. vivax at low densities has improved consistently since round 1 (median, 30%), the results for rounds 2, 3, 4, 5 and 6 being 75.0%, 51.4%, 61.8%, 65.7% and 82.9%, respectively. Two products achieved 100% PDS on their pan-pLDH and P. vivax pLDH lines when tested against P. vivax but had lower scores for their P. falciparum detecting lines. The median false-positive rate on clean negative samples and samples containing other infectious agents was 0%, while samples containing immunological factors had an overall false-positive rate of 0.9%.

• A number of RDTs consistently detected malaria at a low parasite density (200 parasites/µL), had low false-positive rates, were stable at tropical temperatures, are relatively easy to use and can detect P. falciparum, P. vivax or both, increasing the number of available well-performing tests from that in rounds 1–5.

• The performance of products varied at low parasite density (200 parasites/µL), but most showed high detection rates for P. falciparum and P. vivax at 2000 (or 5000) parasites/µL.

• All round-6 products had an HRP2 detecting line, and most products achieved a high PDS for P. falciparum detection.

• Several combination tests achieved PDS at the upper end of the range for both P. falciparum and P. vivax. (Fig. S3).

• There was little variation in the test performance of lots of round-6 products.

• Approximately half of the combination tests in which HRP2 was used for detection of P. falciparum returned positive results only on the HRP2 band at lower densities of P. falciparum. Manufacturers’ instructions should therefore classify P. falciparum infections as either HRP2 test line-positive alone or in combination with the pan-pLDH line.

Tables 4 and 5 summarize the performance of malaria RDTs against cultured P. falciparum parasites, blood containing wild-type P. falciparum and P. vivax parasites and Plasmodium spp.-negative samples. Detailed phase-1 and phase-2 results


Tabl

e 4:

Sum

mar

y ph

ase-

1 pe

rfor

man

ce o

f 41

mal

aria

RDT

s ag

ains

t 20

cul

ture

d P.

falc

ipar

um li

nes

at lo

w (2

00)

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Tabl

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Sum

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s ag

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Tabl

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Sum

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aria

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DS fo

r HRP

2 ba

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DH b

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Tabl

e 5:

Sum

mar

y ph

ase-

2 pe

rfor

man

ce o

f 41

mal

aria

RDT

s ag

ains

t w

ild-t

ype

(clin

ical

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falc

ipar

um a

nd P

. viv

ax s

ampl

es a

t lo

w (2

00)

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high

(200

0a)

para

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den

sity

(pa

rasi

tes/

μL)

an

d Pl

asm

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m s

pp. n

egat

ive

sam

ples

(con

tinue

d)


of product testing are given in Annexes 3 and 4, respectively. The data are shown graphically in Figs. 9–19.

12.2. phase 1: P. falciparum culture panelAll tests consistently detected 100% of cultured P. falciparum parasites at high parasite density (2000 or 5000 parasites/µL); however, the PDS was variable (65–100%) at low parasite density (200 parasites/µL) (Fig. 9).

Figure 9: Phase-1 P. falciparum panel detection score of malaria RDTsa at low (200) and high (2000) parasite density (parasites/μL)

100

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Pan

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2000 (pLDH)

a All RDTs target HRP2 and two products (05FK90 and 05FK120) target both HRP2 and Pf-pLDH. Pf-pLDH based results are presented separately in Table 4. b A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.

Re

sult

s


12.3. phase 2: wild-type P. falciparum and P. vivax and Plasmodium spp.-negative samples 12.3.1 P. falciparum detectionAll 41 products in round 6 were designed to detect P. falci-parum. As in phase 1, all the tests had a PDS ≥ 95% for P. falciparum samples at high parasite densitiy. Eleven of the 12 products specific for P. falciparum alone achieved a PDS ≥ 75% against samples with low parasite density (Table 5, Fig. 10).

Figure 10: Phase-2 P. falciparum panel detection score of malaria RDTs at low (200) and high (2000a) parasite density (parasites/μL)b,c

200

200 (HRP2)

200 (pLDH)

2000

2000 (HRP2)

2000 (pLDH)

Pan

el d

etec

tion

scor

ed

100

75

50

25

0

Adv

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d Q

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Test

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51

a 3 (3%) of the 100 P. falciparum dilution samples sets were 200 and 5000 parasites/µLb Phase 2 evaluation panel consisted of 100 clinical blood samples containing wild type P. falciparum. RDTs performed = 2 tests x 2 lots at 200 p/μL and 1 test x 2 lots

at 2000 p/μLc All RDTs target HRP2 and two products (05FK90 and 05FK120) target both HRP2 and Pf-pLDH. Pf-pLDH based results are presented separately in Table 5 d A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.


12.3.2 P. vivax detection Fig. 11 shows that 28 of 29 (97%) products designed to detect P. vivax consistently detected ≥ 75% at high parasite density (2000 parasites/µL), and 17 (59%) achieved the same threshold of PDS against samples with 200 parasites/µL. The overall detection rate in low-parasite density wild-type P. vivax samples was lower than that for P. falciparum. At a low parasite density (200 parasites/µL), 12 products had a PDS ≥ 90%, and 12 had a PDS < 75% (Table 5, Fig.11), which is an improvement on round-5 results in which only eight products had a PDS ≥ 90% and 19 had a PDS < 75%.

12.3.3 combined detection of P. falciparum and P. vivax Of the 29 pan-specific and combination tests, 16 (55%) had a PDS ≥ 75% for both P. falciparum and P. vivax at a low parasite density (200 parasites/µL) (Table 5). Most products performed well at a high parasite density.

Figure 11: Phase-2 P. vivax panel detection score of malaria RDTs at low (200) and high (2000) parasite density (parasites/μL)a,b

Pan

el d

etec

tion

sco

rec

100

75

50

25

0

2000

200

Adv

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Test

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a Phase-2 evaluation panel consisted of 35 clinical blood samples containing wild type P. vivax; RDTs performed = 2 tests x 2 lots at 200 p/μL and 1 test x 2 lots at 2000 p/μL.

b All RDTs target pan-pLDH or Pv-pLDH c A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.

Re

sult

s


12.3.4 P. falciparum and P. vivax positivity rate The positivity rate was calculated in addition to the PDS, to measure the number of times a test returned a positive result. As expected, the positivity rates were higher than the PDS but mirrored the PDS against wild-type P. falciparum and P. vivax samples (Figs 12 and 13).

12.3.5 band intensity Although RDTs do not provide quantitative results, the techni-cians graded positive results according to a standard colour chart and calculated the mean band intensity for positive results (Annex 4, Tables A3.2 (for phase 1), A4.2 and A4.3 (for phase 2)). A positive correlation was found between the PDS and band intensity (Spearman rank correlation, r = 0.80, p < 0.001 for the P. falciparum phase-2 panel and r = 0.90, p < 0.001 for the P. vivax panel).

Figure 12: Phase-2 P. falciparum panel detection score and positivity rate at 200 parasites/µLa

100

75

50

25

0

Pan

el d

etec

tion

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reb/P

osi

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)

Positivity rate

Panel detection score

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a Phase-2 evaluation panel consisted of 100 clinical blood samples containing wild-type P. falciparum. RDTs performed = 2 tests x 2 lots at 200 p/μL and 1 test x 2 lots at 2000 p/μL.

b A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive.c The total number of times a test returned a positive result divided by the total number of times it should have (x100).


Of the combination RDT products containing a pan test band that gave a positive indication for P. falciparum against low-density P. falciparum samples, 47.1% (1105/2346) gave positive results on both the P. falciparum and pan test bands, and 51.8% (1216/2346) were positive only on the P. falciparum test band. A small proportion (1.1%, 25/2346) were positive only on the pan test band.

When the pan test band in the combination products was positive, the mean intensity of the band was 1.12 (standard

deviation, 0.09), which was significantly lower than the corresponding mean P. falciparum test band intensity (mean, 2.33; standard deviation, 0.27), when tested against the lower-density P. falciparum parasite panel (paired t test, p < 0.001). Products with higher mean pan test band inten-sities tended to also have higher P. falciparum test band intensities, but this correlation did not reach statistical significance (Spearman r = 0.385, p = 0.19, n = 13).

Figure 13: Phase-2 P. vivax panel detection score and positivity rate at 200 parasites/µLa

Positivity rate

Panel detection score

Adva

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Pan

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a Phase 2 evaluation panel consisted of 35 clinical blood samples containing wild type P. vivax. RDTs performed = 2 tests x 2 lots at 200 p/μL and 1 test x 2 lots at 2000 p/μL.

b A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.c The total number of times a test returned a positive result divided by the total number of times it should have (x100).

Re

sult

s


12.3.6 false-positive rates No products had false-positive rates > 10% on 52 clean-negative samples for any test line (Figs 14 and 15). Eight products showed false-positivity rates between 5.2% and 8.6% (for one or both lots), against samples containing

immunological factors, which is much lower than the rates in previous rounds. Only one product had a high false-positive rate (25.9%) against the immunological abnormality samples, which appeared to be lot-specific. False positivity in this category was predominantly against samples containing human anti-mouse antibodies.

Figure 14: Phase-2 P. falciparum (P. falciparum test line) false-positive rate against clean-negative samplesa

Fal

se-p

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tive

rate

(%)

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20

15

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a Phase-2 evaluation panel included 100 Plasmodium spp.-negative samples, of which 52 were clean negatives from healthy volunteers with no known current illness or blood abnormality.


False-positivity rates against samples containing non-Plasmodium spp. infectious agents was much lower than in previous rounds. No products had high false-positivity rates, and five products showed false-positivity rates of 5.3–7.9% (for one or both lots). False positivity in this category was predominantly against schistosoma and dengue samples.

It is important to note only 19 samples contained non-Plasmodium infectious agents and 29 samples contained immunological factors. For detailed information on the blood abnormalities and pathogens that generated false-positive results in specific products, see Annex 4 (Tables A4.6–A4.9).

Figure 15: Phase-2 Plasmodium spp. (pan or P. vivax test line) false-positive rate against clean-negative samplesa

Fal

se-p

osi

tive

rate

(%)

25

20

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a Phase-2 evaluation panel included 100 Plasmodium spp.-negative samples of which 52 were clean negatives, from healthy volunteers with no known current illness or blood abnormality.

Re

sult

s


Products were assessed for false-positivity rates against species that they were not designed to detect (Tables A4.4 and A4.5). Overall, the rates were low, only one product showing > 10% false positivity for a P. vivax detecting line when tested against samples of P. falciparum at 2000 parasites/µL.

Importantly, there was no clear trend of higher false-positive rates in tests with higher PDS, indicating no clear relation between the sensitivity and specificity of the tests at these detection thresholds (Figs 16 and 17).

Figure 16: Phase-2 P. falciparum false-positive rate versusa P. falciparum panel detection scoreb at low parasite density (200 parasites/µL)

Fals

e-po

sitiv

e ra

te (%

)

25

20

15

10

5

0

0 25 50 75 100

P. falciparum PDS at 200 parasites/μLa False-positive rate is for clean-negative, only. b A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.

Figure 17: Phase-2 P. vivax false-positive ratea versus P. vivax panel detection scoreb at low parasite density (200 parasites/µL)

Fal

se-p

osi

tive

rate

(%)

P. vivax PDS at 200 parasites/μL

25

20

15

10

5

0

0 25 50 75 100

a False-positive rate is for clean negatives only.b A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.


12.4. performance of resubmitted products Of the products in round 6, 39% had been evaluated previ-ously. For nine of the resubmissions, this was the second testing, and seven had been tested more than twice. Figs 18 and 19 show the performance in the current and previous testing of products against wild-type P. falciparum and P. vivax at 200 parasites/µL and clean-negative samples that had been resubmitted compulsorily and voluntarily.

For the two products that had not been tested since round 2 (compulsory resubmissions), the change in PDS between the two rounds was –7.0% and –4.0%. The P. vivax-detecting product showed a change in PDS of –0.7%.

For the 14 products that were voluntarily resubmitted for testing, there was no significant correlation between the PDS for P. falciparum at lower parasite density in consecutive submissions (Spearman rank correlation, r = 0.067, p = 0.82). The median change in detection of P. falciparum was –6.8% (range, –18.0 to 12.0%), which was significantly different

Figure 18: Phase-2 P. falciparum panel detection scorea at low parasite density (200 parasites/µL) during initial and subsequenttestingofcompulsorilyandvoluntarilyresubmittedmalariaRDTs

Pan

el d

etec

tion

sco

rea

Fal

se-p

osi

tive

Pla

smo

diu

m s

pp

. rat

e o

n cl

ean-

neg

ativ

e sa

mp

lesb

(%)

Compulsory retest Voluntary retest

Panel detection score (prior submission)Panel detection score (round 6)False-positive (prior submission)False-positive (round 6)

a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive.b Clean-negative blood samples from healthy volunteers with no known current illness or blood abnormality.

Re

sult

s


from zero (Wilcoxon signed rank test, p = 0.041). Most of these products (10/16) detected P. vivax, and detection of this parasite improved slightly overall (median change, 10.2%; range, –28.6 to 60.0%); this change was not statisti-cally significant (Wilcoxon signed rank test, p = 0.44). No correlation was found in the PDS against P. vivax at a lower parasite density of consecutive submissions (Spearman rank correlation, r = 0.125, p = 0.73).

On re-testing, all false-positivity rates were < 2.5%, and the majority of resubmitted products (15/16) showed an improvement in their false-positivity rate against the clean negative samples. The one product that did not improve increased by only 0.1%.

Figure 19: Phase-2 P. vivax panel detection scoreaatlowparasitedensity(200parasites/µL)duringinitialandsubsequenttesting of compulsorily and voluntarily resubmitted malaria RDTs

Panel detection score (prior submission)Panel detection score (round 6)False-positive (prior submission)False-positive (round 6)

Pan

el d

etec

tion

sco

rea

Compulsoryretest Voluntary retest

Fal

se-p

osi

tive

Pla

smo

diu

m s

pp

. rat

e o

n cl

ean-

neg

ativ

e sa

mp

lesb

(%)

100

90

80

70

60

50

40

30

20

10

0

100

80

60

40

20

0

a Panel detection score - A sample is considered detected only if all RDTs from both lots read by the first technician, at the minimum specified reading time, are positive. b Clean-negative blood samples from healthy volunteers with no known current illness or blood abnormality.


13. HeAt stAbIlIty

13.1. summaryA single P. falciparum culture sample and single wild-type P. vivax sample were used as the reference samples to test heat stability. A wild-type P. vivax sample was used as continuous in vitro culturing of P. vivax is very difficult, largely because of the selective invasion of reticulocytes by the para-site. This is the first round in which the stability of test lines to detect non-P. falciparum parasites has been tested. Because of the large number of aliquots used to assess heat stability, fewer replicate RDTs were tested against P. vivax, with four assessed against the 200 parasites/µL sample and two against the 2000 parasites/µL sample, for each of the two lots. The results of heat stability testing are summarized in Tables 6a and 6b, and detailed results are presented in Annex 4 (Tables A4.10–A4.18) and in Figs. 20–29, which show the results for the two lots combined. The maximum scores were 30 (15 tests per lot) against P. falciparum for 200 parasites/µL and 10 for 2000 parasites/µL (five tests per lot). The maximum score against P. vivax was 8 for 200 parasites/µL (four tests per lot) and 4 for 2000 parasites/µL (two tests per lot).

Confirmatory data on the stability of recent production lots of all tests can be obtained from the manufacturers and through the WHO–FIND lot-testing programme during product selection for procurement of RDTs.

13.2. Plasmodium falciparum Ten of 12 P. falciparum-only RDTs with an HRP2 test line were heat-stable. Thus, they detected a cultured P. falci-parum sample the same number of times when stored at room temperature (< 25 °C) or at 35 °C or 45 °C with (75% humidity) for 2 months (Fig. 20) as at baseline. Two products showed a slight loss in detection at 35 °C but not when stored at 45 °C. One P. falciparum-only detecting product had a line that detected P. falciparum pLDH (in addition to an HRP2 line). This product showed clear deterioration in detection after incubation only on the P. falciparum pLDH line.

The HRP2-detecting line of 20/29 combination tests was heat stable against a cultured P. falciparum sample. The other nine products showed only a slight loss in detection at one of the incubation times. One product detected both HRP2 and P. falciparum pLDH (on separate lines) and showed

poor detection on the P. falciparum pLDH at baseline, and detection diminished after incubation.

Many combination test products had pan lines that poorly detected low-density P. falciparum samples at baseline. Furthermore, tests with a baseline positivity < 100% showed unpredictable variation in positivity rates on subsequent testing, indicating that they were on the borderline of visi-bility. Two of the three combination tests with good baseline pan line reactivity to the low-density sample showed good detection throughout, while one showed a marked reduction in performance after 2 months at 45 °C. Some combination P. falciparum test lines were stable at 35 °C but lost the ability to detect antigen after incubation at 45 °C. As reported previously, a few products showed better performance after incubation. The stability of pan-pLDH-detecting test lines was much poorer than that of HRP2-detecting test lines (See Figs 20–25).

13.3. Plasmodium vivaxThis was the first round to test the heat stability of P. vivax detecting lines. Many (8/13) combination RDTs with a pan-LDH test line were heat-stable when tested against a wild-type P. vivax sample. Tests with baseline positivity < 100% showed unpredictable variation in positivity rates on subsequent testing, indicating that they were on the borderline of detection. Some products showed improved detection after incubation, while others showed diminished detection.

The P. vivax pLDH line was less stable when tested against the P. vivax sample, but there was still a selection (5/16) of heat-stable combination products. Some of the remaining products had better detection after incubation, while others showed diminished detection, unpredictable variation or poor detection throughout (see Figs 26–29).

Overall, both P. falciparum and P. vivax detecting prod-ucts were more stable against samples with high (2000 parasites/µL) rather than low (200 parasites/µL) parasite density, as minor deterioration will not be apparent at high parasite density.

Re

sult

s


Tabl

e 6a

: Hea

t st

abili

ty t

estin

g re

sult

s fo

r 41

mal

aria

RDT

s on

a c

ultu

red

P. f

alci

paru

m s

ampl

e at

low

(200

) an

d hi

gh (2

000)

par

asit

e de

nsit

y (p

aras

ites

/μL)

. Po

siti

vity

rat

e at

bas

elin

e (r

oom

tem

pera

ture

) an

d af

ter

60 d

ays’

incu

batio

n at

roo

m t

empe

ratu

re, 3

5 °C

and

45

°Ca

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Posit

ive

test

res

ults

for

P.

fal

cipa

rum

(Pf

line)

Posit

ive

test

res

ults

for

P.

fal

cipa

rum

(pan

line

)Po

sitiv

e te

st r

esul

ts f

or

P. f

alci

paru

m (P

f lin

e)Po

sitiv

e te

st r

esul

ts f

or

P. f

alci

paru

m (p

an li

ne)

200

para

sites

/µL

200

para

sites

/µL

2000

par

asite

s/µL

2000

par

asite

s/µL

Base

line

Room

te

mp

35 °C

45 °C

Base

line

Room

te

mp

35 °C

45 °C

Base

line

Room

te

mp

35 °C

45 °C

Base

line

Room

te

mp

35 °C

45 °C

Num

ber o

f tes

ts p

ositi

ve (m

ax. 3

0)N

umbe

r of t

ests

pos

itive

(max

. 30)

Num

ber o

f tes

ts p

ositi

ve (m

ax. 1

0)N

umbe

r of t

ests

pos

itive

(max

. 10)

Lots

1 a

nd 2

com

bine

dLo

ts 1

and

2 c

ombi

ned

Lots

1 a

nd 2

com

bine

dLo

ts 1

and

2 c

ombi

ned

Pf o

nly

BION

OTE

MAL

ARIA

P.f.

Ag

Rapi

d Te

st K

itRG

19-1

1Bi

oNot

e, In

c.30

3030

30N

AN

AN

AN

A10

1010

10N

AN

AN

AN

ACa

reSt

art™

Mal

aria

HRP

2/pL

DH (P

f)G0

181/

G018

1-ET

Acce

ss B

io, I

nc.

3030

29 (2

9)30

NA

NA

NA

NA

1010

1010

NA

NA

NA

NA

EzDx

™ M

alar

ia P

f Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

08Ad

vy C

hem

ical

Priv

ate

Lim

ited

3030

3030

NA

NA

NA

NA

1010

1010

NA

NA

NA

NA

Firs

t Res

pons

e® M

alar

ia A

ntig

en P

. fal

cipa

rum

(HRP

2)

Card

Tes

tPI

13FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

3030

3030

NA

NA

NA

NA

1010

1010

NA

NA

NA

NA

Hum

asis

Mal

aria

P.f

Antig

en T

est

ANM

PF-7

025

Hum

asis

Co.

, Ltd

.30

3030

30N

AN

AN

AN

A10

1010

10N

AN

AN

AN

AM

alar

ia A

ntig

en T

est-

PfM

AG01

040

Osca

r Med

icar

e Pv

t. Lt

d.30

3030

30N

AN

AN

AN

A10

1010

10N

AN

AN

AN

AOn

e St

ep M

alar

ia P

.f W

hole

blo

od T

est

W37

-CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

3030

2830

NA

NA

NA

NA

1010

1010

NA

NA

NA

NA

OnSi

te M

alar

ia P

f Ag

Rapi

d Te

stR0

114C

CTK

Biot

ech,

Inc.

3030

3030

NA

NA

NA

NA

1010

1010

NA

NA

NA

NA

Rapi

d 1-

2-3®

Hem

a® C

asse

tte

Mal

aria

PF

MAL

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25

(100

)H

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Diag

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ms

3030

3030

NA

NA

NA

NA

1010

1010

NA

NA

NA

NA

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

(HRP

II)C1

0RH

A25

Rapi

GEN

Inc.

3030

3030

NA

NA

NA

NA

1010

1010

NA

NA

NA

NA

Righ

tSig

n® M

alar

ia P

.f. R

apid

Test

Cas

sett

e (W

hole

Blo

od)

IMPF

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Han

gzho

u Bi

otes

t Bio

tech

Co.

, Ltd

.30

3030

30N

AN

AN

AN

A10

1010

10N

AN

AN

AN

A

SD B

iolin

e M

alar

ia A

g P.

f (H

RP2/

pLDH

)05

FK90

Stan

dard

Dia

gnos

tics,

Inc.

30

(30

/ 28)

b30

(3

0 / 2

8)b

30

(30

/ 27)

b30

(3

0 / 2

0)b

NA

NA

NA

NA

10

(10

/ 10)

b10

(1

0 / 1

0)b

10

(10

/ 10)

b10

(1

0 / 1

0)b

NA

NA

NA

NA

Pf a

nd p

anAT

OMOR

APID

™ M

ALAR

IA (P

F/PA

N)

MM

AL01

Atom

o Di

agno

stic

s PT

Y Li

mite

d30

3030

29 (2

9)0

05

0 (2

9)10

1010

1010

1010

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ONOT

E M

ALAR

IA P

.f &

Pan

Ag

Rapi

d Te

st K

itRG

19-0

8Bi

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e, In

c.30

3030

300

00

010

1010

1010

1010

10Bi

oTra

cer™

Mal

aria

P.f/

PAN

Rap

id C

ard

1701

2Bi

o Fo

cus

Co.,

Ltd.

3030

3030

3027

2820

1010

1010

1010

1010

EzDx

™ M

alar

ia P

an/P

f Rap

id te

st d

etec

tion

Kit

RK M

AL 0

01Ad

vy C

hem

ical

Priv

ate

Lim

ited

3030

3030

19

73

1010

1010

1010

1010

Firs

t Res

pons

e® M

alar

ia A

g. p

LDH/

HRP2

Com

bo C

ard

Test

PI16

FRC

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.30

3030

3029

2730

2110

1010

1010

1010

10H

umas

is M

alar

ia P

.f/Pa

n An

tigen

Tes

tAN

MAL

-702

5H

umas

is C

o., L

td.

3030

3030

00

00

1010

1010

1010

1010

Is It

… M

alar

ia P

f/Pv

Dev

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AL03

0M

edso

urce

Ozo

ne B

iom

edic

als

29 (2

9)30

29 (2

9)29

27 (2

9)20

28 (2

9)11

9 (9

)10

1010

9 (9

)9

109

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.30

3030

3014

2417

010

1010

1010

1010

10On

e St

ep M

alar

ia P

.f/Pa

n W

hole

Blo

od T

est

W62

-CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

3030

3029

00

00

1010

1010

99

107

OnSi

te M

alar

ia P

f/Pa

n Ag

Rap

id T

est

R011

3CCT

K Bi

otec

h, In

c.30

3030

300

02

010

1010

1010

1010

10Pa

rasc

reen

® -

Rapi

d Te

st fo

r Mal

aria

Pan

/Pf

5030

3002

5Ze

phyr

Bio

med

ical

s30

3030

3030

2727

2810

1010

1010

1010

10Qu

ickP

rofil

e™ M

alar

ia P

f/Pa

n Te

st71

063

Lum

iqui

ck D

iagn

ostic

s, In

c.30

3030

3030

2929

3010

1010

1010

1010

10Ra

piG

EN B

IOCR

EDIT

Mal

aria

Ag

Pf/P

an (H

RPII/

pLDH

) C3

0RH

A25

Rapi

GEN

Inc.

3030

3029

01

38

1010

1010

1010

1010

Pf a

nd P

vAd

vanc

ed Q

ualit

y™ O

ne S

tep

Mal

aria

(P

f/Pv

) Tri-

line

Test

(who

le b

lood

)IT

P110

03 T

C40

InTe

c Pr

oduc

ts, I

nc.

2930

3030

NA

NA

NA

NA

1010

1010

NA

NA

NA

NA

BioT

race

r™ M

alar

ia P

.f/P.

v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

3030

3030

NA

NA

NA

NA

1010

1010

NA

NA

NA

NA

Core

test

s® O

ne S

tep

Mal

aria

Pf/

Pv A

g Te

st D

evic

eB4

2-21

/B42

-22

Core

Tec

hnol

ogy

Co.,

Ltd.

3030

3030

NA

NA

NA

NA

1010

1010

NA

NA

NA

NA

EzDx

™ M

alar

ia P

v/Pf

Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

03Ad

vy C

hem

ical

Priv

ate

Lim

ited

3030

3030

NA

NA

NA

NA

1010

1010

NA

NA

NA

NA

(con

tinue

d)


Prod

uct

Prod

uct

code

Man

ufac

ture

r

Posit

ive

test

res

ults

for

P.

fal

cipa

rum

(Pf

line)

Posit

ive

test

res

ults

for

P.

fal

cipa

rum

(pan

line

)Po

sitiv

e te

st r

esul

ts f

or

P. f

alci

paru

m (P

f lin

e)Po

sitiv

e te

st r

esul

ts f

or

P. f

alci

paru

m (p

an li

ne)

200

para

sites

/µL

200

para

sites

/µL

2000

par

asite

s/µL

2000

par

asite

s/µL

Base

line

Room

te

mp

35 °C

45 °C

Base

line

Room

te

mp

35 °C

45 °C

Base

line

Room

te

mp

35 °C

45 °C

Base

line

Room

te

mp

35 °C

45 °C

Num

ber o

f tes

ts p

ositi

ve (m

ax. 3

0)N

umbe

r of t

ests

pos

itive

(max

. 30)

Num

ber o

f tes

ts p

ositi

ve (m

ax. 1

0)N

umbe

r of t

ests

pos

itive

(max

. 10)

Lots

1 a

nd 2

com

bine

dLo

ts 1

and

2 c

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Lots

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com

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Falc

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™ -

Rap

id T

est f

or M

alar

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v/Pf

5030

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5Ze

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med

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3029

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AN

AN

AN

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AN

AN

AN

AFi

rst R

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Mal

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Ag

Pf/P

v Ca

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est

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Prem

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AN

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AN

AH

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3030

3030

NA

NA

NA

NA

1010

1010

NA

NA

NA

NA

KHB®

Mal

aria

Ag

P.f/

P.v

Rapi

d Te

stKH

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7-50

Shan

ghai

Keh

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io-e

ngin

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g Co

., Ltd

.30

3030

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AN

AN

AN

A10

1010

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AN

AN

AN

AM

alar

ia P

V/PF

(pLD

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Ant

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Nan

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Co.

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AN

AN

AN

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AN

AN

AM

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alar

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Diag

nost

ics

Priv

ate

Ltd.

3030

3030

NA

NA

NA

NA

1010

1010

NA

NA

NA

NA

One

Step

Mal

aria

P.f/

P.v

Who

le B

lood

Tes

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056-

CG

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zhou

Won

dfo

Biot

ech

Co.,

Ltd.

3030

3030

NA

NA

NA

NA

1010

1010

NA

NA

NA

NA

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

d Te

stR0

112C

CTK

Biot

ech,

Inc.

3030

3030

NA

NA

NA

NA

9 (9

)10

1010

NA

NA

NA

NA

Quic

kPro

file™

Mal

aria

Pf/

Pv T

est

7105

0Lu

miq

uick

Dia

gnos

tics,

Inc.

3030

3030

NA

NA

NA

NA

1010

1010

NA

NA

NA

NA

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pv

(HRP

II/pL

DH)

C40R

HA2

5Ra

piG

EN In

c.29

(29)

3030

30N

AN

AN

AN

A10

1010

10N

AN

AN

AN

ASD

Bio

line

Mal

aria

Ag

P.f/

P.v

05FK

80St

anda

rd D

iagn

ostic

s, In

c.30

3030

29 (2

9)N

AN

AN

AN

A10

1010

10N

AN

AN

AN

APf

and

Pf

and

Pv

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v05

FK12

0St

anda

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ostic

s, In

c.30

(3

0 / 9

)b30

(3

0 / 2

3)b

30

(30

/ 9)b

30

(30

/ 9)b

NA

NA

NA

NA

10

(10

/ 10)

b10

(1

0 / 1

0)b

10

(10

/ 10)

b10

(1

0 / 1

0)b

NA

NA

NA

NA

NA,

not

app

licab

lePf

, Pla

smod

ium

falc

ipar

um

Pv,

Plas

mod

ium

viv

ax

pan

, Pla

smod

ium

spec

ies

a Po

sitiv

e re

sults

pre

sent

ed in

the

tabl

e ar

e ba

sed

on s

tabi

lity

of a

pos

itive

read

er 1

res

ult

b Pr

oduc

t res

ult s

how

n al

ong

with

resu

lts fo

r HRP

2 ba

nd a

nd P

f-pL

DH b

and,

resp

ectiv

ely

Tabl

e 6a

: Hea

t st

abili

ty t

estin

g re

sult

s fo

r 41

mal

aria

RDT

s on

a c

ultu

red

P. f

alci

paru

m s

ampl

e at

low

(200

) an

d hi

gh (2

000)

par

asit

e de

nsit

y (p

aras

ites

/μL)

. Po

siti

vity

rat

e at

bas

elin

e (r

oom

tem

pera

ture

) an

d af

ter

60 d

ays’

incu

batio

n at

roo

m t

empe

ratu

re, 3

5 °C

and

45

°Ca

(con

tinue

d)

Re

sult

s


Tabl

e 6b

: Hea

t st

abili

ty t

estin

g re

sult

s fo

r 29

com

bina

tion

mal

aria

RDT

s on

a w

ild-t

ype

P. v

ivax

sam

ple

at lo

w (2

00)

and

high

(200

0) p

aras

ite

dens

ity

(par

asit

es/µ

L).

Posi

tivi

ty r

ate

at b

asel

ine

(roo

m t

empe

ratu

re)

and

afte

r 60

day

s’ in

cuba

tion

at r

oom

tem

pera

ture

, 35

°C a

nd 4

5 °C

a

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Posit

ive

test

res

ults

for

P.

viv

ax (P

v lin

e)Po

sitiv

e te

st r

esul

ts f

or

Plas

mod

ium

(pan

line

)Po

sitiv

e te

st r

esul

ts f

or

P. v

ivax

(Pv

line)

Posit

ive

test

res

ults

for

Pl

asm

odiu

m (p

an li

ne)

200

para

sites

/µL

200

para

sites

/µL

2000

par

asite

s/µL

2000

par

asite

s/µL

Base

line

Room

te

mp

35 °C

45 °C

Base

line

Room

te

mp

35 °C

45 °C

Base

line

Room

te

mp

35 °C

45 °C

Base

line

Room

te

mp

35 °C

45 °C

Num

ber o

f tes

ts p

ositi

ve (m

ax. 8

)N

umbe

r of t

ests

pos

itive

(max

. 8)

Num

ber o

f tes

ts p

ositi

ve (m

ax. 4

)N

umbe

r of t

ests

pos

itive

(max

. 4)

Lots

1 a

nd 2

com

bine

dLo

ts 1

and

2 c

ombi

ned

Lots

1 a

nd 2

com

bine

dLo

ts 1

and

2 c

ombi

ned

Pf a

nd p

anAT

OMOR

APID

™ M

ALAR

IA (P

F/PA

N)

MM

AL01

Atom

o Di

agno

stic

s PT

Y Li

mite

dN

AN

AN

AN

A3

57

5N

AN

AN

AN

A4

44

4BI

ONOT

E M

ALAR

IA P

.f &

Pan

Ag

Rapi

d Te

st K

itRG

19-0

8Bi

oNot

e, In

c.N

AN

AN

AN

A6

88

7N

AN

AN

AN

A4

44

4Bi

oTra

cer™

Mal

aria

P.f/

PAN

Rap

id C

ard

1701

2Bi

o Fo

cus

Co.,

Ltd.

NA

NA

NA

NA

88

88

NA

NA

NA

NA

44

44

EzDx

™ M

alar

ia P

an/P

f Rap

id te

st d

etec

tion

Kit

RK M

AL 0

01Ad

vy C

hem

ical

Priv

ate

Lim

ited

NA

NA

NA

NA

88

88

NA

NA

NA

NA

44

44

Firs

t Res

pons

e® M

alar

ia A

g. p

LDH/

HRP2

Com

bo C

ard

Test

PI16

FRC

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.N

AN

AN

AN

A8

88

8N

AN

AN

AN

A4

44

4H

umas

is M

alar

ia P

.f/Pa

n An

tigen

Tes

tAN

MAL

-702

5H

umas

is C

o., L

td.

NA

NA

NA

NA

68

76

NA

NA

NA

NA

44

44

Is It

… M

alar

ia P

f/Pv

Dev

ice

AL03

0M

edso

urce

Ozo

ne B

iom

edic

als

NA

NA

NA

NA

88

88

NA

NA

NA

NA

44

44

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.N

AN

AN

AN

A5

87

2N

AN

AN

AN

A4

44

4On

e St

ep M

alar

ia P

.f/Pa

n W

hole

Blo

od T

est

W62

-CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

NA

NA

NA

NA

20

21

NA

NA

NA

NA

44

44

OnSi

te M

alar

ia P

f/Pa

n Ag

Rap

id T

est

R011

3CCT

K Bi

otec

h, In

c.N

AN

AN

AN

A8

88

8N

AN

AN

AN

A4

44

4Pa

rasc

reen

® -

Rapi

d Te

st fo

r Mal

aria

Pan

/Pf

5030

3002

5Ze

phyr

Bio

med

ical

sN

AN

AN

AN

A8

88

8N

AN

AN

AN

A4

44

4Qu

ickP

rofil

e™ M

alar

ia P

f/Pa

n Te

st71

063

Lum

iqui

ck D

iagn

ostic

s, In

c.N

AN

AN

AN

A8

88

8N

AN

AN

AN

A4

44

4Ra

piG

EN B

IOCR

EDIT

Mal

aria

Ag

Pf/P

an (H

RPII/

pLDH

) C3

0RH

A25

Rapi

GEN

Inc.

NA

NA

NA

NA

88

88

NA

NA

NA

NA

44

44

Pf a

nd P

vAd

vanc

ed Q

ualit

y™ O

ne S

tep

Mal

aria

(P

f/Pv

) Tri-

line

Test

(who

le b

lood

)IT

P110

03 T

C40

InTe

c Pr

oduc

ts, I

nc.

26

67

NA

NA

NA

NA

44

44

NA

NA

NA

NA

BioT

race

r™ M

alar

ia P

.f/P.

v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

88

88

NA

NA

NA

NA

44

44

NA

NA

NA

NA

Core

test

s® O

ne S

tep

Mal

aria

Pf/

Pv A

g Te

st D

evic

eB4

2-21

/B42

-22

Core

Tec

hnol

ogy

Co.,

Ltd.

88

87

NA

NA

NA

NA

44

44

NA

NA

NA

NA

EzDx

™ M

alar

ia P

v/Pf

Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

03Ad

vy C

hem

ical

Priv

ate

Lim

ited

87

53

NA

NA

NA

NA

44

44

NA

NA

NA

NA

Falc

iVax

™ -

Rap

id T

est f

or M

alar

ia P

v/Pf

5030

1002

5Ze

phyr

Bio

med

ical

s8

88

8N

AN

AN

AN

A4

44

4N

AN

AN

AN

AFi

rst R

espo

nse®

Mal

aria

Ag

Pf/P

v Ca

rd T

est

PI19

FRC

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.8

88

8N

AN

AN

AN

A4

44

4N

AN

AN

AN

AH

umas

is M

alar

ia P

.f/P .

v An

tigen

Tes

tAN

MIV

-702

5H

umas

is C

o., L

td.

87

(7)

88

NA

NA

NA

NA

44

44

NA

NA

NA

NA

KHB®

Mal

aria

Ag

P.f/

P.v

Rapi

d Te

stKH

-R-0

7-50

Shan

ghai

Keh

ua B

io-e

ngin

eerin

g Co

., Ltd

.4

86

6N

AN

AN

AN

A4

44

4N

AN

AN

AN

AM

alar

ia P

V/PF

(pLD

H/H

RP2)

Ant

igen

Tes

t In

f-72

Nan

tong

Ege

ns B

iote

chno

logy

Co.

, Ltd

.8

87

2N

AN

AN

AN

A4

44

4N

AN

AN

AN

AM

eris

cree

n M

alar

ia P

f/Pv

Ag

MFL

RPD-

01M

eril

Diag

nost

ics

Priv

ate

Ltd.

15

20

NA

NA

NA

NA

44

44

NA

NA

NA

NA

One

Step

Mal

aria

P.f/

P.v

Who

le B

lood

Tes

tW

056-

CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

00

00

NA

NA

NA

NA

44

44

NA

NA

NA

NA

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

d Te

stR0

112C

CTK

Biot

ech,

Inc.

88

87

NA

NA

NA

NA

44

44

NA

NA

NA

NA

Quic

kPro

file™

Mal

aria

Pf/

Pv T

est

7105

0Lu

miq

uick

Dia

gnos

tics,

Inc.

03

00

NA

NA

NA

NA

44

44

NA

NA

NA

NA

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pv

(HRP

II/pL

DH)

C40R

HA2

5Ra

piG

EN In

c.8

88

8N

AN

AN

AN

A4

44

4N

AN

AN

AN

ASD

Bio

line

Mal

aria

Ag

P.f/

P.v

05FK

80St

anda

rd D

iagn

ostic

s, In

c.8

88

8N

AN

AN

AN

A4

44

4N

AN

AN

AN

APf

, Pf

and

PvSD

Bio

line

Mal

aria

Ag

P.f/

P.f/

P.v

05FK

120

Stan

dard

Dia

gnos

tics,

Inc.

88

7 (7

)8

NA

NA

NA

NA

44

44

NA

NA

NA

NA

NA,

not

app

licab

lePf

, Pla

smod

ium

falc

ipar

um

Pv,

Plas

mod

ium

viv

ax

pan

, Pla

smod

ium

spec

ies

a Po

sitiv

e re

sults

pre

sent

ed in

the

tabl

e ar

e ba

sed

on s

tabi

lity

of a

pos

itive

read

er 1

resu

lt


Figure 20: Heat stability of P. falciparum-specific test line of P. falciparum-only tests against a low-density P. falciparum sample (200 parasites/µL). Positivity rate at baseline and after 60 days’ incubation

OnSite Malaria Pf Ag Rapid Test - R0114C

BIONOTE MALARIA P.f. Ag Rapid Test Kit - RG19-11

CareStartTM Malaria HRP2/pLDH (Pf) - G0181/G0181-ET

EzDxTM Malaria Pf Rapid Malaria antigen detection test - RK MAL 008

First Response® Malaria Antigen P. falciparum (HRP2) Card Test - PI13FRC

Humasis Malaria P.f Antigen Test - ANMPF-7025

Malaria Antigen Test-Pf - MAG01040

One Step Malaria P.f Whole blood Test - W37-C

Rapid 1-2-3® Hema® Cassette Malaria PF - MAL-PF-CAS/25 (100)

RapiGEN BIOCREDIT Malaria Ag Pf (HRPII) - C10RHA25

RightSign® Malaria P.f. Rapid Test Cassette (Whole Blood) - IMPF-C51

SD Bioline Malaria Ag P.f (HRP2/pLDH) - 05FK90 (HRP2 band)

SD Bioline Malaria Ag P.f (HRP2/pLDH) - 05FK90 (Pf LDH band)0

20

30

10

Baseline RT 35 °C 45 °C

No.

of p

ositi

ve re

sults

from

two

lots

a

a Maximum score is 30 (15 tests x 2 lots)

Figure 21: Heat stability of P. falciparum-specific test line of P. falciparum-only tests against a high-density P. falciparum sample (2000 parasites/µL). Positivity rate at baseline and after 60 days’ incubation.

No.

of p

ositi

ve re

sults

from

two

lots

a

Baseline RT 35 °C 45 °C0

2

4

6

8

10 BIONOTE MALARIA P.f. Ag Rapid Test Kit - RG19-11

Rapid 1-2-3® Hema® Cassette Malaria PF - MAL-PF-CAS/25 (100)

OnSite Malaria Pf Ag Rapid Test - R0114C

CareStartTMMalaria HRP2/pLDH (Pf) - G0181/G0181-ET

EzDxTMMalaria Pf Rapid Malaria antigen detection test - RK MAL 008

Humasis Malaria P.f Antigen Test - ANMPF-7025

Malaria Antigen Test-Pf - MAG01040

One Step Malaria P.f Whole blood Test - W37-C

SD Bioline Malaria Ag P.f (HRP2/pLDH) - 05FK90 (Pf LDH band)

SD Bioline Malaria Ag P.f (HRP2/pLDH) - 05FK90 (HRP2 band)

RightSign® Malaria P.f. Rapid Test Cassette (Whole Blood) - IMPF-C51

RapiGEN BIOCREDIT Malaria Ag Pf (HRPII) - C10RHA25

First Response® Malaria Antigen P. falciparum (HRP2) Card Test - PI13FRC

a Maximum score is 10 (5 tests x 2 lots);

Re

sult

s


Figure 22: Heat stability of P. falciparum-specific test line in combination tests against a low-density P. falciparum sample (200 parasites/µL). Positivity rate at baseline and after 60 days’ incubation.

30

20

10

0

No.

of p

ositi

ve re

sults

from

two

lots

a


SD BIOLINE Malaria Antigen Pf/Pv - 05FK80FalciVaxTM Rapid Test for Malaria Pv/Pf - 503010025

One Step Malaria P.f/Pan Whole Blood Test - W62-C

ATOMORAPIDTM Malaria (PF/PAN) - MMAL01

QuickProfileTM Malaria Pf/Pv Test - 71050

KHB® Malaria Ag P.f/P.v Rapid Test - KH-R-07-50

Advanced QualityTM One Step Malaria P.f/P.v Tri-Line Test (whole blood) - ITP11003 TC40

Malaria PV/PF (pLDH/HRP2) Antigen Test - Inf-72

Humasis Malaria P.f/Pan Antigen Test - ANMAL-7025

BIONOTE MALARIA P.f.& Pan Ag Rapid Test Kit - RG19-08

EzDxTM Malaria Pv/Pf Rapid Malaria antigen detection test - RK MAL 003

RapiGEN BIOCREDIT Malaria Ag Pf/Pv (HRPII/pLDH) - C40RHA25

QuickProfileTM Malaria Pf/Pan Test - 71063

RapiGEN BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C30RHA25

Is It… Malaria Pf/Pv Device - AL030

First Response® Malaria Ag. pLDH/HRP2 Combo Card - PI16FRC

SD Bioline Malaria Ag P.f/P.f/P.v - 05FK120 (Pf LDH band)

Meriscreen Malaria Pf/Pv Ag - MFLRPD-01

Humasis Malaria P.f/P.v Antigen Test - ANMIV-7025

Coretests® One Step Malaria Pf/Pv Ag Test Device - B42-21/B42-22

OnSite Malaria Pf/Pv Ag Rapid Test - R0112C

BioTracerTM Malaria P.f/P.v Rapid Card - 17412BioTracerTM Malaria Pf/PAN Rapid Card - 17012

Parascreen® - Rapid Test for Malaria Pan/Pf - 503030025

SD Bioline Malaria Ag P.f/P.f/P.v - 05FK120 (HRP2 band)

OnSite Malaria Pf/Pan Ag Rapid Test - R0113C

First Response® Malaria Ag Pf/Pv Card Test - PI19FRC

One Step Malaria P.f/P.v Whole Blood Test - W056-C

EzDxTM Malaria Pan/Pf Rapid Test Detection kit - RK MAL 001

Meriscreen Malaria Pf/Pan Ag - MHLRPD-01


Figure 23: Heat stability of P. falciparum-specific test line in combination tests against a high-density P. falciparum sample (2000 parasites/µL). Positivity rate at baseline and after 60 days’ incubation.

0

2

4

6

8

10



FalciVaxTM Rapid Test for Malaria Pv/Pf - 503010025


SD BIOLINE Malaria Antigen Pf/Pv - 05FK80



SD Bioline Malaria Ag P.f/P.f/P.v - 05FK120 (HRP2 band)


One Step Malaria P.f/P.v Whole Blood Test - W056-C

BioTracerTM Malaria Pf/PAN Rapid Card - 17012




BioTracerTM Malaria P.f/P.v Rapid Card - 17412









SD Bioline Malaria Ag P.f/P.f/P.v - 05FK120 (Pf LDH band)







No.

of p

ositi

ve re

sults

from

two

lots

a




Figure 24: Heat stability of pan line of combination tests against a low-density P. falciparum sample (200 parasites/µL). Positivity rate at baseline and after 60 days’ incubation.

No.

of p

ositi

ve re

sults

from

two

lots

a


10

20

30 Parascreen® - Rapid Test for Malaria Pan/Pf - 503030025














Figure 25: Heat stability of pan line of combination tests against a high-density P. falciparum sample (2000 parasites/µL). Positivity rate at baseline and after 60 days’ incubation.

0

2

4

6

8

10














No.

of p

ositi

ve re

sults

from

two

lots

a



Figure 26: Heat stability of pan line of combination tests against a low-density P. vivax sample (200 parasites/µL). Positivity rate at baseline and after 60 days’ incubation.

No.

of p

ositi

ve re

sults

from

two

lots

a


2

4

6

8BioTracerTM Malaria Pf/PAN Rapid Card - 17012



QuickProfileTM Malaria Pf/Pan Test - 71063RapiGEN BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C30RHA25




BIONOTE MALARIA P.f.& Pan Ag Rapid Test Kit - RG19-08Humasis Malaria P.f/Pan Antigen Test - ANMAL-7025



One Step Malaria P.f/Pan Whole Blood Test - W62-Ca Maximum score is 8 (4 tests x 2 lots)

Re

sult

s


Figure 28: Heat stability of P. vivax-specific test line in combination tests against a low-density P. vivax sample (200 parasites/µL). Positivity rate at baseline and after 60 days’ incubation.

No.

of p

ositi

ve re

sults

from

two

lots

a


2

4

6

8

BioTracerTM Malaria P.f/P.v Rapid Card - 17412FalciVaxTM Rapid Test for Malaria Pv/Pf - 503010025


One Step Malaria P.f/Pan Whole Blood Test - W62-CQuickProfileTM Malaria Pf/Pv Test - 71050Meriscreen Malaria Pf/Pv Ag - MFLRPD-01






Humasis Malaria P.f/P.v Antigen Test - ANMIV-7025SD Bioline Malaria Ag P.f/P.f/P.v - 05FK120





Figure 29: Heat stability of P. vivax-specific test line in combination tests against a high-density P. vivax sample (2000 parasites/µL). Positivity rate at baseline and after 60 days’ incubation.

0

1

2

3

4

Advanced QualityTM One Step Malaria P.f/P.v Tri-Line Test (whole blood) - ITP11003 TC40BioTracerTM Malaria P.f/P.v Rapid Card - 17412Coretests® One Step Malaria Pf/Pv Ag Test Device - B42-21/B42-22EzDxTM Malaria Pv/Pf Rapid Malaria antigen detection test - RK MAL 003FalciVaxTM Rapid Test for Malaria Pv/Pf - 503010025




SD Bioline Malaria Ag P.f/P.f/P.v - 05FK120


Malaria PV/PF (pLDH/HRP2) Antigen Test - Inf-72KHB® Malaria Ag P.f/P.v Rapid Test - KH-R-07-50





No.

of p

ositi

ve re

sults

from

two

lots

a



Figure 27: Heat stability of pan line of combination tests against a high-density P. vivax sample (2000 parasites/µL). Positivity rate at baseline and after 60 days’ incubation

0

1

2

3

4




QuickProfileTM Malaria Pf/Pan Test - 71063RapiGEN BIOCREDIT Malaria Ag Pf/Pan (HRPII/pLDH) - C30RHA25









No.

of p

ositi

ve re

sults

from

two

lots

a

Baseline RT 35 °C 45 °Ca Maximum score is 4 (2 tests x 2 lots)


14. eAse-of-use descrIptIon And AnomAlIes

14.1. ease of useAfter becoming proficient in using a product, two technicians produced a joint agreed assessment of product usability. The results, which are a description of the product with emphasis on aspects considered important for ease of use in the field, are presented in Table 7. It is important to note that the assessment does not include a comparison of blood transfer devices, which are critical to both the safety and the accuracy of the testing procedure and pose a significant challenge to many users. These may vary for manufacturers with many products. Procurement decisions should be based on which transfer devices are best suited for the intended users, and this should be discussed with the manufacturer before procurement. It is strongly recommended that RDT packaging, contents, safety and ease of use be assessed in the field as part of the product selection process (Annex S2, Table AS2.1).

14.2. AnomaliesIn round 6, technicians regularly recorded specific observa-tions (or anomalies) based on a list of problems encountered with some production lots evaluated in past rounds of testing and at WHO–FIND lot testing laboratories. Since March 2012, these observations have been included in all WHO–FIND lot testing reports and were recorded as part of product testing for the first time in round 5. Table 8 shows the percentage of tests per product for which specific anomalies were observed and the frequency of tests with an anomaly for each product. Generally, users should be aware of major anomalies that may be encountered in production lots (Fig. AS2.1), as they can affect interpretation of RDT results. Each round-6 product had one to six anomalies (Table 8). Incomplete clearing and red background were the most commonly observed anomalies, seen in 95% and 85% of products, respectively. Failed migra-tion, incomplete migration and patchy broken test lines were the next most regularly reported, seen in 34%, 32% and 37% of products, respectively. Overall, approximately half the products had a frequency of anomalies > 2% (Fig. 30).

Figure 30: Percentage of RDTs with various anomalies observed in production lots

100

80

60

40

20

0

Perc

enta

ge o

f pro

duct

s

Type of anomaly

Re

sult

s


Tabl

e 7:

Eas

e-of

-use

des

crip

tion

of 4

1 m

alar

ia R

DTs

incl

uded

in r

ound

6: W

HO

mal

aria

RDT

pro

duct

tes

ting

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Bloo

d sa

fety

aIn

stru

ctio

n qu

ality

b

Combined score (max. 5) Number of timed steps Total time to resultDesiccant with color indicator (yes/no)

Buff

er

Blood transfer device

Format

Language of instruction

Item

s in

clud

ed in

RDT

box

c

Mixing wells involved Retractable needle

Strip exposed

Score (max. 3)

No diagram

Diagram of result(1)Diagram of result & method (2)

Score (max. 2)

Container does not punctureDoes not flow freelyinsufficient volume empty (bottle or vial)

discoloured

Pf o

nly

BION

OTE

MAL

ARIA

P.f.

Ag

Rapi

d Te

st K

itRG

19-1

1Bi

oNot

e, In

c.1

NA

12

22

41

20no

pipe

tte

cass

ette

Engl

ish

cass

ette

/IFU

/buf

fer b

ottle

Care

Star

t™ M

alar

ia H

RP2/

pLDH

(Pf)

G018

1/G0

181-

ETAc

cess

Bio

, Inc

.1

01

22

24

120

nopi

pett

eca

sset

teEn

glis

hca

sset

te/IF

U/b

uffe

r bot

tle/a

lcoh

ol

swab

/ la

ncet

EzD

x™ M

alar

ia P

f Ra

pid

Mal

aria

ant

igen

de

tect

ion

test

RK M

AL 0

08Ad

vy C

hem

ical

Priv

ate

Limite

d1

01

22

24

120

nopi

pett

eca

sset

teEn

glis

hca

sset

te/IF

U/b

uffe

r bot

tle/a

lcoh

ol

swab

/ la

ncet

Firs

t Res

pons

e® M

alar

ia A

ntig

en P.

falci

paru

m

(HRP

2) C

ard

Test

PI13

FRC

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.1

01

22

24

120

nopi

pett

eca

sset

teEn

glis

hca

sset

te/IF

U/b

uffe

r bot

tle/a

lcoh

ol

swab

/ la

ncet

Hum

asis

Mal

aria

P.f

Antig

en T

est

ANM

PF-7

025

Hum

asis

Co.

, Ltd

.1

01

22

24

120

noin

vert

ed

cup

cass

ette

Engl

ish,

Fr

ench

, Sp

anis

h

cass

ette

/IFU

/buf

fer b

ottle

/alc

ohol

sw

ab /

lanc

et

Mal

aria

Ant

igen

Tes

t-Pf

MAG

0104

0Os

car M

edic

are

Pvt.

Ltd.

1N

A1

22

24

130

nopi

pett

eca

sset

teEn

glis

hca

sset

te/IF

U/b

uffe

r bot

tle

One

Step

Mal

aria

P.f

Who

le b

lood

Tes

tW

37-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.1

01

22

24

115

nopi

pett

eca

sset

teEn

glis

hca

sset

te/IF

U/b

uffe

r bot

tle/a

lcoh

ol

swab

/ la

ncet

OnSi

te M

alar

ia P

f Ag

Rapi

d Te

stR0

114C

CTK

Biot

ech,

Inc.

1N

A1

22

24

130

nopi

pett

eca

sset

teEn

glis

hca

sset

te/IF

U/b

uffe

r bot

tle

Rapi

d 1-

2-3®

Hem

a® C

asse

tte

Mal

aria

PF

MAL

-PF-

CAS/

25

(100

)H

ema

Diag

nost

ic S

yste

ms

10

12

11

31

20no

loop

cass

ette

Engl

ish

cass

ette

/IFU

/buf

fer b

ottle

/alc

ohol

sw

ab /

lanc

etRa

piG

EN B

IOCR

EDIT

Mal

aria

Ag

Pf (H

RPII)

C10R

HA2

5Ra

piG

EN In

c.1

01

22

24

130

nopi

pett

eca

sset

teEn

glis

hca

sset

te/IF

U/b

uffe

r bot

tleRi

ghtS

ign®

Mal

aria

P.f.

Rap

id T

est

Cass

ette

(W

hole

Blo

od)

IMPF

-C51

Han

gzho

u Bi

otes

t Bi

otec

h Co

., Lt

d.1

NA

12

22

41

10no

pipe

tte

cass

ette

Engl

ish

cass

ette

/IFU

/buf

fer b

ottle

SD B

iolin

e M

alar

ia A

g P.

f (H

RP2/

pLDH

)05

FK90

Stan

dard

Dia

gnos

tics,

Inc.

10

12

22

41

15ye

spi

pett

eca

sset

teEn

glis

h,

Fren

chca

sset

te/IF

U/b

uffe

r bot

tle/a

lcoh

ol

swab

/ la

ncet

Pf a

nd p

an

ATOM

ORAP

ID™

MAL

ARIA

(PF/

PAN

)M

MAL

01At

omo

Diag

nost

ics P

TY Li

mite

d1

11

32

25

115

noco

llect

ion

arm

cass

ette

Engl

ish

cass

ette

/IFU

/buf

fer b

ottle

BION

OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kit

RG19

-08

BioN

ote,

Inc.

1N

A1

22

24

120

nopi

pett

eca

sset

teEn

glis

hca

sset

te/IF

U/b

uffe

r bot

tleBi

oTra

cer™

Mal

aria

P.f/

PAN

Rap

id C

ard

1701

2Bi

o Fo

cus

Co.,

Ltd.

1N

A1

22

24

120

nolo

opca

sset

teEn

glis

hca

sset

te/IF

U/b

uffe

r bot

tleEz

Dx™

Mal

aria

Pan

/Pf R

apid

test

det

ectio

n Ki

tRK

MAL

001

Advy

Che

mic

al P

rivat

e Lim

ited

10

12

22

41

20no

pipe

tte

cass

ette

Engl

ish

cass

ette

/IFU

/buf

fer b

ottle

/alc

ohol

sw

ab /

lanc

etFi

rst

Resp

onse

® M

alar

ia A

g. p

LDH

/HRP

2 Co

mbo

Car

d Te

stPI

16FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

10

12

22

41

20no

pipe

tte

cass

ette

Engl

ish

cass

ette

/IFU

/buf

fer b

ottle

/alc

ohol

sw

ab /

lanc

et

Hum

asis

Mal

aria

P.f/

Pan

Antig

en T

est

ANM

AL-7

025

Hum

asis

Co.

, Ltd

.1

01

22

24

120

noin

vert

ed

cup

cass

ette

Engl

ish,

Fr

ench

, Sp

anis

h

cass

ette

/IFU

/buf

fer b

ottle

/alc

ohol

sw

ab /

lanc

et

Is It

… M

alar

ia P

f/Pv

Dev

ice

AL03

0M

edso

urce

Ozo

ne B

iom

edic

als

1N

A1

21

13

120

noX

Xlo

opca

sset

teEn

glis

hca

sset

te/IF

U/b

uffe

r bot

tleM

eris

cree

n M

alar

ia P

f/Pa

n Ag

M

HLR

PD-0

1M

eril

Diag

nost

ics P

rivat

e Lt

d.1

NA

12

11

31

20no

pipe

tte

cass

ette

Engl

ish

cass

ette

/IFU

/buf

fer b

ottle

One

Step

Mal

aria

P.f/

Pan

Who

le B

lood

Tes

tW

62-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.1

01

22

24

115

nopi

pett

eca

sset

teEn

glis

hca

sset

te/IF

U/b

uffe

r bot

tle/a

lcoh

ol

swab

/ la

ncet

OnSi

te M

alar

ia P

f/Pa

n Ag

Rap

id T

est

R011

3CCT

K Bi

otec

h, In

c.1

NA

12

22

41

30no

pipe

tte

cass

ette

Engl

ish

cass

ette

/IFU

/buf

fer b

ottle

Para

scre

en®

- Ra

pid

Test

for M

alar

ia P

an/P

f50

3030

025

Zeph

yr B

iom

edic

als

10

12

22

41

20no

Xlo

opca

sset

teEn

glis

hca

sset

te/IF

U/b

uffe

r bot

tle/a

lcoh

ol

swab

/ la

ncet

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

Dia

gnos

tics,

Inc.

10

12

22

41

20no

Xpi

pett

eca

sset

teEn

glis

hca

sset

te/IF

U/b

uffe

r bot

tleRa

piGE

N B

IOCR

EDIT

Mal

aria

Ag

Pf/P

an (H

RPII/

pLDH

) C3

0RH

A25

Rapi

GEN

Inc.

10

12

22

41

30no

pipe

tte

cass

ette

Engl

ish

cass

ette

/IFU

/buf

fer b

ottle


Prod

uct

Prod

uct

code

Man

ufac

ture

r

Bloo

d sa

fety

aIn

stru

ctio

n qu

ality

b

Combined score (max. 5) Number of timed steps Total time to resultDesiccant with color indicator (yes/no)

Buff

er

Blood transfer device

Format

Language of instruction

Item

s in

clud

ed in

RDT

box

c

Mixing wells involved Retractable needle

Strip exposed

Score (max. 3)

No diagram

Diagram of result(1)Diagram of result & method (2)

Score (max. 2)

Container does not punctureDoes not flow freelyinsufficient volume empty (bottle or vial)

discoloured

Pf a

nd P

vAd

vanc

ed Q

ualit

y ™

One

Step

Mal

aria

(Pf

/Pv)

Tr

i-lin

e Te

st (w

hole

blo

od)

ITP1

1003

TC4

0In

Tec

Prod

ucts

, Inc

.1

01

22

24

115

nopi

pett

eca

sset

teEn

glis

hca

sset

te/IF

U/b

uffe

r bot

tle

BioT

race

r™ M

alar

ia P

.f/P.

v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

1N

A1

22

24

120

nolo

opca

sset

teEn

glis

hca

sset

te/IF

U/b

uffe

r bot

tleCo

rete

sts®

One

Ste

p M

alar

ia P

f/Pv A

g Te

st D

evice

B42-

21/B

42-2

2Co

re T

echn

olog

y Co

., Lt

d.1

01

21

13

115

noX

pipe

tte

cass

ette

Engl

ish

cass

ette

/IFU

/buf

fer b

ottle

EzDx

™ M

alar

ia P

v/Pf

Rap

id M

alar

ia a

ntig

en

dete

ctio

n te

stRK

MAL

003

Advy

Che

mic

al P

rivat

e Lim

ited

10

12

22

41

20no

pipe

tte

cass

ette

Engl

ish

cass

ette

/IFU

/buf

fer b

ottle

/alc

ohol

sw

ab /

lanc

et

Falc

iVax

™ -

Rap

id T

est f

or M

alar

ia P

v/Pf

5030

1002

5Ze

phyr

Bio

med

ical

s1

01

22

24

120

noX

loop

cass

ette

Engl

ish

cass

ette

/IFU

/buf

fer b

ottle

/alc

ohol

sw

ab /

lanc

et

Firs

t Res

pons

e® M

alar

ia A

g Pf

/Pv

Card

Tes

tPI

19FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

10

12

22

41

30no

pipe

tte

cass

ette

Engl

ish

cass

ette

/IFU

/buf

fer b

ottle

/alc

ohol

sw

ab /

lanc

et

Hum

asis

Mal

aria

P.f/

P.v

Antig

en T

est

ANM

IV-7

025

Hum

asis

Co.

, Ltd

.1

01

22

24

120

noin

vert

ed

cup

cass

ette

Engl

ish,

Fr

ench

, Sp

anis

h

cass

ette

/IFU

/buf

fer b

ottle

/alc

ohol

sw

ab /

lanc

et

KHB®

Mal

aria

Ag

P.f/

P.v

Rapi

d Te

stKH

-R-0

7-50

Shan

gh

ai

Keh

ua

Bio

-en

gine

erin

g Co

., Lt

d.1

11

32

24

115

nopi

pett

eca

sset

teEn

glis

hca

sset

te/IF

U/b

uffe

r bot

tle/a

lcoh

ol

swab

/ la

ncet

Mal

aria

PV/

PF (p

LDH

/HRP

2) A

ntig

en T

est

Inf-

72N

anto

ng E

gens

Bio

tech

nolo

gy

Co.,

Ltd.

1N

A1

22

24

120

nopi

pett

eca

sset

teEn

glis

hca

sset

te/IF

U/in

divi

dual

buf

fer

vial

s/al

coho

l sw

ab /

lanc

etM

eris

cree

n M

alar

ia P

f/Pv

Ag

MFL

RPD-

01M

eril

Diag

nost

ics P

rivat

e Lt

d.1

NA

12

11

31

20no

pipe

tte

cass

ette

Engl

ish

cass

ette

/IFU

/buf

fer b

ottle

One

Step

Mal

aria

P.f/

P.v

Who

le B

lood

Tes

tW

056-

CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

10

12

22

41

15no

pipe

tte

cass

ette

Engl

ish

cass

ette

/IFU

/buf

fer b

ottle

/alc

ohol

sw

ab /

lanc

etOn

Site

Mal

aria

Pf/

Pv A

g Ra

pid

Test

R011

2CCT

K Bi

otec

h, In

c.1

NA

12

22

41

30no

pipe

tte

cass

ette

Engl

ish

cass

ette

/IFU

/buf

fer b

ottle

Quic

kPro

file™

Mal

aria

Pf/

Pv T

est

7105

0Lu

miq

uick

Dia

gnos

tics,

Inc.

10

12

22

41

20no

Xpi

pett

eca

sset

teEn

glis

hca

sset

te/IF

U/b

uffe

r bot

tleRa

piG

EN B

IOCR

EDIT

Mal

aria

Ag

Pf/P

v (H

RPII/

pLDH

)C4

0RH

A25

Rapi

GEN

Inc.

10

12

22

41

30no

pipe

tte

cass

ette

Engl

ish

cass

ette

/IFU

/buf

fer b

ottle

SD B

iolin

e M

alar

ia A

g P.

f/P.

v05

FK80

Stan

dard

Dia

gnos

tics,

Inc.

10

12

22

41

15ye

spi

pett

eca

sset

teEn

glis

h,

Fren

chca

sset

te/IF

U/b

uffe

r bot

tle/a

lcoh

ol

swab

/ la

ncet

Pf a

nd P

f an

d Pv

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v 05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.1

01

22

24

115

yes

pipe

tte

cass

ette

Engl

ish,

Fr

ench

cass

ette

/IFU

/buf

fer b

ottle

/alc

ohol

sw

ab /

lanc

etPf

, Plas

mod

ium

falc

ipar

um

Pv,

Plas

mod

ium

viv

ax

pan

, Pla

smod

ium

spec

ies

IF

U, in

stru

ctio

ns fo

r use

a M

ixin

g w

ells

invo

lved

; Yes

=0; N

o=1;

retr

acta

ble

need

le:y

es=1

; no=

0; s

trip

exp

osed

, not

with

in c

ard

or c

asse

tte:

exp

osed

=0,

cov

ered

=1b

No

diag

ram

s=0;

dia

gram

of r

esul

ts=1

; dia

gram

of r

esul

t and

met

hod=

2c

Proc

urer

s sh

ould

ver

ify w

hich

acc

esso

ries

acco

mpa

ny te

st k

its w

ith th

e m

anuf

actu

rer a

nd e

nsur

e th

ey p

rocu

re th

e ap

prop

riate

pro

duct

s.

Tabl

e 7:

Eas

e-of

-use

des

crip

tion

of 4

1 m

alar

ia R

DTs

incl

uded

in r

ound

6: W

HO

mal

aria

RDT

pro

duct

tes

ting

(con

tinue

d)

Re

sult

s


Tabl

e 8:

Per

cent

age

dist

ribut

ion

of a

nom

alie

s ob

serv

ed b

y pr

oduc

t in

pha

se 2

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Perc

enta

ge

of t

ests

w

ith a

t le

ast

one

anom

aly

Perc

enta

ge o

f te

sts

with

spe

cifie

d an

omal

y

Red

back

grou

nd

Red

back

grou

nd

obsu

ring

test

line

(s)

Inco

mpl

ete

clea

ring

Inco

mpl

ete

mig

ratio

nFa

iled

mig

ratio

n

Strip

m

ispla

ced

in c

asse

tte

(shi

ft)

Ghos

t te

st

lines

Diff

use

test

line

s

Patc

hy

brok

en

test

line

Othe

r

Pf o

nly

BION

OTE

MAL

ARIA

P.f.

Ag

Rapi

d Te

st K

itRG

19-1

1Bi

oNot

e, In

c.0.

50.

00.

00.

30.

00.

00.

00.

00.

00.

20.

0Ca

reSt

art™

Mal

aria

HRP

2/pL

DH (P

f)G0

181/

G018

1-ET

Acce

ss B

io, I

nc.

0.7

0.1

0.0

0.6

0.0

0.0

0.0

0.0

0.0

0.0

0.0

EzDx

™ M

alar

ia P

f Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

08Ad

vy C

hem

ical

Priv

ate

Lim

ited

2.0

0.7

0.0

1.3

0.0

0.1

0.0

0.0

0.0

0.0

0.0

Firs

t Res

pons

e® M

alar

ia A

ntig

en P

. fal

cipa

rum

(HRP

2)

Card

Tes

tPI

13FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

1.5

0.5

0.0

1.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

Hum

asis

Mal

aria

P.f

Antig

en T

est

ANM

PF-7

025

Hum

asis

Co.

, Ltd

.0.

20.

00.

00.

20.

00.

00.

00.

00.

00.

00.

0M

alar

ia A

ntig

en T

est-

PfM

AG01

040

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Dis

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15. dIscussIon of key fIndIngs

This report describes the performance of many of the available malaria antigen-detecting RDTs manufactured under the ISO 13485:2003 quality standard. Malaria RDTs can greatly improve the management of febrile illness in malaria-endemic areas. To be useful in this context, they must have adequate:

• sensitivity, to detect nearly all clinically significant cases of malaria;

• specificity, to accurately discriminate non-malarial febrile illness from malaria, to ensure appropriate management and accurate disease monitoring;

• stability, to maintain accuracy after transport and storage in ambient conditions; and

• ease-of-use and safety, to allow safe, correct preparation and accurate interpretation of results.

Malaria RDTs were evaluated in terms of these four major requirements in order to assist national malaria control programmes and other procurement agencies in selecting products appropriate for their needs. The panel used allowed successful discrimination between the RDTs evaluated, which had a range of performance. A number of products showed a high rate of antigen detection combined with a low false-positive rate and good heat (thermal) stability. These attributes are essential if the tests are to be relied upon as a basis for decisions about malaria treatment in the populations of most malaria-endemic countries.

Overall, the mean product PDS against low-density P. falci-parum samples in round 6 was 83.6%, slightly higher than in round 5 (81.0%) but suggesting that performance may be plateauing after several rounds of improvement1. For P. vivax, the mean PDS of 70.7% is the highest achieved so far2. The median false-positive rate was 0.5%, which is a slight improvement over previous rounds. Overall, a high level of performance has been maintained in P. falciparum-only tests and improved performance has been seen in P. vivax-detecting RDTs.

Two products tested in round 2 of the programme were resubmitted for testing in round 6. Their performance was comparable 5 years after initial testing, both products fulfilling the WHO procurement criteria in both rounds.

The evaluation is performed against a standardized panel of cultured P. falciparum and frozen blood samples by expe-rienced technicians in a research laboratory and is not therefore a field evaluation of the accuracy of RDTs in a specific epidemiological context in the hands of the intended users. The panel is designed to mimic fresh blood samples from actual cases as closely as possible, while allowing direct

1 PDS for P. falciparum in rounds 1, 2, 3 and 4 was 67.2%, 69.9%, 75.5% and 81.6%, respectively.

2 PDS for P. vivax in rounds 1, 2, 3 , 4 and 5 was 36.0%, 58.9%, 47.1%, 51.3% and 61.3%, respectively.

comparison of a large number of products simultaneously with control for confounding factors and is calibrated to a level likely to discriminate differences in the performance of various products. The discussion points below should therefore be taken into account in interpreting the results.

15.1. panel detection score and its relation to sensitivity Evaluation of the RDTs against the phase-2 wild-type parasite panel with a parasite density of 200 parasites/µL (Figs 10 and 11) revealed a range of frequency and consistency of antigen detection between products, recorded as the PDS. As expected, testing at higher parasite density (2000 or 5000 parasites/µL) resulted in smaller differences in performance. As two tests from two different lots were tested at 200 parasites/µL and as all four results had to be positive in order for a sample to be considered detected by an RDT, a positive result indicated the ability of a product to detect the target antigen in the sample and to do this consistently (both tests from both lots). A parasite density of about 200 parasites/µL should be detected to ensure high field sensitivity for clinically significant malaria infection in many malaria-endemic populations (10).

The PDS in the panels used in this evaluation differs from the test sensitivity in clinical settings for five main reasons.

(i) The performance of different lots or batches of the same product may vary. Variation in lot performance is an issue for all diagnostics; therefore, the results found in the evaluation may not predict the results for subsequent RDT lots. It is important to test lots before their distribution in the field to ensure that the expected performance is maintained (section 16.2).

(ii) In clinical settings, patients show wide variation in parasite density, the range depending on the local epidemiology of the disease. The parasite density in the population tested affects the clinical sensitivity of a test. The PDS against a test panel of blood samples diluted to 200 parasites/µL is likely to underestimate the clinical sensitivity of an RDT in areas where symptomatic patients have much higher parasite densities. Many tests that show only moderate detection of the 200-parasites/µL panel may perform well in such settings, as indicated by the better PDS of most products against the panel at 2000 parasites/µL. The small differences in PDS seen in Figs S1, S2 and 9–11 and Tables 4 and 5 found among the better-performing RDTs in this evaluation are unlikely to result in noticeable differences in clinical sensitivity,andotherissues,suchasrequiredstorageconditions, stability, cost, experience and training of the intended users, ease of use (Annex S2) and manufacturingcapacity,maybeequallyimportantin test selection. Consideration of the parasite density


in target populations and the probable sensitivity of RDTs in the field indicates that, even in areas with high transmission and strong malaria immunity, the popula-tion may include individuals with a low parasite density but clinically significant infection (e.g. young children, pregnant women, people who regularly use bed nets, immigrants and people with reduced immunity). The ability to detect low parasite-density infections reliably, therefore, remains important. As some countries move towards elimination of malaria, population immunity will decrease and/or clinical cases may be detected earlier, and it will become increasingly important to use diagnostic tests that detect low parasite density (i.e. with a high PDS against samples with 200 parasites/µL).

(iii) The performance of tests against the challenge panel may not always predict sensitivity in clinical testing, e.g. when antigen expression by certain parasite populations differs greatly from that in the panel. For example, P. falciparum strains in some areas of India and South America do not express HRP2 antigens because of gene deletions (11–12). If a significant proportion of parasites in a given area do not express HRP2 and HRP3, tests to detect other target antigens (e.g. pLDH or aldolase) must be used. To date, parasite populations with a high frequency of non-expression of target antigens have not been identified elsewhere than in South America1.

(iv) The conditions under which RDTs are transported and stored can alter their sensitivity in the field. The tests evaluated in round 6 were shipped and stored under conditions intended to safeguard them from degradation by high temperature or other extreme conditions. If such precautions are not taken with purchased RDTs, loss of performance could result. The ambient temperature of storage conditions varies widely in the settings in which these tests are commonly used, as does the temperature during transport; therefore, the requirements for the heat stability of a product will differ. Tests should be transported and stored well within the temperature range recommended by the manufacturer (see Annex 1) and extremes of temperature avoided (31–32).

(v) Diagnostic sensitivity and specificity depend on the quality of preparation and interpretation of the tests. Highly trained technicians tested all the products in this evaluation. In clinical settings, malaria RDTs are often used by health workers with limited training and supervision; therefore, simple design and clearly interpretable results are required to ensure translation of the technical proficiency of a product into accurate diagnoses in the field (33).

1 Cheng Q, Gatton M, Barnwell J, et al. Plasmodium falciparum parasites lacking histidine-rich protein 2 and 3: a review and recommendations for accurate reporting. Published in Malaria Journal.

15.2. false-positive rate and specificity False-positive rates are reported against a panel of 52 clean-negative samples taken from blood donated in low-transmission settings by people without symptoms of malaria. In addition, false-positive rates were calculated with a smaller number of samples with specific characteristics that affect the likelihood of a false-positive result from an immunodiagnostic test (e.g. rheumatoid factor, anti-nuclear antibody) or that may be significant in a specific population in a malaria-endemic area (e.g. leishmaniasis, dengue). The importance of these results depends on the intended area of use. High false-positive rates with samples of blood from dengue patients, for example, might not be a significant factor in regions in which dengue does not occur. In view of the small number of samples in each category in this evaluation, the results should be considered primarily a guide to potential cross-reactions, which should be closely monitored if they are relevant to the target population.

In general, it is preferable to procure a product with a low rate of false-positive reactions. In the case of many diagnostic tests, a trade-off must be made between a preference for a high rate of antigen detection (sensitivity) and a low false-positive rate (specificity). The context in which the test will be used will guide the relative importance of these two factors in the choice of one product over another. Overall, in this evaluation, there was no correlation between a lower PDS (loss of sensitivity) and a low false-positive rate (high specificity). A number of products had both a high PDS and a low false-positive rate.

15.3. reactivity of combination Hrp2 and pan-pldH test lines against P. falciparum samplesInstructions for the use of P. falciparum/pan and pan/P. falci-parum combination tests classify P. falciparum infections as either HRP2 test line-positive alone or in combination with the pan-pLDH line. Combination tests that return only a positive HRP2 test line may be incorrectly interpreted as false positives for malaria infection secondary to persistent (HRP2) antigenaemia. The results in this report clearly indicate that most combination tests in which HPR2 is used for the detection of P. falciparum return positive results only on the HRP2 band at lower densities of P. falciparum (Table A4.2). When both the HRP2 and the pan test bands were positive, the mean band intensity was significantly lower on the pan test band than on the HRP2 test band. Therefore, it is important to reinforce adherence to the manufacturer’s instructions for use (Annex 2) and to emphasize that for combination HRP2/pan-pLDH tests, a HRP2 test line-positive alone may well be attributed to the poor reactivity of pan-pLDH lines.

Dis

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15.4. Heat (thermal) stability In this round, heat stability of P. vivax detecting test lines was assessed against a wild-type P. vivax sample for the first time. The RDTs evaluated were held for 2 months at room temperature (21–25 °C) and at 35 °C and 45 °C at 75% humidity and tested to evaluate stability at these tempera-tures as compared with baseline detection. The importance of thermal stability depends on the conditions under which a product will be transported and stored. Thus, stability at high temperatures is vital if an RDT is to be stored at clinics in a country where the ambient temperature can reach 45 °C in the hot season but is less critical in a high-altitude or cooler environment where the temperature rarely rises above 35 °C. Many commercially available RDTs indicate 30 °C or 40 °C as the maximal storage temperature (Annex 1). Higher temperatures were tested in this evaluation because malaria-endemic countries often have maximum ambient temperatures of 35 °C, although use of cool storage can allow storage of products below this temperature. When RDTs are likely to be transported and stored at high ambient temperatures, heat (thermal) stability must be considered a significant factor in ensuring sensitivity.

High humidity accelerates the degradation of malaria RDTs and other lateral flow tests. All the products in this evaluation were packaged in individual envelopes containing desiccant and designed to be moisture-proof. This allows the user to open the envelope of a test at the time of use, limiting exposure to high humidity. During the stability-testing phase of this evaluation, the RDTs were stored at 75% humidity. The packaging should, if in good condition, protect the contents from exposure to high humidity during storage. The results presented here provide an assessment of both the stability of the RDT and the quality of its packaging.

Several P. falciparum detecting products showed high stability at the temperatures and times used in the evaluation. In general, in this round, as in previous ones, pan-specific lines (pLDH) performed less well at baseline and were less stable than HRP2 test lines, so that it was difficult to assess post-incubation stability. When tested against P. vivax, approximately half the pan-pLDH lines had high stability at all temperatures and times tested. While some products showed high stability on their P. vivax pLDH lines, they were generally less stable, performing less well at baseline and therefore making it difficult to assess stability after incubation.

While the temperature and humidity were held constant in this evaluation, temperatures in the field fluctuate with the time of day and season. Two months’ storage at a set tempera-ture cannot accurately predict long-term stability under field conditions, but loss of sensitivity for parasite detection over this period indicates that significant sensitivity will be lost if RDTs are stored at similar or higher temperatures for a significant period of their storage time and the likelihood of greater susceptibility to degradation during short exposure to much higher temperatures, such as during transport (34, 35).

15.5. ease-of-use description The sensitivity and specificity of RDTs depend on the quality of preparation and interpretation. In general, a simpler format with fewer steps or fewer required extraneous materials is likely to be prepared and interpreted more reliably. Thus, cassette-format RDTs are generally more reliably prepared and interpreted than products in dipstick format (36). The extra cost of this format may be offset by the advantages of greater accuracy and, in some cases, less additional equipment required to perform them.

The method by which blood is transferred from the patient to the test is important for the safety of the user and for the accuracy of the volume transferred. Devices for blood transfer are supplied with RDTs but vary widely in design and accuracy (30). The performance of blood transfer devices was not formally assessed in this evaluation, as blood was transferred from a tube with a micropipette to ensure that the volume specified by the manufacturer was used. Procurement programmes for RDTs should consider the adequacyofthebloodtransferdevicesupplied,includingthe experience of health workers and the cost and time requiredforretraining.It may be appropriate to discuss with manufacturers the possibility of changing the blood transfer device from that usually supplied.

The clarity of results is important for interpreting tests. A clearly visible (intense) test line is less likely to be overlooked than a line that is barely visible. While reading proficiency and adequate workplaces should be ensured, some health workers might have suboptimal vision or work in inadequate lighting. The intensity of the line of the test band was found to be closely associated with the PDS achieved by RDTs (Tables A4.2 and A4.3).

The importance of format and the simplicity of the test design depend on the intended users. Trained laboratory technicians can handle a complicated procedure more reli-ably than village volunteers with limited supervision. In all cases, proficiency-based training and adequate supervision should be included in any RDT-based diagnostic programme, and clear instructions should be provided in a language and format appropriate for the user (37, 38). Annex S2 provides guidance on conducting a field-based ease-of-use assess-ment (Table AS3.1).


15.6. rdt anomalies in production lotsIn the production lots submitted for evaluation, anomalies that affected interpretation of the results were encountered with variable frequency. On the basis of the experience of several rounds of product testing, with 4095 lots tested in the WHO–FIND lot testing programme, a glossary of RDT anomalies has been prepared (Fig. AS2.1). This glossary may be used in RDT training programmes to illustrate potential problems with some production lots and how to report them accurately. As many of the anomalies are infrequent, they might not be picked up in manufacturers’ quality control or lot release procedures; therefore, this information is also useful for manufacturers that wish to improve their processes.

15.7. Inter-lot variation The testing programme evaluated only two production lots of each product. Malaria RDTs are complex biological products made up of components that are commonly supplied from different sources and are subject to a variety of conditions during manufacture that may affect the quality of the final product. All manufacturers that entered this evaluation provided at least one current ISO 13485:2003 certificate for a manufacturing facility. This standard is designed to ensure consistency in the quality of the final product, if correctly implemented. The results presented here indicate that inter-lot variation does occur, and WHO strongly recommends that a sample of RDTs from each production lot be tested before their dissemination to the field, to ensure that they meet an appropriate standard. This can be facilitated by WHO through two WHO-recognized lot testing facilities (section 16.2).

Inter-test variation will be detected to some extent by routine lot testing. Ensuring that manufacturers follow good manufacturing standards should minimize the likelihood of inconsistencies due to poor practice in the manufacturing process. Culture-based panels that are subsets of the phase-1 panel used in this evaluation are available as reference standards for manufacturers against which to set their lot-release criteria1.

1 http://www.who.int/malaria/areas/diagnosis/rapid-diagnostic-tests/malaria_specimen_bank/en/

15.8. target antigens and speciesThe malaria RDTs assessed in this evaluation detect one or more of three parasite antigens, HRP2, pLDH and aldolase, in various combinations. HRP2 is present only in P. falciparum, whereas aldolase and pLDH are present in all four species and may be used as pan or all-species targets. Some tests use differences in pLDH sequences between species as a means to differentiate P. falciparum from P. vivax and other species. There is considerable overlap in the PDS of products that target the different antigens in this evaluation. While the products with the highest PDS for P. falciparum targeted HRP2, a number of pLDH-detecting products had high PDS against P. vivax. The thermal stability of tests that target these different antigens also overlapped for samples with high parasite density.

The choice of RDT should take into account the target antigen: HRP2-detecting RDTs should not be used in areas where non-expression of HRP2 is common (11,12). Three P. falciparum RDT products were evaluated in round 6 that detected both P. falciparum pLDH and HRP2; however, detection of P. falciparum pLDH was less sensitive than detection of HRP2 at low parasite density; therefore, low density infections with HRP2-deleted P. falciparum parasites could be missed.

Tests that detect only HRP2 (without pLDH or aldolase lines) will be of limited use where non-falciparum malaria is common. pLDH (and possibly aldolase) RDTs may have further advantages when antigen persistence (common with HRP2) result in a high false-positive rate in areas where early retesting in the weeks immediately after treatment is common. As mentioned in section 2.3, however, combination tests with both HRP2 and pan test lines should not be used for discriminating between acute infection and persistent antigenaemia, as the overall reactivity of pan test lines is much lower than that of HRP2 test lines, particularly at low parasite density.

The required sensitivity of a test may also vary by species: a less sensitive test may be more acceptable for detection of P. vivax than for P. falciparum, as severe outcomes due to missed diagnoses are less likely. Use of a sufficiently sensitive pan-specific-only test may be appropriate in areas where both P. falciparum and P. vivax occur, if all infections are to be managed initially as P. falciparum infections with artemisinin-based combination therapy, but species-specific monitoring data would be lost. Tests with high PDS for both P. falciparum and P. vivax were found in this and previous rounds of product testing (3–7).

Pan-species tests were not evaluated for detection of P. ovale or P. malariae in this evaluation because of lack of sources of suitable mono-species infections with these parasites. Published data suggest that the sensitivity of RDTs for detecting these species is significantly poorer than that for P. falciparum and P. vivax (39).

http://www.who.int/malaria/areas/diagnosis/rapid-diagnostic-tests/malaria_specimen_bank/en/

http://www.who.int/malaria/areas/diagnosis/rapid-diagnostic-tests/malaria_specimen_bank/en/

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16. usIng results to ensure HIgH-QuAlIty dIAgnosIs In tHe fIeld

This report provides data to guide malaria control programmes in selecting products that are likely to perform to a high standard in the context in which the programme operates. Final product selection requires that these data be consid-ered systematically, taking into context the distribution of parasite density in the target population in whom the tests will be used and the experience and training of the intended users. Box 3 lists WHO’s minimum RDT selection criteria, as endorsed by the Malaria Policy Advisory Committee, and Tables S2, S3 and 5 are colour-coded to reflect these minimum performance criteria for product selection. A web-based tool for filtering product testing results by various parameters is available on the FIND website and has now been updated to allow rapid identification of products with the same blood volume, number of buffer drops and time until reading1. Annex 1 also groups products according to similar procedure characteristics. Furthermore, an algorithm to guide selection is given in Annex S3, and detailed guidance was published by WHO in Good practices for selecting and procuring rapid diagnostic tests for malaria (14) and Universal access to malaria diagnostic testing (15).

While malaria RDTs can be used in a number of settings, the greatest impact on public health will ensue from extending access to accurate, parasite-based diagnoses of malaria to regions and populations where good-quality microscopy-based analysis is impractical to maintain. This will allow implementation of WHO recommendations on universal parasite-based diagnosis before antimalarial therapy (2) and currently applies to most people at risk for malaria in endemic countries (1). In many settings where RDTs have been introduced, the true rate of parasitaemia has been found to be considerably lower than expected, so that health systems can reduce wastage of antimalarial medicines and focus on appropriate management of non-malarial causes of fever, including early pneumonia and sepsis. In order for an RDT programme to have its full potential public health impact, it must therefore address not only malaria but also the management of other common and severe febrile illnesses that occur locally in the differential diagnosis of malaria.

1 An interactive guide designed to short-list tests according to programme needs, based on the performance of tests in rounds 3–6 of the WHO product testing programme, can be found at: http://www.finddiagnostics.org/programs/malaria-afs/malaria/current-projects/rdt_quality_control/interactiveguide-intro/interactive-guide/index.jsp (accessed 10 September 2015).

16.1. beyond performance The WHO Prequalification of In Vitro Diagnostics Programme promotes access to good quality in vitro diagnostic tests by applying the principles of a comprehensive regulatory assess-ment. This includes inspection of the manufacturer’s quality management system, including post-market surveillance, assessment of technical documentation (dossier review) and an independent performance evaluation.

The results of the WHO malaria product testing programme fulfil the performance evaluation component of the prequali-fication process. Although, prequalification is not currently a requirement for eligibility for United Nations procurement tenders for malaria RDTs, it is for other RDTs, such as for HIV. At present, 12 malaria RDT products are prequalified2, and the WHO Global Malaria Programme is assessing the impact of requiring WHO prequalification for procurement. Manufacturers are advised that prequalification may be a future requirement in order to be eligible for WHO procure-ment, and are therefore encouraged to apply.

16.2. beyond procurement Diagnostic tests usually represent the start of a health system intervention, and their use is based on the assumption that appropriate patient management, based on testing, will follow. Thus, successful introduction of RDTs requires careful planning beyond rational procurement to ensure consistent supplies of all the necessary materials (including gloves, sharps disposal containers and supplies required for further case management), training of users, community sensitization and monitoring of diagnostic quality and results. This extends malaria management to management of other febrile diseases and health service delivery systems and requires integration with other health programmes.

This report provides information to guide procurement of RDTs within this framework. Factors beyond the perfor-mance characteristics reported here, however, must influence procurement decisions. An example of an algorithm, including an ease-of-use assessment, is provided in Annexes S2 and S3 to guide decisions.

Details of implementation will vary widely between programmes, depending on local capacity and needs. Further recommendations on budgeting, planning and implementation can be found in Annex 5 and in the relevant WHO guidance document (15).

2 http://www.who.int/diagnostics_laboratory/evaluations/151103_prequalified_products_list.pdf?ua=1 (accessed 9 November 2015)

http://www.who.int/diagnostics_laboratory/evaluations/151103_prequalified_products_list.pdf?ua=1

http://www.who.int/diagnostics_laboratory/evaluations/151103_prequalified_products_list.pdf?ua=1


16.3. post-market surveillance: lot verification Post-market surveillance confirms manufacturer compliance with quality expectations and is an important component of any quality assurance scheme. Specifically for malaria RDTs, post-market surveillance ensures that the quality reported in product testing is found in what is available on the market to the user. Post-market surveillance can be performed proactively through lot verification (described next), which is recommended to all procurers, or reactively through comple-tion of a “ WHO user complaint form for reporting problems and/or adverse events related to diagnostic products” and submitted to the following email address: [email protected].

As a complement to product testing, WHO and FIND currently support laboratories that perform continued quality assurance of RDTs in the form of lot testing. This programme responds to requests from all purchasers, including national malaria programmes, manufacturers and procurement bodies, to assess the quality of RDT lots before purchase or, when they arrive in a country, before distribution to the field and for clinical use. Testing is performed against parasite-positive and -negative panels prepared and characterized in the same way as the panels used in this evaluation. A number of national institutions have also developed this capacity. Lot testing reassures countries that the product they have purchased performs to a high standard and helps to ensure that manufacturers produce consistently good lots and

improve their products. The results support decisions for accepting or rejecting lots. Lot testing provides information about the adequacy of RDTs for clinical use, their stability over their shelf life and any anomalies observed during testing that may also be encountered in the field.

Countries and manufacturers ship 100–150 RDTs to regional, WHO-recognized lot testing centres, where they are evaluated against a small panel of parasites at high and low density and against negative samples (Fig. 2). They are subsequently incubated at a temperature close to the manufacturer’s specified storage temperature and retested after 18 months. Initial results are available after 5 days, and definitive results after subsequent retesting. Details of the protocol can be found in the methods manual for lot testing (25). As lot-to-lot variation has previously been noted in many products, purchasers are encouraged to participate in the lot-testing programme to confirm the quality of RDT lots prior to use. Certain anomalies resulting from defects in production lots or RDT degradation may affect the running of the test or interpretation and may warrant a field safety notice and corrective action. In such instances, a special lot testing service can be provided, which is determined case by case.

Lot testing is free of charge, but the requester must cover shipping costs, including related tax and duties. To access lot testing through the WHO-FIND programme, contact [email protected] and [email protected], at least 2 weeks before RDTs are ready for shipment.

17. conclusIons

This report adds to the large data set on malaria RDT perfor-mance published annually since 2009 (3–7). The product testing programme continues to be an authoritative source in the field of malaria RDT evaluations in terms of the number of products evaluated and its comprehensiveness. New labora-tory methods have been developed and validated to support parasite characterization, and this work has generated new findings on variation in antigen content at similar parasite densities and in the structure and expression of histidine-rich

proteins. Publication of the results of past WHO product testing rounds has affected the procurement practices of countries and procurement agencies and contributed to a shift in the malaria RDT market towards better-performing products (1). The report of round 6 adds to the number of well-performing RDTs for which comprehensive performance data are now available and provides updated data on 16 product resubmissions.

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18. references

1. World malaria report 2015. Geneva: World Health Organization; 2015.

2. Guidelines for the treatment of malaria. 2nd edition. Geneva: World Health Organization; 2010.

3. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 1 (2008). Geneva: World Health Organization; 2009.


5. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 3 (2010–11). Geneva: World Health Organization; 2011.



8. Informal consultation on laboratory methods for quality assurance of malaria rapid diagnostic tests. Manila: WHO Regional Office for the Western Pacific; 2004 (RS/2004/GE/26(PHL).

9. Prequalification of in vitro diagnostics. Geneva: World Health Organization (http://www.who.int/diagnos-tics_laboratory/evaluations/en/, accessed 13 October 2015).

10. Parasitological confirmation of malaria diagnosis. Report of a WHO technical consultation. Geneva, 6–8 October 2009. Geneva: World Health Organization; 2010.

11. Gamboa D, Ho MF, Bendezu J, et al. A large proportion of P. falciparum isolates in the Amazon region of Peru lack pfhrp2 and pfhrp3: implications for malaria rapid diagnostic tests. PLoS One 2010:5(1):e8091.

12. Kumar N, Pande V, Bhatt RM, Shah NK, Mishra N, Srivastava B, et al. Genetic deletion of HRP2 and HRP3 in Indian Plasmodium falciparum population and false negative malaria rapid diagnostic test. Acta Trop 2013;125(1):119-121.

13. Malaria RDT interactive guide. Geneva: Foundation for Innovative New Diagnostics (http://www.find-diagnostics.org/programs/malaria-afs/malaria/current-projects/rdt_quality_control/interactiveguide-intro/, accessed 13 October 2015).

14. Good practices for selecting and procuring rapid diagnostic tests for malaria. Geneva: World Health Organization; 2011.

15. Universal access to malaria diagnostic testing: an oper-ational manual. Geneva: World Health Organization; 2011.

16. Kolaczinski J, Mohammed N, Ali, I, et al. Comparison of the OptiMAL rapid antigen test with field micros-copy for the detection of Plasmodium vivax and P. falciparum: considerations for the application of the rapid test in Afghanistan. Ann Trop Med Parasitol 2004;98(1):15–20.

17. Richter J, Gobels K, Muller-Stover I, et al. Co-reactivity of plasmodial histidine-rich protein 2 and aldolase on a combined immuno-chromographic-malaria dipstick (ICT) as a potential semi-quantitative marker of high Plasmodium falciparum parasitaemia. Parasitol Res 2004;94(5): 384–385.

18. Mai Huong NM, Davis TM, Hewitt S, et al. Comparison of three antigen detection methods for diagnosis and therapeutic monitoring of malaria: a field study from southern Vietnam. Trop Med Int Health 2002;7(4):304–308.

19. Mason DP, Kawamoto F, Lin K, et al. A comparison of two rapid field immunochromatographic tests to expert microscopy in the diagnosis of malaria. Acta Trop 2002;82(1):51–59.

20. van den Broek I, Hill O, Gordillo F, et al. Evaluation of three rapid tests for diagnosis of P. falciparum and P. vivax malaria in Colombia. Am J Trop Med Hyg 2006;75(6):1209–1215.

21. McMorrow M, Masanja MI, Kahigwa E, et al. Challenges in routine implementation and quality control of rapid diagnostic tests for malaria – Rufiji District, Tanzania. Am J Trop Med Hyg 2008;79(3):385–390.

22. Wanji S, Kimbi HK, Eyong JE, et al. Performance and usefulness of the Hexagon rapid diagnostic test in children with asymptomatic malaria living in the Mount Cameroon region. Malar J 2008;7:89.

23. Willcox ML, Sanogo F, Graz B, et al. Rapid diagnostic tests for the home-based management of malaria, in a high-transmission area. Ann Trop Med Parasitol 2009;103(1):3–16.

24. Belizario VY, Pasay CJ, Bersabe MJ, et al. Field evaluation of malaria rapid diagnostic tests for the diagnosis of P. falciparum and non-P. falciparum infections. Southeast Asian J Trop Med Public Health 2005;36(3):552–561.

25. Methods manual for laboratory quality control testing of malaria rapid diagnostic tests, version 7. Geneva: World Health Organization; 2014.


26. Methods manual for product testing of malaria rapid diagnostic tests (version 6). Geneva: World Health Organization; 2014.

27. Product testing round 5. Information for manufac-turers and procurers on progress towards product testing of malaria rapid diagnostic tests. Manila: World Health Organization Regional Office for the Western Pacific; 2012 (http://www.wpro.who.int/malaria/sites/rdt/who_rdt_evaluation/call_for_testing_round5.html, accessed 13 October, 2015).

28. Letter from the World Health Organization to manu-facturers. Manila: World Health Organization Regional Office for the Western Pacific; 2012 (http://www.wpro.who.int/sites/rdt/who_rdt_evaluation/call_for_testing_round5.htm; http://www.finddiagnostics.org/, accessed 23 May 2014).

29. Baker J, Ho MF, Pelecanos A, et al. Global sequence variation in the histidine-rich proteins 2 and 3 of Plasmodium falciparum: implications for the perfor-mance of malaria rapid diagnostic tests. Malar J 2010;9:129.

30. Hopkins H, Oyibo W, Luchavez J, et al. Blood transfer devices for malaria rapid diagnostic tests: evalu-ation of accuracy, safety and ease of use. Malar J 2011;10:30.

31. Methods for field trials of malaria rapid diagnostic tests. Manila: World Health Organization Regional Office for the Western Pacific; 2009.

32. Transporting, storing and handling malaria rapid diag-nostic tests at central and peripheral storage facilities. Manila: World Health Organization Regional Office for the Western Pacific; 2009.

33. Training materials for malaria RDTs. Geneva: Foundation for Innovative New Diagnostics; 2011 (http://www.finddiagnostics.org/programs/malaria-afs/malaria/completed-projects/training-materials/, accessed 13 October 2015).

34. Jorgensen P, Chanthap L, Rebueno A, et al., Malaria rapid diagnostic tests in tropical climates: the need for a cool chain. Am J Trop Med Hyg 2006;74(5):750–754.

35. Chiodini PL, Bowers K, Jorgensen P, et al. The heat stability of Plasmodium lactate dehydrogenase-based and histidine-rich protein 2-based malaria rapid diagnostic tests. Trans R Soc Trop Med Hyg 2007;101(4):331–337.

36. Rennie W, Phetsouvanh R, Lupisan S, et al., Minimising human error in malaria rapid diagnosis: clarity of written instructions and health worker performance. Trans R Soc Trop Med Hyg 2007;101(1):9–18.

37. Harvey SA, Jennings L, Chinyama M, et al., Improving community health worker use of malaria rapid diag-nostic tests in Zambia: package instructions, job aid and job aid-plus-training. Malar J 2008;7(1):160.

38. Tavrow P, Knebel E, Cogswell L. Using quality design to improve malaria rapid diagnostic tests in Malawi. In: Operations research results 1(4). Bethesda, Maryland: United States Agency for International Development; 2000.

39. Heutmekers M, Gillet P, Maltha J, et al. Evaluation of the rapid diagnostic test CareStart pLDH Malaria (Pf-pLDH/panpLDH) for the diagnosis of malaria in a reference setting. Malar J 2012;11:204.

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Annex s1: characteristics of evaluation panels used in rounds 1–6 of wHo malaria rdt product testing, 2008–2015Currently, the basis for diagnosing malaria with antigen-detecting RDTs is the detection in a patient’s blood of one or more target malaria antigens, including HRP2 (P. falci-parum only), pLDH (Plasmodium spp.pan-pLDH), P. falciparum (Pf-pLDH), non-falciparum (Pv-pLDH, Pvom-pLDH) and aldolase (all Plasmodium spp). The antigen concentration in samples with the same parasite density varies. Therefore, the concentrations of malaria antigens in the samples that comprise evaluation panels must be consistent in successive rounds of WHO malaria RDT product testing to ensure that the results of each round are highly comparable (statistically equivalent).

Therefore, antigen concentrations were quantified in triplicate in all panel samples, including dilution pairs of 200 and 2000 parasites/µL, by quantitative ELISA. Only results that were consistent in the triplicate runs and showed a value factor between the 200 and the 2000 parasites/µL dilutions close to 10 were considered acceptable and eligible for the performance evaluation panel. In some instances, the antigen concentration was below the detection limit of the ELISA, particularly for aldolase, which is present in malaria parasite samples at much lower concentrations than the other two antigens. Samples that gave inconsistent results for more than one of the three antigens were excluded from the panel.

Despite careful standardization of procedures, the tables and figures below show a wide variation in antigen concentra-tions for the same parasite density. There are a number of possible explanations, including differences in the level of antigen expression by isolates; different durations of infection (accumulating antigens); different parasite growth stages at the time of collection (expressing different levels of antigen); the presence of circulating HRP2 from previous growth cycles; and HRP2 produced by parasites sequestered in the host’s vascular tissues that cannot be accounted for in the estimate of parasite density on the blood slide.

Before each round of WHO malaria RDT product testing, the distribution of HRP2, pLDH and aldolase concentrations at 200 parasites/µL dilution of the wild-type P. falciparum and wild-type P. vivax samples selected for the phase-2 panels were systematically compared with those in the previous round to ensure there was no statistically significant differ-ence. The figures and tables below show the distribution of antigen concentrations in all six performance evaluation panels. No statistically significant differences were seen (Kruskal-Wallis test; p > 0.5), confirming that the results of each new round are additive (and comparable) to the previous ones. In the following box and whisker plots, the end of whiskers represent minimum and maximum values; the box represents middle 50% of data and the line through box represents median values; the crosses represent the mean values.

Figure AS1.1: Box-and-whisker plot of distribution of P. falciparum HRP2 concentration (ng/mL) in product testing phase 2 (wildtype) panels.

10.5 2 4 8 16 32 64 128

P. falciparum HRP2 concentration (ng/ml)

Round 6

Round 5

Round 4

Round 3

Round 2

Round 1

Figure AS1.3: Box-and-whisker plot of distribution of P. vivax pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels.

Round 6

Round 5

Round 4

Round 3

Round 2

Round 1

1 2 4 8 16 32 64

P. vivax pLDH concentration (ng/ml)

Figure AS1.2: Box-and-whisker plot of distribution of P. falciparum pLDH concentration (ng/mL) in product testing phase 2 (wildtype) panels.

Round 6

Round 5

Round 4

Round 3

Round 2

Round 1

0.5

0.25

0.12

5 1 2 4 8 16 32 64

P. falciparum pLDH concentration (ng/ml)

Figure AS1.4: Box-and-whisker plot of distribution of P. falciparum aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels.

0.062

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0.015

625 1 4 16

P. falciparum aldolase concentration (ng/ml)

Round 6

Round 5

Round 4

Round 3

Round 2

Round 1

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Figure AS1.5: Box-and-whisker plot of distribution of P. vivax aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels.

1 2 4 8 16P. vivax aldolase concentration (ng/ml)

Round 6

Round 5

Round 4

Round 3

Round 2

Round 1

Table AS1.1: Statistics for P. falciparum HRP2 concentration (ng/mL) in product testing phase 2 (wild-type) panels.

Round 1 Round 2 Round 3 Round 4 Round 5 Round 6

Number of valuesa 78 99 99 98 99 99

Minimum 0.80 0.62 0.62 0.62 0.59 0.67

25th percentile 2.90 1.90 2.10 2.97 2.15 2.48

Median 9.57 6.76 6.83 6.98 6.76 8.12

75th percentile 18.94 16.91 17.37 15.65 15.31 15.51

Maximum 73.70 73.70 66.70 62.48 62.48 62.48

Mean 15.28 12.70 12.77 12.72 11.65 12.15

Std. Deviation 16.98 15.75 15.19 14.72 13.25 13.29a The number of values is the number of samples for which consistent ELISA results were obtained.

Table AS1.2: Statistics for P. falciparum pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels.



Minimum 0.71 0.19 0.19 0.19 0.19 0.19

25th percentile 6.68 6.27 6.23 6.20 6.90 7.04

Median 11.95 10.31 11.18 10.92 12.24 11.85

75th percentile 23.75 20.10 22.70 21.28 23.05 20.36

Maximum 47.15 47.15 47.15 53.53 43.02 53.53

Mean 15.31 13.71 15.08 14.97 15.53 15.61


Table AS1.3: Statistics for P. vivax pLDH concentration (ng/mL) in product testing phase 2 (wild-type) panels.



Minimum 5.10 1.64 1.64 1.64 1.64 1.64

25th percentile 8.10 8.40 7.30 6.96 6.26 6.72

Median 12.65 17.00 19.78 17.50 13.22 15.17

75th percentile 27.40 29.69 31.89 29.84 23.42 23.14

Maximum 44.40 47.90 47.90 47.90 47.90 44.79

Mean 17.38 20.24 20.99 20.00 16.84 16.90



Table AS1.4: Statistics for P. falciparum aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels.



Minimum 0.00 0.00 0.00 0.00 0.00 0.00

25th percentile 0.84 0.74 0.67 0.64 0.52 0.44

Median 1.58 1.49 1.40 1.25 1.17 1.18

75th percentile 2.25 2.25 2.23 2.25 2.07 2.02

Maximum 9.90 9.90 9.90 9.08 7.74 9.08

Mean 1.93 1.79 1.76 1.72 1.52 1.50


Table AS1.5: Statistics for P. vivax aldolase concentration (ng/mL) in product testing phase 2 (wild-type) panels.



Minimum 3.21 1.70 1.70 1.70 3.21 1.70

25th percentile 4.02 4.11 4.07 4.41 5.55 4.94

Median 6.33 6.15 6.10 6.16 6.86 6.54

75th percentile 8.47 8.47 8.32 9.10 9.43 9.68

Maximum 13.15 13.40 13.30 15.00 15.00 15.08

Mean 6.73 6.81 6.45 6.86 7.78 7.74


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Annex s2: malaria rdt field assessment and anomaliesThe purpose of this assessment, on a limited number of RDTs, is to assess aspects of packaging, safety and ease-of-use and not to evaluate diagnostic accuracy.

Obtain samples of each malaria RDT under consideration (at least one box packaged as intended for delivery to end users).

Obtain malaria parasite-negative blood samples, and where readily accessible, parasite-positive blood samples for testing against RDTs.

Table AS2.1: Field assessment of RDT packaging, safety and ease-of-use to guide product selection

Date of assessment Commercial name Product code Lot number(s)

Yes No NA Problems /CommentsPackaging and accessories

The RDT box is in good conditionRDTs are in individual sealed package

The correctly indicated number of RDTs are in the boxDesiccant is included in each individual RDT package

An expiry date is visible on each RDT packageAll required accessories are included in the correct quantities

(RDT, buffer, blood transfer device, alcohol swab, lancet, gloves, test tubes (for dipsticks, only)

If no, what is not included:

InstructionsInstructions are included

Instructions are in the national language(s)The instructions are for the correct product The instructions include figures displaying

all possible interpretations of the RDT resultsThe text and figures are accurate and consistent

(specifically order of test lines and results interpretation)Preparation and procedure

The test package is easy to openIt is easy to write on the test device

The test lines on the device are clearly labelledIt is easy to use the device for blood collection

It is easy to open the buffer bottle or vialThe buffer bottle or vial have sufficient volume

for testing all RDTs in the boxThe buffer bottle or vial dispenses even drops

It is easy to fill the sample well correctly with the provided blood transfer device

It is easy to fill the buffer well correctly (no overflow)The buffer and sample flow well along the test strip

Result interpretationControl and test lines

Control line is clearTest line(s) are clear

Good clearance of blood by time of reading If no, number of tests in the box affected:

Steps and reading time Reading time <30 min

Two or fewer timed steps Was one or more of the last 10 tests

you performed invalid (no control line)?If YES, how many?

SafetyAre there mixing wells (risk of blood splash)?

Retractable needle for finger prick?Is the RDT in a cassette format (unexposed strip)?

Have waste disposal safety concerns been addressed? (If no, please describe)

NA, not applicable


Figure AS2.1 illustrates examples of RDT observations/anomalies encountered and routinely recorded during round 6 of WHO Malaria RDT Product Testing at the CDC. In most cases, these anomalies do not invalidate the results, as reactivity in the control and test line areas are still visible, but they may pose challenges to health workers interpreting the results. Furthermore, they should be reported to manufacturers.

An expanded list of notable observations concerning RDT packaging, kit accessories (buffer vials, desiccants) and instruc-tions for use, is under development for use in both product testing and lot testing activities of the WHO-FIND Malaria RDT Evaluation Programme.

Figure AS2.1: Malaria RDT anomalies encountered in production lots

a) Observations on the test strip

Red background Background staining is relatively common. In this example, the result is positive as test lines are positive; however, a more intense red background may obscure weak positive test lines, giving false-negative results.

Incomplete clearing In this example, the result is positive as the test line is visible. Poor clearing of blood may obscure weak positive test lines, giving false-negative results.

b) Observations of flow problems

Failed migration Blood and buffer did not run the length of the strip

Incomplete migration One portion of the nitrocellulose near the test band was not absorptive and remained dry during wicking, creating irregular migra-tion of blood/buffer with red background. In this example, the result is positive, as the test line is clearly visible.

c) Observations on test lines

Ghost test lines White lines on a stained background. In this example, the result is negative, as the test line is not dark and is thus not visible.

Patchy broken test line(s)

The test line is visible but interrupted (broken).

Diffuse test line(s) Test line wider than control, without clearly defined edge.

C T1 T2

C T

C T

C T1

C T1 T2 T3

C T1 T2

C T

An

ne

xes


d) RDT structural problems

Strip misplaced in the cassette (shift)

Strip can be seen only partially in the results window.

Specimen pad not seen in sample window

Normally, the colour of the conjugated antibody can be seen in the sample window (commonly purple, pink or blue).

Buffer remains pooled in the buffer well

The buffer is not completely absorbed and this may result in failed migration or incomplete clearing.

C T1 T2


Figure AS3.1: How to select of an appropriate RDT

Step 1.1Define setting of use

What? target parasite species and antigena

Pf-only or mixed Pf/non-Pf infections:- HRP2- pLDH-Pf; pLDH-pan

Pf and non-Pf infections (single species)b:- HRP2, aldolase; HRP2, pLDH-pan- HRP2, pLDH-Pv; HRP2, pLDH-Pvom- HRP2, pLDH-pan; pLDH-Pv- pLDH-Pf, pLDH-pan; pLDH-Pf, pLDH-Pv- pLDH-Pf, pLDH-Pvom

P. vivax, only:- aldolase- pLDH-pan- pLDH-Pv

**Pf without HRP2 – Do not use HRP2-based RDTsc

Where? Exposure to high temperature e.g. tropical environment ORtemperature-controlled environment, including during transport and storage

Who? Laboratory personnel ORhealth workers outside laboratories

Step 1.2Review RDT performance

WHO RDT product testing resultsd and apply WHO recommended RDT selection criteriae

- Panel detection score - False-positivity rate - Invalid rate - Ease-of-use- Thermal stability

Sensitivity and specificity based on high-quality field studies in relevant populations

Generate short-list of RDTs

Step 1.3Apply national guidelines and experience in use of RDTs

National malaria treatment guidelines

In-country experience, ease-of-use assessments (Annex S2), availability of training materials

Step 1.4Other considerations

- Price- Manufacturer: production capacity, lead times, heat stability data and storage conditions- Delivery schedules (e.g. staggered deliveries), box size, shelf life- Registration requirements of national regulatory authorities- Product lot testing results- Overall budget requirements (Annex 5)

a Pf-only or mixed Pf/non-Pf infections: Most areas of sub-Saharan Africa and lowland Papua New Guinea; Pf and non-Pf infections (single species): Most endemic areas of Asia and the Americas and isolated areas of the Horn of Africa; Mainly P. vivax-only: areas of East Asia, central Asia, South America, and some highland areas elsewhere

b Tests with a P. falciparum-specific line and pan-specific line will not distinguish P. falciparum-only infections from mixed P. falciparum infections. Distinguishing P. falciparum from mixed P. falciparum-vivax infections is important only if a full course of primaquine is routinely given for infections due to P. vivax. This must be weighed against the loss of ability to detect P. malariae and P. ovale if a test has only P. falciparum- and P. vivax-specific lines. Inclusion of further test lines (e.g. Pf-Pv-pan-pLDH) to detect these increases the complexity of test interpretation. A programme should prioritize these various advantages and disadvantages according to local conditions in the initial stage of making procurement decisions.

c P. falciparum parasites lacking HRP2 +/- HRP3 genes have been identified with high frequency in parts of South America (1). d See references (2–6).e WHO RDT procurement criteria : http://www.who.int/malaria/publications/atoz/rdt_selection_criteria/en/ (accessed 29 september 2015).

For a comprehensive guide to procurement of malaria RDTs extending beyond selection to quantification, budgeting, technical specifications, management of tenders, contracts, supply management and monitoring of supplier performance and managing product variations, see reference (7).

Annex s3: selection of an appropriate rdt

http://www.who.int/malaria/publications/atoz/rdt_selection_criteria/en

An

ne

xes


Anne

x 1:

cha

ract

eris

tics

of r

dts

eva

luat

ed in

rou

nd 6

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asm

odiu

m

spec

ies

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eted

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= P

. fal

cipa

rum

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= P.

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ax

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vale

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= P

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aria

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n; m

ajor

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asm

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spec

ies)

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Max

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Prot

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grou

ps b

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on

thei

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oced

ural

ch

arac

teris

tics,

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lly, b

lood

vol

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(µL)

, num

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f buf

fer d

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The

grou

ps a

re a

s fo

llow

s: g

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dro

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0 m

ins;

gr

oup

2: 5

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dro

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0 m

ins;

gro

up 3

: 5µL

, 4 d

rops

, 20

min

s; g

roup

4:

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2 dr

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30 m

ins;

gro

up 5

: 5µL

, 4 d

rops

, 30

min

s; g

roup

6:

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3 dr

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15 m

ins;

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L, 4

drop

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8: 1

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f Se

e An

nex

2

g Fo

rmat

s in

clud

e: c

asse

tte

(A);

card

(B);

hybr

id (C

), di

pstic

k (D

); or

oth

er (E

). Ea

ch

prod

uct

shou

ld id

eally

be

acco

mpa

nied

by

all r

equi

red

mat

eria

ls (l

ance

t, pi

pett

e,

etc.

) par

ticul

arly

whe

n us

ed a

t the

vill

age

heal

th w

orke

r lev

el; h

owev

er, t

his i

s oft

en

not t

he c

ase

and

the

cont

ents

dep

end

on th

e re

ques

t of t

he p

rocu

ring

agen

t.

A Ca

sset

teB

Card

C Ca

sset

te h

ybrid

D

Dips

tick

E O

ther

CT

SA

CT

S

C T1 T2C

PP

f

Sam

ple

and

m

ixin

g w

ells

T1CT2

Ann

ex 1

: Cha

ract

eris

tics

of R

DTs

eval

uate

d in

rou

nd 6

(con

tinue

d)

An

ne

xes


Annex 2: malaria rdts: guide to interpretation of results

type A: guide to results of generic pf malaria rdtsResults window: C=control line; T=test line with bound HRP2 or Pf-specific pLDH antibody.

C T

Negative results: One line ‘C’ appears in the results window.

C T

Positive results: P. falciparum infection. Two lines ‘C’ and ‘T’ appear in the results window. Test is positive even if the test line is faint.

C T

Invalid results: No ‘C’ line appears in the results window. Repeat the test with a new RDT if no control line appears.

C T

C T


type b: guide to results of generic major Plasmodium species (pan) malaria rdts Results window: C=control line; T=test line with bound pan-specific pLDH or aldolase antibody.

C T

Negative results: One line ‘C’ appears in the results window.

C T

Positive results: Plasmodium species (P. falciparum, P. vivax, P. malariae, P. ovale) infection. Two lines ‘C’ and ‘T’ appear in the results window. Test is positive even is the test line is faint.

C T


C T

C T

An

ne

xes


type c: guide to results of generic pan-pf malaria rdtsResults window: C=control line; T1=test line with bound pLDH or aldolase antibody; T2=test line with bound HRP2

and/or Pf-specific pLDH antibody.

C T2T1

Negative results: Only one line ‘C’ appears in the results window.

C T1 T2

Positive results:

P. falciparum: Two lines ‘C’ and ‘T2” appear in the results window.

C T1 T2

Non-falciparum infection (P. vivax, P. ovale, P. malariae) or mixed infection: Two lines ‘C’ and ‘T1” appear in the results window.

C T1 T2

P. falciparum or mixed infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.

C T1 T2


C T1 T2

C T1 T2

C T1 T2

C T1 T2


type d: guide to results of generic pf-pan malaria rdtsResults window: C=control line; T1=test line with bound HRP2 or Pf-specific LDH antibody;

T2=test line with bound pLDH or aldolase antibody.

C T2T1


C T1 T2

Positive results:

P. falciparum infection. Two lines ‘C’ and ‘T1’ appear in the results window.

C T1 T2

Non-falciparum infection (P. vivax, P. ovale, P. malariae) or mixed infection. Two lines ‘C’ and ‘T2’ appear in the results window.

C T1 T2

P. falciparum or mixed infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.

C T1 T2


C T1 T2

C T1 T2

C T1 T2

C T1 T2

An

ne

xes


type e: guide to results of generic pv-pf malaria rdtsResults window: C=control line; T1=test line with bound P. vivax-specific pLDH;

T2=test line with bound HRP2 or Pf-specific pLDH antibody.

C T2T1


C T1 T2

Positive results:


C T1 T2

P. vivax infection. Two lines ‘C’ and ‘T1’ appear in the results window.

C T1 T2

P. falciparum and P. vivax mixed infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.

C T1 T2


C T1 T2

C T1 T2

C T1 T2

C T1 T2


type f: guide to results of generic pf-pv malaria rdtsResults window: C=control line; T1= test line with bound HRP2 or Pf-specific pLDH antibody;

T2=test line with bound P. vivax-specific pLDH.

C T2T1


C T1 T2

Positive results:


C T1 T2


C T1 T2


C T1 T2


C T1 T2

C T1 T2

C T1 T2

C T1 T2

An

ne

xes


type g: guide to results of generic pan-pv-pf malaria rdtsResults window: C=control line; T1=test line with bound pLDH or aldolase antibody; T2=test line with bound P. vivax-specific

pLDH; T3=test line with bound HRP2 or Pf-specific pLDH antibody

C T2 T3T1


C T1 T2 T3

Positive results:


C T1 T2 T3


C T1 T2 T3

P. falciparum with or without mixed infection with P. ovale or P. malariae. Three lines ‘C’, ‘T1’ and ‘T3’ appear in the results window.

C T1 T2 T3


C T1 T2 T3

P. falciparum and P. vivax mixed infection with or without P. ovale and/or P. malariae infection. Four lines ‘C’, ‘T1’, ‘T2’ and ‘T3’ appear in the results window.

C T1 T2 T3


P. vivax with or without P. ovale and/or P. malariae infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results

window.

C T1 T2 T3

P. malariae with or without P. ovale and/or P. vivax infection. Two lines ‘C’ and ‘T1’ appear in the results window.

C T1 T2 T3


C T1 T2 T3

C T1 T2 T3

C T1 T2 T3

C T1 T2 T3

C T1 T2 T3

C T1 T2 T3

C T1 T2 T3

C T1 T2 T3

An

ne

xes


type H: guide to results of generic vom1-pf malaria rdtsResults window: C=control line; T1= test line with bound pLDH specific for non-P. falciparum (P. vivax, P. ovale and P. malariae);

T2=test line with bound HRP2 or Pf-specific pLDH antibody

C T2T1


C T1 T2

Positive results:


C T1 T2

P. falciparum mixed infection (with P. vivax, P. ovale and/or P. malariae). Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.

C T1 T2

Non-P. falciparum infection (P. vivax, P. ovale and P. malariae) or mixed infection. Two lines ‘C’ and ‘T1’ appear in the results window.

C T1 T2


C T1 T2

C T1 T2

C T1 T2

C T1 T2

1 vom, P. vivax, P. ovale, P. malariae


type I: guide to results of generic pv malaria rdts Results window: C=control line; T=test line with bound P. vivax-specific pLDH.

C T


C T

Positive results: P. vivax infection. Two lines ‘C’ and ‘T’ appear in the results window.

C T


C T

C T

An

ne

xes


type j: guide to results of generic pf-pf malaria rdtsResults window: C=control line; T1= test line with bound pLDH specific for P. falciparum;

T2=test line with bound HRP2.

C T2T1


C T1 T2

Positive results:


C T1 T2


C T1 T2

P. falciparum infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.

C T1 T2


C T1 T2

C T1 T2

C T1 T2

C T1 T2


type k: guide to results of generic pv-pf-pf malaria rdtsResults window: C=control line; T1= test line with bound P. vivax-specific pLDH; T2=test line with bound HRP2 or Pf-specific

pLDH antibody; T3=test line with bound HRP2 or Pf-specific pLDH antibody. If an RDT has bound HRP2 antibodies on T2, T3 will have bound Pf-specific pLDH and vice versa (T2 Pf antigen target ≠ T3 Pf antigen target).

C T2 T3T1


C T1 T2 T3

Positive results:


C T1 T2 T3


C T1 T2 T3


C T1 T2 T3

P. falciparum infection and P. vivax mixed infection. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.

C T1 T2 T3

P. falciparum infection and P. vivax mixed infection. Three lines ‘C’, ‘T1’ and ‘T3’ appear in the results window.

C T1 T2 T3

An

ne

xes


P. falciparum infection and P. vivax mixed infection. Four lines ‘C’, ‘T1’, ‘T2’ and ‘T3’ appear in the results window.

C T1 T2 T3


C T1 T2 T3


C T1 T2 T3

C T1 T2 T3

C T1 T2 T3

C T1 T2 T3

C T1 T2 T3

C T1 T2 T3

C T1 T2 T3

C T1 T2 T3


type l: guide to results of generic pan-pf-pf malaria rdtsResults window: C=control line; T1= test line with bound PAN-pLDH or aldolase antibody; T2=test line with bound HRP2 or

Pf-specific pLDH antibody; T3=test line with bound HRP2 or Pf-specific pLDH antibody. If an RDT has bound HRP2 antibodies on T2, T3 will have bound Pf-specific pLDH and vice versa (T2 Pf antigen target ≠ T3 Pf antigen target)

C T2 T3T1


C T1 T2 T3

Positive results:


C T1 T2 T3


C T1 T2 T3


C T1 T2 T3

P. falciparum infection with or without mixed infection with P. vivax, P. ovale and/or P. malariae. Three lines ‘C’, ‘T1’ and ‘T2’ appear in the results window.

C T1 T2 T3

P. falciparum infection with or without mixed infection with P. vivax, P. ovale and/or P. malariae. Three lines ‘C’, ‘T1’ and ‘T3’ appear in the results window.

C T1 T2 T3

An

ne

xes


P. falciparum infection with or without mixed infection with P. vivax, P. ovale and/or P. malariae. Four lines ‘C’, ‘T1’, ‘T2’ and ‘T3’ appear in the results window.

C T1 T2 T3

Non-P. falciparum infection (P. vivax, P. ovale, P. malariae) or mixed infection. Two lines ‘C’ and ‘T1’ appear in the results window.

C T1 T2 T3


C T1 T2 T3

C T1 T2 T3

C T1 T2 T3

C T1 T2 T3

C T1 T2 T3

C T1 T2 T3

C T1 T2 T3

C T1 T2 T3


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rdin

g to

man

ufac

ture

r’s in

stru

ctio

ns.

b N

umbe

r of s

ampl

es th

at re

turn

ed a

pos

itive

resu

lt fo

r bot

h te

sts.

Whe

re o

ne te

st w

as in

valid

and

the

othe

r pos

itive

, pos

itive

agr

eem

ent w

as re

cord

ed.

Tabl

e A

3.1

(con

tinue

d)


Tabl

e A

3.2:

Dis

trib

utio

n of

tes

t ba

nd in

tens

ity

(0-4

) sc

ores

aga

inst

pha

se-1

P. f

alci

paru

m c

ultu

red

para

site

s at

low

(200

) an

d hi

gh (2

000)

par

asit

e de

nsit

y (p

aras

ites

/μL)

Prod

uct

Prod

uct

code

Man

ufac

ture

r

200

para

sites

/µL

2000

par

asite

s/µL

200

para

sites

/µL

2000

par

asite

s/µL

Perc

enta

ge d

istrib

utio

n of

Pf

te

st b

and

inte

nsity

b (n

=80)

Perc

enta

ge d

istrib

utio

n of

Pf

te

st b

and

inte

nsity

b (n

=40)

Perc

enta

ge d

istrib

utio

n of

pan

te

st b

and

inte

nsity

b (n

=80)

Perc

enta

ge d

istrib

utio

n of

pan

te

st b

and

inte

nsity

b (n

=40)

0a1

23

40a

12

34

0a1

23

40a

12

34

Pf o

nly

BION

OTE

MAL

ARIA

P.f.

Ag

Rapi

d Te

st K

itRG

19-1

1Bi

oNot

e, In

c.0.

08.

863

.825

.02.

50.

00.

02.

530

.067

.5N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Care

Star

t™ M

alar

ia H

RP2/

pLDH

(Pf)

G018

1/G0

181-

ETAc

cess

Bio

, Inc

.0.

06.

347

.531

.315

.00.

00.

00.

05.

095

.0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

EzDx

™ M

alar

ia P

f Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

08Ad

vy C

hem

ical

Priv

ate

Lim

ited

15.0

61.3

22.5

1.3

0.0

0.0

5.0

35.0

40.0

20.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Firs

t Res

pons

e® M

alar

ia A

ntig

en P

. fal

cipa

rum

(HRP

2)

Card

Tes

tPI

13FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

0.0

15.0

51.3

22.5

11.3

0.0

0.0

0.0

10.0

90.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Hum

asis

Mal

aria

P.f

Antig

en T

est

ANM

PF-7

025

Hum

asis

Co.

, Ltd

.0.

038

.842

.517

.51.

30.

00.

05.

032

.562

.5N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Mal

aria

Ant

igen

Tes

t-Pf

MAG

0104

0Os

car M

edic

are

Pvt.

Ltd.

0.0

3.8

52.5

31.3

12.5

0.0

0.0

0.0

5.0

95.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

One

Step

Mal

aria

P.f

Who

le b

lood

Tes

tW

37-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.5.

028

.852

.513

.80.

00.

00.

05.

040

.055

.0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

OnSi

te M

alar

ia P

f Ag

Rapi

d Te

stR0

114C

CTK

Biot

ech,

Inc.

3.8

31.3

40.0

25.0

0.0

0.0

0.0

2.5

40.0

57.5

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Rapi

d 1-

2-3®

Hem

a® C

asse

tte

Mal

aria

PF

MAL

-PF-

CAS/

25 (1

00)

Hem

a Di

agno

stic

Sys

tem

s0.

016

.358

.820

.05.

00.

00.

00.

010

.090

.0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

(HRP

II)C1

0RH

A25

Rapi

GEN

Inc.

1.3

3.8

25.0

50.0

20.0

2.5

0.0

0.0

10.0

87.5

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Righ

tSig

n® M

alar

ia P.

f. Ra

pid

Test

Cas

sette

(Who

le B

lood

)IM

PF-C

51H

angz

hou

Biot

est B

iote

ch C

o., L

td.

1.3

55.0

36.3

7.5

0.0

0.0

2.5

22.5

40.0

35.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

SD B

iolin

e M

alar

ia A

g P.

f (H

RP2/

pLDH

) - H

RP2

band

05FK

90St

anda

rd D

iagn

ostic

s, In

c.0.

05.

037

.545

.012

.50.

00.

00.

07.

592

.5N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

SD B

iolin

e M

alar

ia A

g P.f

(HRP

2/pL

DH) -

Pf-

pLDH

ban

d05

FK90

Stan

dard

Dia

gnos

tics,

Inc.

17.5

82.5

0.0

0.0

0.0

0.0

0.0

82.5

17.5

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Pf a

nd p

anAT

OMOR

APID

™ M

ALAR

IA (P

F/PA

N)

MM

AL01

Atom

o Di

agno

stic

s PT

Y Li

mite

d0.

018

.860

.020

.01.

30.

00.

05.

045

.050

.010

0.0

0.0

0.0

0.0

0.0

12.5

85.0

2.5

0.0

0.0

BION

OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kit

RG19

-08

BioN

ote,

Inc.

0.0

16.3

68.8

15.0

0.0

0.0

0.0

5.0

50.0

45.0

92.5

7.5

0.0

0.0

0.0

0.0

42.5

57.5

0.0

0.0

BioT

race

r™ M

alar

ia P

.f/PA

N R

apid

Car

d17

012

Bio

Focu

s Co

., Lt

d.2.

53.

851

.340

.02.

50.

00.

02.

522

.575

.028

.871

.30.

00.

00.

00.

00.

082

.517

.50.

0

EzDx

™ M

alar

ia P

an/P

f Rap

id te

st d

etec

tion

Kit

RK M

AL 0

01Ad

vy C

hem

ical

Priv

ate

Lim

ited

1.3

47.5

40.0

11.3

0.0

0.0

0.0

15.0

37.5

47.5

80.0

20.0

0.0

0.0

0.0

0.0

60.0

40.0

0.0

0.0

First

Res

pons

e® M

alar

ia A

g. p

LDH/

HRP2

Com

bo C

ard

Test

PI16

FRC

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.0.

027

.545

.020

.07.

50.

00.

02.

512

.585

.023

.876

.30.

00.

00.

00.

017

.582

.50.

00.

0

Hum

asis

Mal

aria

P.f/

Pan

Antig

en T

est

ANM

AL-7

025

Hum

asis

Co.

, Ltd

.0.

033

.843

.816

.36.

30.

00.

00.

027

.572

.597

.52.

50.

00.

00.

012

.585

.02.

50.

00.

0

Is It

… M

alar

ia P

f/Pv

Dev

ice

AL03

0M

edso

urce

Ozo

ne B

iom

edic

als

1.3

7.5

45.0

31.3

15.0

0.0

0.0

0.0

12.5

87.5

58.8

41.3

0.0

0.0

0.0

0.0

25.0

72.5

2.5

0.0

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.1.

342

.541

.313

.81.

30.

00.

05.

020

.075

.036

.362

.51.

30.

00.

00.

015

.075

.010

.00.

0

One

Step

Mal

aria

P.f/

Pan

Who

le B

lood

Tes

tW

62-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.1.

350

.040

.08.

80.

00.

00.

017

.527

.555

.010

0.0

0.0

0.0

0.0

0.0

55.0

42.5

2.5

0.0

0.0

OnSi

te M

alar

ia P

f/Pa

n Ag

Rap

id T

est

R011

3CCT

K Bi

otec

h, In

c.0.

036

.343

.818

.81.

30.

00.

07.

542

.550

.086

.313

.80.

00.

00.

00.

062

.537

.50.

00.

0

Para

scre

en®

- Ra

pid

Test

for M

alar

ia P

an/P

f50

3030

025

Zeph

yr B

iom

edic

als

0.0

22.5

51.3

22.5

3.8

0.0

0.0

0.0

25.0

75.0

50.0

50.0

0.0

0.0

0.0

0.0

2.5

90.0

7.5

0.0

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

Dia

gnos

tics,

Inc.

0.0

51.3

41.3

7.5

0.0

0.0

0.0

12.5

47.5

40.0

27.5

72.5

0.0

0.0

0.0

0.0

57.5

42.5

0.0

0.0

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pan

(HRP

II/pL

DH)

C30R

HA2

5Ra

piG

EN In

c.0.

00.

042

.538

.818

.80.

00.

00.

020

.080

.085

.015

.00.

00.

00.

00.

072

.527

.50.

00.

0

Pf a

nd P

vAd

vanc

ed Q

ualit

y™ O

ne S

tep

Mal

aria

(Pf/

Pv) T

ri-lin

e Te

st (w

hole

blo

od)

ITP1

1003

TC4

0In

Tec

Prod

ucts

, Inc

.2.

548

.836

.311

.31.

30.

00.

07.

537

.555

.0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

BioT

race

r™ M

alar

ia P

.f/P.

v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

0.0

0.0

30.0

45.0

25.0

0.0

0.0

0.0

15.0

85.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Core

test

s® O

ne S

tep

Mal

aria

Pf/

Pv A

g Te

st D

evic

eB4

2-21

/B42

-22

Core

Tec

hnol

ogy

Co.,

Ltd.

1.3

47.5

40.0

11.3

0.0

2.5

0.0

15.0

45.0

37.5

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

EzDx

™ M

alar

ia P

v/Pf

Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

03Ad

vy C

hem

ical

Priv

ate

Lim

ited

3.8

52.5

35.0

7.5

1.3

0.0

5.0

12.5

30.0

52.5

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Falc

iVax

™ -

Rap

id T

est f

or M

alar

ia P

v/Pf

5030

1002

5Ze

phyr

Bio

med

ical

s0.

022

.550

.017

.510

.00.

00.

00.

015

.085

.0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Firs

t Res

pons

e® M

alar

ia A

g Pf

/Pv

Card

Tes

tPI

19FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

1.3

26.3

42.5

18.8

11.3

0.0

0.0

0.0

15.0

85.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Hum

asis

Mal

aria

P.f/

P.v

Antig

en T

est

ANM

IV-7

025

Hum

asis

Co.

, Ltd

.1.

333

.845

.015

.05.

00.

00.

05.

022

.572

.5N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

An

ne

xes


Prod

uct

Prod

uct

code

Man

ufac

ture

r

200

para

sites

/µL

2000

par

asite

s/µL

200

para

sites

/µL

2000

par

asite

s/µL

Perc

enta

ge d

istrib

utio

n of

Pf

te

st b

and

inte

nsity

b (n

=80)

Perc

enta

ge d

istrib

utio

n of

Pf

te

st b

and

inte

nsity

b (n

=40)

Perc

enta

ge d

istrib

utio

n of

pan

te

st b

and

inte

nsity

b (n

=80)

Perc

enta

ge d

istrib

utio

n of

pan

te

st b

and

inte

nsity

b (n

=40)

0a1

23

40a

12

34

0a1

23

40a

12

34

KHB®

Mal

aria

Ag

P.f/

P.v

Rapi

d Te

stKH

-R-0

7-50

Shan

ghai

Keh

ua B

io-e

ngin

eerin

g Co

., Ltd

.0.

013

.850

.026

.310

.00.

00.

02.

520

.077

.5N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Mal

aria

PV/

PF (p

LDH

/HRP

2) A

ntig

en T

est

Inf-

72N

anto

ng E

gens

Bio

tech

nolo

gy C

o., L

td.

2.5

5.0

61.3

26.3

5.0

0.0

0.0

0.0

20.0

80.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Mer

iscr

een

Mal

aria

Pf/

Pv A

gM

FLRP

D-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.1.

340

.043

.812

.52.

50.

00.

02.

535

.062

.5N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

One

Step

Mal

aria

P.f/

P.v

Who

le B

lood

Tes

tW

056-

CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

3.8

45.0

43.8

7.5

0.0

0.0

0.0

17.5

35.0

47.5

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

d Te

stR0

112C

CTK

Biot

ech,

Inc.

1.3

43.8

42.5

12.5

0.0

0.0

0.0

10.0

55.0

35.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Quic

kPro

file™

Mal

aria

Pf/

Pv T

est

7105

0Lu

miq

uick

Dia

gnos

tics,

Inc.

1.3

33.8

50.0

13.8

1.3

0.0

0.0

7.5

37.5

55.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pv

(HRP

II/pL

DH)

C40R

HA2

5Ra

piG

EN In

c.0.

01.

336

.346

.316

.30.

00.

00.

012

.587

.5N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

SD B

iolin

e M

alar

ia A

g P.

f/P.

v05

FK80

Stan

dard

Dia

gnos

tics,

Inc.

0.0

2.5

50.0

41.3

6.3

0.0

0.0

0.0

22.5

77.5

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Pf a

nd P

f an

d Pv

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v -

HRP

2 ba

nd05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.0.

03.

840

.035

.021

.30.

00.

00.

010

.090

.0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v -

Pf-p

LDH

ban

d05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.36

.363

.80.

00.

00.

00.

00.

067

.532

.50.

0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

NA,

not

app

licab

lePf

, Pla

smod

ium

falc

ipar

um

Pv,

Plas

mod

ium

viv

ax

pan

, Pla

smod

ium

spec

ies

a

Deno

tes

no b

and

visi

ble

b Ca

lcul

atio

ns in

clud

e in

valid

test

s

Tabl

e A

3.2

(con

tinue

d)


Anne

x 4:

pha

se-2

res

ults

Tabl

e A

4.1:

Lot

var

iatio

n in

pos

itive

res

ults

aga

inst

pha

se-2

wild

-typ

e P.

fal

cipa

rum

and

P. v

ivax

sam

ples

at

low

(200

) an

d hi

gh (2

000)

par

asit

e de

nsit

y (p

aras

ites

/μL)

Prod

uct

Prod

uct

code

Man

ufac

ture

r

P. f

alci

paru

m s

ampl

es (n

=100

)P.

viv

ax s

ampl

es (n

=35)

Tota

l pos

itive

res

ults

a re

turn

edTo

tal p

ositi

ve r

esul

tsa

retu

rned

200

para

sites

/µL

2000

b

para

sites

/μL

200

para

sites

/µL

2000

b

para

sites

/μL

Lot

1Lo

t 2

Lot

1Lo

t 2

Lot

1Lo

t 2

Lot

1Lo

t 2

Test

1Te

st 2

No.

pos

itive

ag

reem

ents

c (m

ax=1

00)

Test

1Te

st 2

No.

pos

itive

ag

reem

ents

c (m

ax=1

00)

Test

1Te

st 2

Test

1Te

st 2

No.

pos

itive

ag

reem

ents

c (m

ax=3

5)Te

st 1

Test

2N

o. p

ositi

ve

agre

emen

tsc

(max

=35)

Test

1Te

st 2

Pf o

nly

BION

OTE

MAL

ARIA

P.f.

Ag

Rapi

d Te

st K

itRG

19-1

1Bi

oNot

e, In

c.93

.094

.091

.092

.093

.090

.010

0.0

100.

0N

AN

AN

AN

AN

AN

AN

AN

A

Care

Star

t™ M

alar

ia H

RP2/

pLDH

(Pf)

G018

1/G0

181-

ETAc

cess

Bio

, Inc

.94

.095

.092

.097

.097

.096

.010

0.0

99.0

NA

NA

NA

NA

NA

NA

NA

NA

EzDx

™ M

alar

ia P

f Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

08Ad

vy C

hem

ical

Priv

ate

Lim

ited

79.0

77.0

75.0

78.0

78.0

74.0

100.

099

.0 (9

9)N

AN

AN

AN

AN

AN

AN

AN

A

Firs

t Re

spon

se®

Mal

aria

Ant

igen

P. f

alci

paru

m

(HRP

2) C

ard

Test

PI13

FRC

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.96

.095

.093

.094

.096

.093

.010

0.0

100.

0N

AN

AN

AN

AN

AN

AN

AN

A

Hum

asis

Mal

aria

P.f

Antig

en T

est

ANM

PF-7

025

Hum

asis

Co.

, Ltd

.93

.091

.089

.096

.095

.093

.010

0.0

100.

0N

AN

AN

AN

AN

AN

AN

AN

A

Mal

aria

Ant

igen

Tes

t-Pf

MAG

0104

0Os

car M

edic

are

Pvt.

Ltd.

96.0

97.0

94.0

98.0

96.0

95.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

NA

NA

One

Step

Mal

aria

P.f

Who

le b

lood

Tes

tW

37-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.92

.092

.091

.091

.093

.088

.010

0.0

99.0

NA

NA

NA

NA

NA

NA

NA

NA

OnSi

te M

alar

ia P

f Ag

Rapi

d Te

stR0

114C

CTK

Biot

ech,

Inc.

83.0

(99)

79.0

78.0

(99)

81.0

(98)

78.0

(99)

73.0

(97)

100.

099

.0N

AN

AN

AN

AN

AN

AN

AN

A

Rapi

d 1-

2-3®

Hem

a® C

asse

tte

Mal

aria

PF

MA

L-

PF

-CA

S/25

(100

)H

ema

Diag

nost

ic S

yste

ms

96.0

95.0

94.0

98.0

95.0

(99)

95.0

(99)

100.

010

0.0

NA

NA

NA

NA

NA

NA

NA

NA

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

(HRP

II)C1

0RH

A25

Rapi

GEN

Inc.

95.0

93.0

93.0

89.0

92.0

(99)

89.0

(99)

98.0

(99)

100.

0N

AN

AN

AN

AN

AN

AN

AN

A

Righ

tSig

n® M

alar

ia P

.f. R

apid

Tes

t Ca

sset

te

(Who

le B

lood

)IM

PF-C

51H

angz

hou

Biot

est

Biot

ech

Co.,

Ltd.

86.0

88.0

82.0

87.0

86.0

82.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

NA

NA

SD B

iolin

e M

alar

ia A

g P.

f (H

RP2/

pLDH

)05

FK90

Stan

dard

Dia

gnos

tics,

Inc.

94.0

95.0

93.0

90.0

94.0

88.0

100.

010

0.0

NA

NA

NA

NA

NA

NA

NA

NA

Pf a

nd p

an

ATOM

ORAP

ID™

MAL

ARIA

(PF/

PAN

)M

MAL

01At

omo

Diag

nost

ics

PTY

Lim

ited

95.0

93.0

92.0

93.0

(99)

96.0

93.0

(99)

100.

010

0.0

17.0

18.0

12.0

20.0

15.0

14.0

35.0

34.0

BION

OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kit

RG19

-08

BioN

ote,

Inc.

89.0

91.0

88.0

86.0

86.0

84.0

100.

010

0.0

29.0

30.0

27.0

26.0

28.0

25.0

35.0

35.0

BioT

race

r™ M

alar

ia P

.f/PA

N R

apid

Car

d17

012

Bio

Focu

s Co

., Lt

d.94

.090

.089

.092

.092

.088

.010

0.0

100.

035

.035

.035

.035

.035

.035

.035

.035

.0

EzDx

™ M

alar

ia P

an/P

f Rap

id te

st d

etec

tion

Kit

RK M

AL 0

01Ad

vy C

hem

ical

Priv

ate

Lim

ited

88.0

86.0

84.0

83.0

82.0

80.0

100.

010

0.0

34.0

33.0

32.0

34.0

35.0

34.0

35.0

35.0

Firs

t Res

pons

e® M

alar

ia A

g. p

LDH

/HRP

2 Co

mbo

Car

d Te

stPI

16FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

92.0

91.0

87.0

92.0

92.0

89.0

100.

010

0.0

35.0

34.0

34.0

35.0

33.0

33.0

35.0

35.0

Hum

asis

Mal

aria

P.f/

P an

Antig

en T

est

ANM

AL-7

025

Hum

asis

Co.

, Ltd

.91

.095

.090

.093

.093

.092

.099

.010

0.0

26.0

30.0

25.0

30.0

(34)

31.0

27.0

(34)

35.0

34.0

Is It

… M

alar

ia P

f/Pv

Dev

ice

AL03

0M

edso

urce

Ozo

ne B

iom

edic

als

93.0

(99)

92.0

(97)

87.0

(96)

97.0

95.0

(99)

94.0

(99)

99.0

100.

034

.035

.034

.034

.034

.033

.034

.0 (3

4)34

.0 (3

4)

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.86

.080

.079

.088

.087

.083

.010

0.0

100.

028

.028

.026

.031

.031

.030

.035

.035

.0

One

Step

Mal

aria

P.f/

Pan

Who

le B

lood

Tes

tW

62-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.88

.084

.081

.085

.086

.083

.010

0.0

100.

011

.013

.08.

019

.011

.09.

035

.035

.0

OnSi

te M

alar

ia P

f/Pa

n Ag

Rap

id T

est

R011

3CCT

K Bi

otec

h, In

c.85

.0 (9

9)82

.079

.0 (9

9)83

.083

.0 (9

9)80

.0 (9

9)10

0.0

99.0

35.0

32.0

32.0

35.0

33.0

33.0

35.0

34.0

Para

scre

en®

- Ra

pid

Test

for M

alar

ia P

an/P

f50

3030

025

Zeph

yr B

iom

edic

als

89.0

87.0

85.0

86.0

85.0

81.0

100.

010

0.0

34.0

35.0

34.0

35.0

35.0

35.0

35.0

35.0

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

Dia

gnos

tics,

Inc.

86.0

84.0

83.0

85.0

85.0

83.0

99.0

99.0

(99)

34.0

35.0

34.0

33.0

35.0

33.0

35.0

35.0

An

ne

xes


Prod

uct

Prod

uct

code

Man

ufac

ture

r

P. f

alci

paru

m s

ampl

es (n

=100

)P.

viv

ax s

ampl

es (n

=35)

Tota

l pos

itive

res

ults

a re

turn

edTo

tal p

ositi

ve r

esul

tsa

retu

rned

200

para

sites

/µL

2000

b

para

sites

/μL

200

para

sites

/µL

2000

b

para

sites

/μL

Lot

1Lo

t 2

Lot

1Lo

t 2

Lot

1Lo

t 2

Lot

1Lo

t 2

Test

1Te

st 2

No.

pos

itive

ag

reem

ents

c (m

ax=1

00)

Test

1Te

st 2

No.

pos

itive

ag

reem

ents

c (m

ax=1

00)

Test

1Te

st 2

Test

1Te

st 2

No.

pos

itive

ag

reem

ents

c (m

ax=3

5)Te

st 1

Test

2N

o. p

ositi

ve

agre

emen

tsc

(max

=35)

Test

1Te

st 2

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pan

(HRP

II/pL

DH)

C30R

HA2

5Ra

piG

EN In

c.97

.096

.095

.092

.093

.0 (9

9)89

.0 (9

9)10

0.0

100.

034

.034

.033

.035

.034

.034

.033

.035

.0

Pf a

nd P

vAd

vanc

ed Q

ualit

y ™

One

Ste

p M

alar

ia

(Pf/

Pv)

Tri-

line

Test

(who

le b

lood

)IT

P110

03 TC

40In

Tec

Prod

ucts

, Inc

.82

.0 (9

8)80

.0 (9

9)75

.0 (9

7)82

.079

.0 (9

9)77

.0 (9

9)10

0.0

99.0

(99)

25.0

23.0

20.0

25.0

22.0

20.0

34.0

(34)

35.0

BioT

race

r™ M

alar

ia P

.f/P.

v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

95.0

97.0

94.0

94.0

96.0

92.0

100.

010

0.0

34.0

34.0

33.0

35.0

35.0

35.0

34.0

(34)

35.0

Core

test

s® O

ne S

tep

Mal

aria

Pf/P

v Ag

Test

Dev

ice

B42-

21/B

42-2

2Co

re T

echn

olog

y Co

., Lt

d.88

.088

.084

.086

.0 (9

9)89

.082

.0 (9

9)99

.099

.030

.030

.0 (3

4)28

.0 (3

4)33

.033

.0 (3

4)32

.0 (3

4)35

.035

.0

EzD

x™ M

alar

ia P

v/Pf

Rap

id M

alar

ia a

ntig

en

dete

ctio

n te

stRK

MAL

003

Advy

Che

mic

al P

rivat

e Li

mite

d87

.087

.083

.081

.079

.077

.010

0.0

100.

032

.032

.029

.032

.034

.031

.035

.035

.0

Falc

iVax

™ -

Rap

id T

est f

or M

alar

ia P

v/Pf

5030

1002

5Ze

phyr

Bio

med

ical

s89

.085

.084

.086

.086

.082

.099

.010

0.0

35.0

35.0

35.0

35.0

35.0

35.0

35.0

35.0

Firs

t Res

pons

e® M

alar

ia A

g Pf

/Pv

Card

Tes

tPI

19FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

94.0

92.0

91.0

90.0

91.0

87.0

100.

099

.0 (9

9)32

.032

.030

.031

.033

.029

.035

.035

.0

Hum

asis

Mal

aria

P.f/

P.v

Antig

en T

est

ANM

IV-7

025

Hum

asis

Co.

, Ltd

.82

.093

.091

.091

.094

.091

.010

0.0

100.

034

.034

.033

.033

.034

.033

.035

.035

.0

KHB®

Mal

aria

Ag

P.f/

P.v

Rapi

d Te

stKH

-R-0

7-50

Shan

ghai

Keh

ua B

io-e

ngin

eerin

g Co

., Lt

d.86

.095

.092

.094

.096

.093

.010

0.0

100.

023

.022

.019

.027

.025

.022

.035

.035

.0

Mal

aria

PV/

PF (p

LDH

/HRP

2) A

ntig

en T

est

Inf-

72N

anto

ng E

gens

Bio

tech

nolo

gy

Co.,

Ltd.

95.0

(99)

93.0

(99)

91.0

(98)

94.0

(97)

93.0

89.0

(97)

100.

098

.0 (9

8)30

.028

.025

.031

.0 (3

4)24

.0 (3

3)22

.0 (3

2)34

.035

.0

Mer

iscr

een

Mal

aria

Pf/

Pv A

gM

FLRP

D-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.81

.084

.078

.086

.082

.081

.010

0.0

100.

021

.019

.013

.024

.022

.017

.035

.035

.0

One

Step

Mal

aria

P.f/

P.v

Who

le B

lood

Tes

tW

056-

CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

85.0

86.0

82.0

85.0

85.0

(99)

78.0

(99)

99.0

(100

)10

0.0

1.0

1.0

0.0

5.0

2.0

1.0

31.0

29.0

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

d Te

stR0

112C

CTK

Biot

ech,

Inc.

79.0

83.0

76.0

81.0

82.0

(99)

79.0

(99)

100.

098

.034

.031

.031

.034

.032

.031

.035

.035

.0

Quic

kPro

file™

Mal

aria

Pf/

Pv T

est

7105

0Lu

miq

uick

Dia

gnos

tics,

Inc.

87.0

85.0

84.0

85.0

83.0

80.0

100.

010

0.0

18.0

22.0

14.0

18.0

17.0

13.0

35.0

35.0

Rapi

GEN

BIOC

REDI

T Mal

aria

Ag

Pf/P

v (HR

PII/p

LDH)

C40R

HA2

5Ra

piG

EN In

c.96

.094

.094

.094

.095

.0 (9

9)93

.0 (9

9)10

0.0

100.

034

.035

.034

.033

.035

.033

.035

.035

.0

SD B

iolin

e M

alar

ia A

g P.

f/P.

v05

FK80

Stan

dard

Dia

gnos

tics,

Inc.

96.0

95.0

95.0

94.0

95.0

92.0

100.

010

0.0

33.0

35.0

33.0

35.0

35.0

35.0

35.0

35.0

Pf a

nd P

f an

d Pv

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

vd05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.90

.092

.088

.087

.088

.086

.010

0.0

100.

034

.035

.035

.034

.034

.033

.035

.035

.0

NA,

not

app

licab

lePf

, Pla

smod

ium

falc

ipar

um

Pv,

Plas

mod

ium

viv

ax

pan

, Pla

smod

ium

spec

ies

a Re

sults

are

bas

ed o

n th

e fir

st re

ader

’s in

terp

reta

tion

acco

rdin

g to

man

ufac

ture

r’s in

stru

ctio

ns.

b 3

(3%

) of t

he 1

00 P

. fal

cipa

rum

dilu

tion

sam

ples

set

s w

ere

200

and

5000

par

asite

s/µL

c N

umbe

r of s

ampl

es th

at re

turn

ed a

pos

itive

resu

lt fo

r bot

h te

sts.

Whe

re o

ne te

st w

as in

valid

and

the

othe

r pos

itive

, pos

itive

agr

eem

ent w

as re

cord

ed.

d Re

sults

pre

sent

ed in

the

tabl

e ar

e ba

sed

on a

pos

itive

Pf t

est l

ine

(eith

er H

RP2

or P

f-pL

DH).

Tabl

e A

4.1

(con

tinue

d)


Tabl

e A

4.2:

Dis

trib

utio

n of

tes

t ba

nd in

tens

ity

(0-4

) sc

ores

aga

inst

pha

se-2

wild

-typ

e P.

fal

cipa

rum

sam

ples

at

low

(200

) an

d hi

gh (2

000)

par

asit

e de

nsit

y (p

aras

ites

/μL)

Prod

uct

Prod

uct

code

Man

ufac

ture

r

200

para

sites

/µL

2000

b pa

rasit

es/μ

L20

0 pa

rasit

es/µ

L20

00b

para

sites

/μL

200

para

sites

/µL

2000

b pa

rasit

es/μ

LPe

rcen

tage

dist

ribut

ion

of P

f te

st b

and

inte

nsity

c (n

=400

)

Perc

enta

ge d

istrib

utio

n of

Pf

test

ban

d in

tens

ityc

(n=2

00)

Perc

enta

ge d

istrib

utio

n of

pa

n te

st b

and

inte

nsity

c (n

=400

)

Perc

enta

ge d

istrib

utio

n of

pa

n te

st b

and

inte

nsity

c (n

=200

)

Perc

enta

ge d

istrib

utio

n of

Pv

test

ban

d in

tens

ityc

(n=4

00)

Perc

enta

ge d

istrib

utio

n of

Pv

test

ban

d in

tens

ityc

(n=2

00)

0a1

23

40a

12

34

0a1

23

40a

12

34

0a1

23

40a

12

34

Pf o

nly

BION

OTE

MAL

ARIA

P.f.

Ag

Rapi

d Te

st K

itRG

19-1

1Bi

oNot

e, In

c.7.

012

.832

.832

.515

.00.

00.

04.

021

.574

.5N

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Care

Star

t™ M

alar

ia H

RP2/

pLDH

(Pf)

G01

81/G

0181

-ET

Acce

ss B

io, I

nc.

4.3

13.3

32.0

32.3

18.3

0.5

0.0

2.0

19.5

78.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

EzDx

™ M

alar

ia P

f Rap

id M

alar

ia a

ntig

en

dete

ctio

n te

stRK

MAL

008

Advy

Che

mic

al P

rivat

e Li

mite

d22

.027

.343

.86.

80.

30.

51.

027

.532

.538

.5N

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Firs

t R

espo

nse®

Mal

aria

Ant

igen

P.

falc

ipar

um (H

RP2)

Car

d Te

stPI

13FR

CP

rem

ier

Me

dic

al

Corp

orat

ion

Ltd.

4.8

14.8

33.8

26.5

20.3

0.0

0.0

5.5

20.0

74.5

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Hum

asis

Mal

aria

P.f

Antig

en T

est

ANM

PF-7

025

Hum

asis

Co.

, Ltd

.6.

319

.046

.523

.05.

30.

00.

012

.024

.064

.0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Mal

aria

Ant

igen

Tes

t-Pf

MAG

0104

0Os

car M

edic

are

Pvt.

Ltd.

3.3

8.0

34.3

29.8

24.8

0.0

0.0

2.0

19.5

78.5

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

One

Step

Mal

aria

P.f

Who

le b

lood

Test

W37

-CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

8.0

17.3

42.5

25.5

6.8

0.5

0.0

9.5

24.5

65.5

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

OnSi

te M

alar

ia P

f Ag

Rapi

d Te

stR0

114C

CTK

Biot

ech,

Inc.

19.5

16.3

41.1

20.8

2.2

0.5

1.0

18.5

22.5

57.5

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Rapi

d 1-

2-3®

Hem

a® C

asse

tte M

alar

ia P

FM

AL-P

F-CA

S/25

(1

00)

Hem

a Di

agno

stic

Syst

ems

4.0

12.8

28.5

30.0

24.8

0.0

1.0

1.5

14.0

83.5

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

(H

RPII)

C10R

HA2

5Ra

piG

EN In

c.7.

58.

520

.835

.827

.31.

00.

02.

015

.581

.5N

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Righ

tSig

n® M

alar

ia P

.f. R

apid

Tes

t Ca

sset

te (W

hole

Blo

od)

IMPF

-C51

Hang

zhou

Bio

test

Bio

tech

Co

., Lt

d.13

.326

.845

.513

.80.

80.

01.

020

.033

.046

.0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

SD B

iolin

e M

alar

ia A

g P.f

(HRP

2/pL

DH) -

H

RP2

band

05FK

90St

anda

rd D

iagn

ostic

s, In

c.7.

05.

328

.834

.324

.80.

00.

00.

514

.585

.0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

SD B

iolin

e M

alar

ia A

g P.f

(HRP

2/pL

DH) -

Pf

-pLD

H b

and

05FK

90St

anda

rd D

iagn

ostic

s, In

c.28

.549

.022

.50.

00.

02.

50.

546

.045

.06.

0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Pf a

nd p

an

ATOM

ORAP

ID™

MAL

ARIA

(PF/

PAN

)M

MAL

01At

omo

Diag

nost

ics

PTY

Lim

ited

5.8

13.5

33.8

36.3

10.8

0.0

0.0

2.5

17.0

80.5

76.3

20.3

3.5

0.0

0.0

4.5

25.0

64.0

6.5

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

BION

OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kit

RG19

-08

BioN

ote,

Inc.

12.0

13.5

34.8

34.0

5.8

0.0

0.0

11.0

27.5

61.5

75.0

23.5

1.5

0.0

0.0

4.5

20.0

64.5

11.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

BioT

race

r™ M

alar

ia P

.f/PA

N R

apid

Car

d17

012

Bio

Focu

s Co

., Lt

d.8.

011

.038

.538

.04.

50.

00.

06.

044

.050

.017

.559

.822

.50.

30.

02.

03.

053

.036

.55.

5N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

EzD

x™ M

alar

ia P

an/P

f R

apid

tes

t de

tect

ion

Kit

RK M

AL 0

01Ad

vy C

hem

ical

Priv

ate

Lim

ited

15.3

20.5

39.0

21.0

4.3

0.0

0.5

12.5

24.5

62.5

59.8

39.3

1.0

0.0

0.0

3.5

14.0

75.0

7.0

0.5

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Firs

t Res

pons

e® M

alar

ia A

g. p

LDH/

HRP2

Co

mbo

Car

d Te

stPI

16FR

CPr

emie

r Med

ical

Co

rpor

atio

n Lt

d.8.

315

.829

.826

.020

.30.

00.

02.

517

.080

.525

.363

.311

.50.

00.

02.

511

.559

.022

.54.

5N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Hum

asis

Mal

aria

P.f/

Pan

Antig

en T

est

ANM

AL-7

025

Hum

asis

Co.

, Ltd

.7.

817

.843

.324

.56.

80.

50.

010

.520

.568

.587

.812

.30.

00.

00.

012

.542

.044

.01.

50.

0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Is It

… M

alar

ia P

f/Pv

Dev

ice

AL03

0M

edso

urce

Ozo

ne

Biom

edic

als

5.8

11.0

24.0

28.5

30.8

0.5

0.5

3.5

11.0

84.5

40.0

45.0

14.8

0.0

0.3

5.5

3.0

70.0

20.0

1.5

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.14

.823

.339

.819

.52.

80.

01.

019

.021

.558

.549

.347

.33.

30.

30.

010

.013

.564

.011

.01.

5N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

One

Step

Mal

aria

P.f/

Pan

Who

le B

lood

Te

stW

62-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.14

.321

.841

.519

.53.

00.

02.

014

.526

.057

.594

.55.

30.

30.

00.

034

.038

.028

.00.

00.

0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

OnSi

te M

alar

ia P

f/Pa

n Ag

Rap

id T

est

R011

3CCT

K Bi

otec

h, In

c.16

.518

.341

.620

.82.

80.

51.

519

.522

.556

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.224

.61.

30.

00.

03.

026

.060

.510

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0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Para

scre

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pid

Test

for

Mal

aria

Pa

n/Pf

5030

3002

5Ze

phyr

Bio

med

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s13

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.88.

00.

00.

06.

022

.072

.033

.352

.514

.30.

00.

02.

52.

550

.035

.59.

5N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

An

ne

xes


Prod

uct

Prod

uct

code

Man

ufac

ture

r

200

para

sites

/µL

2000

b pa

rasit

es/μ

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0 pa

rasit

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para

sites

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200

para

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2000

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dist

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of P

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and

inte

nsity

c (n

=400

)

Perc

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Pf

test

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d in

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(n=2

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Perc

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pa

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inte

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c (n

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)

Perc

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pa

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and

inte

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c (n

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)

Perc

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ge d

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Pv

test

ban

d in

tens

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(n=4

00)

Perc

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test

ban

d in

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(n=2

00)

0a1

23

40a

12

34

0a1

23

40a

12

34

0a1

23

40a

12

34

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

Dia

gnos

tics,

Inc.

15.0

18.3

44.8

20.0

2.0

0.5

1.0

17.5

25.0

56.0

25.8

62.8

11.5

0.0

0.0

2.0

10.5

74.0

13.0

0.5

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pan

(H

RPII/

pLDH

) C3

0RH

A25

Rapi

GEN

Inc.

5.3

9.0

26.6

39.6

19.5

0.0

0.0

2.0

16.5

81.5

63.4

34.8

1.8

0.0

0.0

6.0

24.5

62.5

7.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Pf a

nd P

vAd

vanc

ed Q

ualit

y ™

One

Step

Mal

aria

(P

f/Pv

) Tri-

line

Test

(who

le b

lood

)IT

P110

03 T

C40

InTe

c Pr

oduc

ts, I

nc.

19.3

20.3

40.3

16.3

4.0

0.5

2.5

13.0

25.0

59.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

100.

00.

00.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

BioT

race

r™ M

alar

ia P

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v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

4.5

10.8

28.8

43.0

13.0

0.0

0.0

1.0

30.5

68.5

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

100.

00.

00.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

Core

test

s® O

ne S

tep

Mal

aria

Pf/

Pv A

g Te

st D

evic

eB4

2-21

/B42

-22

Core

Tech

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gy C

o., L

td.

12.3

22.0

48.3

15.0

2.5

1.0

0.5

18.5

29.5

50.5

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

97.3

2.5

0.3

0.0

0.0

99.0

1.0

0.0

0.0

0.0

EzD

x™ M

alar

ia P

v/Pf

Rap

id M

alar

ia

antig

en d

etec

tion

test

RK M

AL 0

03Ad

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hem

ical

Priv

ate

Lim

ited

16.5

20.5

39.8

20.0

3.3

0.0

1.0

14.0

24.0

61.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

98.8

1.3

0.0

0.0

0.0

100.

00.

00.

00.

00.

0

Falc

iVax

™ -

Rapi

d Te

st fo

r Mal

aria

Pv/

Pf50

3010

025

Zeph

yr B

iom

edic

als

13.5

11.0

33.0

32.3

10.3

0.5

0.5

7.5

19.5

72.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

99.5

0.5

0.0

0.0

0.0

99.5

0.0

0.0

0.0

0.5

Firs

t Re

spon

se®

Mal

aria

Ag

Pf/P

v Ca

rd T

est

PI19

FRC

Prem

ier M

edic

al

Corp

orat

ion

Ltd.

8.3

17.0

27.0

27.8

20.0

0.5

0.0

2.5

19.5

77.5

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

100.

00.

00.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

Hum

asis

Mal

aria

P.f/

P.v

Antig

en T

est

ANM

IV-7

025

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asis

Co.

, Ltd

.7.

516

.344

.323

.88.

30.

00.

012

.021

.067

.0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A99

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30.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

KHB®

Mal

aria

Ag

P.f/

P.v

Rapi

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stKH

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7-50

Shan

ghai

Keh

ua B

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neer

ing

Co.,

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4.8

12.0

33.0

33.0

17.3

0.0

0.5

3.0

20.5

76.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

99.8

0.3

0.0

0.0

0.0

100.

00.

00.

00.

00.

0

Mal

aria

PV/

PF (p

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HRP2

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igen

Test

Inf

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Nan

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ns

Biot

echn

olog

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., Lt

d.6.

310

.528

.342

.812

.31.

00.

52.

026

.570

.0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A10

0.0

0.0

0.0

0.0

0.0

99.5

0.0

0.5

0.0

0.0

Mer

iscr

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Mal

aria

Pf/

Pv A

gM

FLRP

D-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.16

.820

.344

.515

.82.

80.

01.

018

.527

.553

.0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A98

.02.

00.

00.

00.

096

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02.

50.

50.

0

One S

tep

Mal

aria

P.f/P

.v W

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Blo

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CG

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ech

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14.8

20.8

44.8

18.0

1.8

0.5

1.0

13.0

29.0

56.5

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

100.

00.

00.

00.

00.

094

.53.

52.

00.

00.

0

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

d Te

stR0

112C

CTK

Biot

ech,

Inc.

18.5

20.1

41.1

19.5

0.8

1.0

1.5

17.0

29.0

51.5

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

100.

00.

00.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

Quic

kPro

file™

Mal

aria

Pf/

Pv T

est

7105

0Lu

miq

uick

Dia

gnos

tics,

Inc.

15.0

16.8

41.5

22.5

4.3

0.0

1.5

13.5

28.0

57.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

96.0

3.0

1.0

0.0

0.0

96.0

0.0

3.5

0.5

0.0

Rapi

GEN

BIO

CRED

IT M

alar

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g Pf

/Pv

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DH)

C40R

HA2

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527

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00.

01.

516

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AN

AN

AN

AN

AN

AN

AN

AN

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A97

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00.

099

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0

SD B

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alar

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FK80

Stan

dard

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gnos

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31.3

38.3

14.8

0.0

0.0

2.0

23.0

75.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

99.5

0.3

0.3

0.0

0.0

100.

00.

00.

00.

00.

0

Pf a

nd P

f an

d Pv

SD B

iolin

e M

alar

ia A

g P.

f/P.f/

P.v

- HRP

2 an

d Pv

ban

d05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.11

.07.

326

.336

.319

.30.

00.

02.

017

.081

.0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A10

0.0

0.0

0.0

0.0

0.0

99.5

0.5

0.0

0.0

0.0

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v -

Pf-

pLDH

ban

d05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.43

.340

.316

.50.

00.

02.

01.

543

.046

.57.

0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

NA,

not

app

licab

lePf

, Pla

smod

ium

falc

ipar

um

Pv,

Plas

mod

ium

viv

ax

pan

, Pla

smod

ium

spec

ies

a De

note

s no

vis

ible

ban

d b

3 (3

%) o

f the

100

P. f

alci

paru

m d

ilutio

n sa

mpl

es s

ets

wer

e 20

0 an

d 50

00 p

aras

ites/

µLc

Calc

ulat

ions

incl

ude

inva

lid te

sts

Tabl

e A

4.2

(con

tinue

d)


Tabl

e A

4.3:

Dis

trib

utio

n of

pan

/Pv

test

ban

d in

tens

ity

(0-4

) sc

ores

for

pha

se-2

wild

-typ

e P.

viv

ax s

ampl

es a

t lo

w (2

00)

and

high

(200

0) p

aras

ite

dens

ity

(par

asit

es/μ

L)

Prod

uct

Prod

uct

code

Man

ufac

ture

r

200

para

sites

/µL

2000

par

asite

s/µL

200

para

sites

/µL

2000

par

asite

s/µL

200

para

sites

/µL

2000

par

asite

s/µL

Perc

enta

ge d

istrib

utio

n of

Pf

test

ban

d in

tens

ityb

(n=1

40)

Perc

enta

ge d

istrib

utio

n of

Pf

test

ban

d in

tens

ityb

(n=7

0)

Perc

enta

ge d

istrib

utio

n of

pa

n te

st b

and

inte

nsity

b (n

=140

)

Perc

enta

ge d

istrib

utio

n of

pa

n te

st b

and

inte

nsity

b (n

=70)

Perc

enta

ge d

istrib

utio

n of

Pv

test

ban

d in

tens

ityb

(n=1

40)

Perc

enta

ge d

istrib

utio

n of

Pv

test

ban

d in

tens

ityb

(n=7

0)

0a1

23

40a

12

34

0a1

23

40a

12

34

0a1

23

40a

12

34

Pf o

nly

BION

OTE

MAL

ARIA

P.f.

Ag R

apid

Test

Kit

RG19

-11

BioN

ote,

Inc.

100.

00.

00.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Care

Star

t™ M

alar

ia H

RP2/

pLDH

(Pf)

G01

81Ac

cess

Bio

, Inc

.98

.61.

40.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

EzDx

™ M

alar

ia P

f Rap

id M

alar

ia a

ntig

en

dete

ctio

n te

stRK

MAL

008

Advy

Che

mic

al P

rivat

e Li

mite

d98

.61.

40.

00.

00.

098

.61.

40.

00.

00.

0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Firs

t R

espo

nse®

Mal

aria

Ant

igen

P.

falc

ipar

um (H

RP2)

Car

d Te

stPI

13FR

CPr

emie

r Med

ical

Co

rpor

atio

n Lt

d.10

0.0

0.0

0.0

0.0

0.0

100.

00.

00.

00.

00.

0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Hum

asis

Mal

aria

P.f

Antig

en T

est

ANM

PF-7

025

Hum

asis

Co.

, Ltd

.98

.61.

40.

00.

00.

098

.61.

40.

00.

00.

0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Mal

aria

Ant

igen

Tes

t-Pf

MAG

0104

0Os

car M

edic

are

Pvt.

Ltd.

98.6

1.4

0.0

0.0

0.0

98.6

1.4

0.0

0.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

One

Step

Mal

aria

P.f

Who

le b

lood

Test

W37

-CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

100.

00.

00.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

OnSi

te M

alar

ia P

f Ag

Rapi

d Te

stR0

114C

CTK

Biot

ech,

Inc.

100.

00.

00.

00.

00.

098

.60.

01.

40.

00.

0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Rapi

d 1-

2-3®

Hem

a® C

asse

tte

Mal

aria

PF

MAL

-PF-

CAS/

25

(100

)He

ma

Diag

nost

ic Sy

stem

s97

.12.

90.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

(H

RPII)

C10R

HA2

5Ra

piG

EN In

c.99

.30.

00.

00.

70.

010

0.0

0.0

0.0

0.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Righ

tSig

n® M

alar

ia P

.f. R

apid

Tes

t Ca

sset

te (W

hole

Blo

od)

IMPF

-C51

Han

gzho

u Bi

otes

t Bi

otec

h Co

., Lt

d.10

0.0

0.0

0.0

0.0

0.0

100.

00.

00.

00.

00.

0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

SD B

iolin

e M

alar

ia A

g P.

f (HR

P2/p

LDH)

-

HRP

2 ba

nd05

FK90

Stan

dard

Dia

gnos

tics,

Inc.

99.3

0.0

0.7

0.0

0.0

100.

00.

00.

00.

00.

0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

SD B

iolin

e M

alar

ia A

g P.

f (HR

P2/p

LDH)

-

Pf p

LDH

ban

d05

FK90

Stan

dard

Dia

gnos

tics,

Inc.

100.

00.

00.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Pf a

nd p

an

ATOM

ORAP

ID™

MAL

ARIA

(PF/

PAN

)M

MAL

01At

omo

Diag

nost

ics

PTY

Lim

ited

97.1

2.9

0.0

0.0

0.0

100.

00.

00.

00.

00.

047

.942

.99.

30.

00.

01.

40.

057

.131

.410

.0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

BION

OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kit

RG19

-08

BioN

ote,

Inc.

100.

00.

00.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

19.3

51.4

29.3

0.0

0.0

0.0

0.0

28.6

55.7

15.7

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

BioT

race

r™ M

alar

ia P

.f/PA

N R

apid

Car

d17

012

Bio

Focu

s Co

., Lt

d.10

0.0

0.0

0.0

0.0

0.0

100.

00.

00.

00.

00.

00.

09.

384

.36.

40.

00.

00.

01.

430

.068

.6N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

EzD

x™ M

alar

ia P

an/P

f Ra

pid

test

de

tect

ion

Kit

RK M

AL 0

01Ad

vy C

hem

ical

Priv

ate

Lim

ited

100.

00.

00.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

2.9

48.6

47.9

0.7

0.0

0.0

0.0

20.0

54.3

25.7

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Firs

t Re

spon

se®

Mal

aria

Ag.

pLD

H/

HRP

2 Co

mbo

Car

d Te

stPI

16FR

CPr

emie

r Med

ical

Co

rpor

atio

n Lt

d.10

0.0

0.0

0.0

0.0

0.0

100.

00.

00.

00.

00.

02.

121

.467

.19.

30.

00.

01.

48.

630

.060

.0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Hum

asis

Mal

aria

P.f/

Pan

Antig

en Te

stAN

MAL

-702

5H

umas

is C

o., L

td.

99.3

0.7

0.0

0.0

0.0

98.6

1.4

0.0

0.0

0.0

15.7

67.9

16.4

0.0

0.0

0.0

0.0

52.9

38.6

8.6

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Is It

… M

alar

ia P

f/Pv

Dev

ice

AL03

0M

edso

urce

Ozo

ne

Biom

edic

als

100.

00.

00.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

2.1

10.0

76.4

11.4

0.0

2.9

0.0

4.3

34.3

58.6

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.10

0.0

0.0

0.0

0.0

0.0

100.

00.

00.

00.

00.

015

.767

.916

.40.

00.

00.

01.

447

.144

.37.

1N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

One

Step

Mal

aria

P.f/

Pan

Who

le B

lood

Te

stW

62-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.10

0.0

0.0

0.0

0.0

0.0

100.

00.

00.

00.

00.

061

.437

.90.

70.

00.

00.

011

.464

.324

.30.

0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

OnSi

te M

alar

ia P

f/P a

n Ag

Rap

id T

est

R011

3CCT

K Bi

otec

h, In

c.10

0.0

0.0

0.0

0.0

0.0

98.6

0.0

1.4

0.0

0.0

3.6

62.1

34.3

0.0

0.0

0.0

1.4

22.9

54.3

21.4

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

An

ne

xes


Prod

uct

Prod

uct

code

Man

ufac

ture

r

200

para

sites

/µL

2000

par

asite

s/µL

200

para

sites

/µL

2000

par

asite

s/µL

200

para

sites

/µL

2000

par

asite

s/µL

Perc

enta

ge d

istrib

utio

n of

Pf

test

ban

d in

tens

ityb

(n=1

40)

Perc

enta

ge d

istrib

utio

n of

Pf

test

ban

d in

tens

ityb

(n=7

0)

Perc

enta

ge d

istrib

utio

n of

pa

n te

st b

and

inte

nsity

b (n

=140

)

Perc

enta

ge d

istrib

utio

n of

pa

n te

st b

and

inte

nsity

b (n

=70)

Perc

enta

ge d

istrib

utio

n of

Pv

test

ban

d in

tens

ityb

(n=1

40)

Perc

enta

ge d

istrib

utio

n of

Pv

test

ban

d in

tens

ityb

(n=7

0)

0a1

23

40a

12

34

0a1

23

40a

12

34

0a1

23

40a

12

34

Para

scre

en®

- Ra

pid

Test

for

Mal

aria

Pa

n/Pf

5030

3002

5Ze

phyr

Bio

med

ical

s10

0.0

0.0

0.0

0.0

0.0

100.

00.

00.

00.

00.

00.

75.

078

.612

.13.

60.

00.

00.

021

.478

.6N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

Dia

gnos

tics,

Inc.

98.6

1.4

0.0

0.0

0.0

100.

00.

00.

00.

00.

00.

724

.372

.92.

10.

00.

00.

07.

151

.441

.4N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pa

n (H

RPII/

pLDH

) C3

0RH

A25

Rapi

GEN

Inc.

100.

00.

00.

00.

00.

097

.12.

90.

00.

00.

02.

157

.140

.70.

00.

00.

00.

030

.048

.621

.4N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A

Pf a

nd P

vAd

vanc

ed Q

ualit

y ™

One

Step

Mal

aria

(P

f/Pv

) Tri-

line

Test

(who

le b

lood

)IT

P110

03 T

C40

InTe

c Pr

oduc

ts, I

nc.

100.

00.

00.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

32.1

57.1

10.7

0.0

0.0

1.4

7.1

42.9

32.9

15.7

BioT

race

r™ M

alar

ia P

.f/P.

v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

100.

00.

00.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

1.4

57.1

41.4

0.0

0.0

1.4

0.0

12.9

67.1

18.6

Core

test

s® O

ne S

tep

Mal

aria

Pf/

Pv

Ag T

est D

evic

eB4

2-21

/B42

-22

Core

Tech

nolo

gy C

o., L

td.

100.

00.

00.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

10.0

61.4

28.6

0.0

0.0

0.0

0.0

20.0

57.1

22.9

EzD

x™ M

alar

ia P

v/Pf

Rap

id M

alar

ia

antig

en d

etec

tion

test

RK M

AL 0

03Ad

vy C

hem

ical

Priv

ate

Lim

ited

98.6

1.4

0.0

0.0

0.0

98.6

1.4

0.0

0.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

7.1

75.7

17.1

0.0

0.0

0.0

0.0

47.1

40.0

12.9

Falc

iVax

™ -

Rapi

d Te

st fo

r Mal

aria

Pv/

Pf50

3010

025

Zeph

yr B

iom

edic

als

100.

00.

00.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

0.0

7.1

75.0

16.4

1.4

0.0

0.0

0.0

22.9

77.1

Firs

t Re

spon

se®

Mal

aria

Ag

Pf/P

v Ca

rd T

est

PI19

FRC

Prem

ier M

edic

al

Corp

orat

ion

Ltd.

100.

00.

00.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

8.6

50.7

40.7

0.0

0.0

0.0

0.0

21.4

42.9

35.7

Hum

asis

Mal

aria

P.f/

P.v

Antig

en T

est

ANM

IV-7

025

Hum

asis

Co.

, Ltd

.99

.30.

70.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

3.6

54.3

40.7

1.4

0.0

0.0

0.0

17.1

57.1

25.7

KHB®

Mal

aria

Ag

P.f/

P.v

Rapi

d Te

stKH

-R-0

7-50

Shan

ghai

Keh

ua B

io-

engi

neer

ing

Co.,

Ltd.

100.

00.

00.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

30.7

52.1

17.1

0.0

0.0

0.0

0.0

60.0

34.3

5.7

Mal

aria

PV/

PF (p

LDH/

HRP2

) Ant

igen

Test

In

f-72

Nan

tong

Ege

ns

Biot

echn

olog

y Co

., Lt

d.10

0.0

0.0

0.0

0.0

0.0

100.

00.

00.

00.

00.

0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A19

.345

.035

.70.

00.

01.

40.

042

.944

.311

.4

Mer

iscr

een

Mal

aria

Pf/

Pv A

gM

FLRP

D-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.99

.30.

70.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

38.6

57.9

3.6

0.0

0.0

0.0

8.6

75.7

15.7

0.0

One

Step

Mal

aria

P.f/

P.v

Who

le B

lood

Te

stW

056-

CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

100.

00.

00.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

93.6

6.4

0.0

0.0

0.0

14.3

48.6

34.3

2.9

0.0

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

d Te

stR0

112C

CTK

Biot

ech,

Inc.

98.6

1.4

0.0

0.0

0.0

100.

00.

00.

00.

00.

0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A6.

467

.925

.70.

00.

00.

00.

032

.951

.415

.7

Quic

kPro

file™

Mal

aria

Pf/

Pv T

est

7105

0Lu

miq

uick

Dia

gnos

tics,

Inc.

100.

00.

00.

00.

00.

010

0.0

0.0

0.0

0.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

46.4

47.9

5.7

0.0

0.0

0.0

1.4

78.6

20.0

0.0

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pv

(HRP

II/pL

DH)

C40R

HA2

5Ra

piG

EN In

c.10

0.0

0.0

0.0

0.0

0.0

97.1

2.9

0.0

0.0

0.0

NA

NA

NA

NA

NA

NA

NA

NA

NA

NA

2.1

50.7

46.4

0.7

0.0

0.0

0.0

30.0

38.6

31.4

SD B

iolin

e M

alar

ia A

g P.

f/P.

v05

FK80

Stan

dard

Dia

gnos

tics,

Inc.

99.3

0.7

0.0

0.0

0.0

100.

00.

00.

00.

00.

0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A1.

410

.075

.013

.60.

00.

00.

02.

922

.974

.3

Pf a

nd P

f an

d Pv

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.10

0.0

0.0

0.0

0.0

0.0

100.

00.

00.

00.

00.

0N

AN

AN

AN

AN

AN

AN

AN

AN

AN

A2.

115

.072

.910

.00.

00.

00.

00.

027

.172

.9

NA,

not

app

licab

lePf

, Pla

smod

ium

falc

ipar

um

Pv,

Plas

mod

ium

viv

ax

pan

, Pla

smod

ium

spec

ies

a De

note

s no

vis

ible

ban

d b

Calc

ulat

ions

incl

ude

inva

lid te

sts

Tabl

e A

4.3

(con

tinue

d)


Tabl

e A

4.4:

Pha

se 2

P. f

alci

paru

m t

est

line

fals

e-po

siti

ve r

ates

for

wild

-typ

e P.

viv

ax s

ampl

es a

t lo

w (2

00)

and

high

(200

0) p

aras

ite

dens

ity

(par

asit

es/µ

L)

Prod

uct

Prod

uct

code

Man

ufac

ture

r

P. v

ivax

sam

ples

(n=3

5)20

0 pa

rasit

es/µ

L20

00 p

aras

ites/

µLFa

lse p

ositi

ve P

f in

fect

iona

(%)

False

pos

itive

Pf

infe

ctio

na (%

)

Lot

1 (n

=70)

Lot

2 (n

=70)

Ove

rall

(n=1

40)

Lot

1 (n

=35)

Lot

2 (n

=35)

Ove

rall

(n=7

0)Pf

onl

yBI

ONOT

E M

ALAR

IA P

.f. A

g Ra

pid

Test

Kit

RG19

-11

BioN

ote,

Inc.

0.0

0.0

0.0

0.0

0.0

0.0

Care

Star

t™ M

alar

ia H

RP2/

pLDH

(Pf)

G01

81/G

0181

-ET

Acce

ss B

io, I

nc.

1.4

0.0

0.7

0.0

0.0

0.0

EzDx

™ M

alar

ia P

f Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

08Ad

vy C

hem

ical

Priv

ate

Lim

ited

2.9

0.0

1.4

0.0

2.9

1.4

Firs

t Res

pons

e® M

alar

ia A

ntig

en P

. fal

cipa

rum

(HRP

2) C

ard

Test

PI13

FRC

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.0.

00.

00.

00.

00.

00.

0

Hum

asis

Mal

aria

P.f

Antig

en T

est

ANM

PF-7

025

Hum

asis

Co.

, Ltd

.2.

90.

01.

40.

02.

91.

4

Mal

aria

Ant

igen

Tes

t-Pf

MAG

0104

0Os

car M

edic

are

Pvt.

Ltd.

1.4

1.4

1.4

2.9

0.0

1.4

One

Step

Mal

aria

P.f

Who

le b

lood

Tes

tW

37-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.0.

00.

00.

00.

00.

00.

0

OnSi

te M

alar

ia P

f Ag

Rapi

d Te

stR0

114C

CTK

Biot

ech,

Inc.

0.0

0.0

0.0

0.0

0.0

0.0

Rapi

d 1-

2-3®

Hem

a® C

asse

tte

Mal

aria

PF

MAL

-PF-

CAS/

25 (1

00)

Hem

a Di

agno

stic

Sys

tem

s4.

31.

4 (6

9)2.

9 (1

39)

0.0

0.0

0.0

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

(HRP

II)C1

0RH

A25

Rapi

GEN

Inc.

1.4

0.0

0.7

0.0

0.0

0.0

Righ

tSig

n® M

alar

ia P

.f. R

apid

Tes

t Cas

sett

e (W

hole

Blo

od)

IMPF

-C51

Han

gzho

u Bi

otes

t Bio

tech

Co.

, Ltd

.0.

00.

00.

00.

00.

00.

0

SD B

iolin

e M

alar

ia A

g P.

f (H

RP2/

pLDH

) - H

RP2

band

05FK

90St

anda

rd D

iagn

ostic

s, In

c.1.

40.

00.

70.

00.

00.

0

SD B

iolin

e M

alar

ia A

g P.

f (H

RP2/

pLDH

) - P

f-pL

DH b

and

05FK

90St

anda

rd D

iagn

ostic

s, In

c.0.

00.

00.

00.

00.

00.

0

Pf a

nd p

anAT

OMOR

APID

™ M

ALAR

IA (P

F/PA

N)

MM

AL01

Atom

o Di

agno

stic

s PT

Y Li

mite

d2.

92.

92.

90.

00.

00.

0

BION

OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kit

RG19

-08

BioN

ote,

Inc.

0.0

0.0

0.0

0.0

0.0

0.0

BioT

race

r™ M

alar

ia P

.f/PA

N R

apid

Car

d17

012

Bio

Focu

s Co

., Lt

d.0.

00.

00.

00.

00.

00.

0

EzDx

™ M

alar

ia P

an/P

f Rap

id te

st d

etec

tion

Kit

RK M

AL 0

01Ad

vy C

hem

ical

Priv

ate

Lim

ited

0.0

0.0

0.0

0.0

0.0

0.0

Firs

t Res

pons

e® M

alar

ia A

g. p

LDH

/HRP

2 Co

mbo

Car

d Te

stPI

16FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

0.0

0.0

0.0

0.0

0.0

0.0

Hum

asis

Mal

aria

P.f/

Pan

Antig

en T

est

ANM

AL-7

025

Hum

asis

Co.

, Ltd

.1.

40.

0 (6

9)0.

7 (1

39)

0.0

2.9

1.4

Is It

… M

alar

ia P

f/Pv

Dev

ice

AL03

0M

edso

urce

Ozo

ne B

iom

edic

als

0.0

0.0

0.0

0.0

(34)

0.0

(34)

0.0

(68)

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.0.

00.

00.

00.

00.

00.

0

One

Step

Mal

aria

P.f/

Pan

Who

le B

lood

Tes

tW

62-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.0.

00.

00.

00.

00.

00.

0

OnSi

te M

alar

ia P

f/Pa

n Ag

Rap

id T

est

R011

3CCT

K Bi

otec

h, In

c.0.

00.

00.

00.

02.

91.

4

Para

scre

en®

- Ra

pid

Test

for M

alar

ia P

an/P

f50

3030

025

Zeph

yr B

iom

edic

als

0.0

0.0

0.0

0.0

0.0

0.0

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

Dia

gnos

tics,

Inc.

1.4

1.4

1.4

0.0

0.0

0.0

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pan

(HRP

II/pL

DH)

C30R

HA2

5Ra

piG

EN In

c.0.

00.

00.

05.

70.

02.

9

Pf a

nd P

vAd

vanc

ed Q

ualit

y ™

One

Step

Mal

aria

(Pf

/Pv)

Tri-

line

Test

(who

le

bloo

d)IT

P110

03 T

C40

InTe

c Pr

oduc

ts, I

nc.

0.0

0.0

0.0

0.0

(34)

0.0

0.0

(69)

BioT

race

r™ M

alar

ia P

.f/P.

v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

0.0

0.0

0.0

0.0

(34)

0.0

0.0

(69)

Core

test

s® O

ne S

tep

Mal

aria

Pf/

Pv A

g Te

st D

evic

eB4

2-21

/B42

-22

Core

Tec

hnol

ogy

Co.,

Ltd.

0.0

(69)

0.0

(69)

0.0

(138

)0.

00.

00.

0

EzDx

™ M

alar

ia P

v/Pf

Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

03Ad

vy C

hem

ical

Priv

ate

Lim

ited

0.0

2.9

1.4

0.0

2.9

1.4

Falc

iVax

™ -

Rap

id T

est f

or M

alar

ia P

v/Pf

5030

1002

5Ze

phyr

Bio

med

ical

s0.

00.

00.

00.

00.

00.

0

Firs

t Res

pons

e® M

alar

ia A

g Pf

/Pv

Card

Tes

tPI

19FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

0.0

0.0

0.0

0.0

0.0

0.0

An

ne

xes


Prod

uct

Prod

uct

code

Man

ufac

ture

r

P. v

ivax

sam

ples

(n=3

5)20

0 pa

rasit

es/µ

L20

00 p

aras

ites/

µLFa

lse p

ositi

ve P

f in

fect

iona

(%)

False

pos

itive

Pf

infe

ctio

na (%

)

Lot

1 (n

=70)

Lot

2 (n

=70)

Ove

rall

(n=1

40)

Lot

1 (n

=35)

Lot

2 (n

=35)

Ove

rall

(n=7

0)H

umas

is M

alar

ia P

.f/P.

v An

tigen

Tes

tAN

MIV

-702

5H

umas

is C

o., L

td.

1.4

0.0

0.7

0.0

0.0

0.0

KHB®

Mal

aria

Ag

P.f/

P.v

Rapi

d Te

stKH

-R-0

7-50

Shan

ghai

Keh

ua B

io-e

ngin

eerin

g Co

., Lt

d.0.

00.

00.

00.

00.

00.

0

Mal

aria

PV/

PF (p

LDH

/HRP

2) A

ntig

en T

est

Inf-

72N

anto

ng E

gens

Bio

tech

nolo

gy C

o., L

td.

0.0

0.0

(67)

0.0

(137

)0.

00.

00.

0

Mer

iscr

een

Mal

aria

Pf/

Pv A

gM

FLRP

D-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.0.

01.

40.

70.

00.

00.

0

One

Step

Mal

aria

P.f/

P.v

Who

le B

lood

Tes

tW

056-

CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

0.0

0.0

0.0

0.0

0.0

0.0

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

d Te

stR0

112C

CTK

Biot

ech,

Inc.

1.4

1.4

1.4

0.0

0.0

0.0

Quic

kPro

file™

Mal

aria

Pf/

Pv T

est

7105

0Lu

miq

uick

Dia

gnos

tics,

Inc.

0.0

0.0

0.0

0.0

0.0

0.0

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pv

(HRP

II/pL

DH)

C40R

HA2

5Ra

piG

EN In

c.0.

00.

00.

05.

70.

02.

9

SD B

iolin

e M

alar

ia A

g P.

f/P.

v05

FK80

Stan

dard

Dia

gnos

tics,

Inc.

0.0

1.4

0.7

0.0

0.0

0.0

Pf a

nd P

f an

d Pv

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v -

HRP

2 ba

nd05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.0.

00.

00.

00.

00.

00.

0

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v -

Pf-p

LDH

ban

d05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.0.

00.

00.

00.

00.

00.

0

Pf, P

lasm

odiu

m fa

lcip

arum

P

v, Pl

asm

odiu

m v

ivax

p

an, P

lasm

odiu

m sp

ecie

sa

Pf p

ositi

ve li

ne in

dica

tes

a fa

lse-

posi

tive

P. fa

lcip

arum

infe

ctio

n

Tabl

e A

4.4

(con

tinue

d)


Tabl

e A

4.5:

Pha

se 2

pan

(or

P. v

ivax

) te

st li

ne f

alse

-pos

itive

rat

e fo

r no

n-P.

falc

ipar

um in

fect

ion

on p

hase

2 w

ild-t

ype

P. fa

lcip

arum

sam

ples

at

low

(200

) an

d hi

gh (2

000)

par

asit

e de

nsit

y (p

aras

ites

/µL)

Prod

uct

Prod

uct

code

Man

ufac

ture

r

P. fa

lcip

arum

sam

ples

(n=1

00)

200

para

sites

/µL

2000

a pa

rasit

es/µ

LFa

lse

posi

tive

non-

Pf in

fect

ion

(%)

Fals

e po

sitiv

e no

n-Pf

infe

ctio

n (%

)

Lot

1 (n

=200

)Lo

t 2

(n=2

00)

Ove

rall

(n=4

00)

Lot

1 (n

=100

)Lo

t 2

(n=1

00)

Ove

rall

(n=2

00)

Pf o

nly

BION

OTE

MAL

ARIA

P.f.

Ag

Rapi

d Te

st K

itRG

19-1

1Bi

oNot

e, In

c.N

AN

AN

AN

AN

AN

A

Care

Star

t™ M

alar

ia H

RP2/

pLDH

(Pf)

G01

81/G

0181

-ET

Acce

ss B

io, I

nc.

NA

NA

NA

NA

NA

NA

EzDx

™ M

alar

ia P

f Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

08Ad

vy C

hem

ical

Priv

ate

Lim

ited

NA

NA

NA

NA

NA

NA

Firs

t Res

pons

e® M

alar

ia A

ntig

en P

. fal

cipa

rum

(HRP

2) C

ard

Test

PI13

FRC

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.N

AN

AN

AN

AN

AN

A

Hum

asis

Mal

aria

P.f

Antig

en T

est

ANM

PF-7

025

Hum

asis

Co.

, Ltd

.N

AN

AN

AN

AN

AN

A

Mal

aria

Ant

igen

Tes

t-Pf

MAG

0104

0Os

car M

edic

are

Pvt.

Ltd.

NA

NA

NA

NA

NA

NA

One

Step

Mal

aria

P.f

Who

le b

lood

Tes

tW

37-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.N

AN

AN

AN

AN

AN

A

OnSi

te M

alar

ia P

f Ag

Rapi

d Te

stR0

114C

CTK

Biot

ech,

Inc.

NA

NA

NA

NA

NA

NA

Rapi

d 1-

2-3®

Hem

a® C

asse

tte

Mal

aria

PF

MAL

-PF-

CAS/

25 (1

00)

Hem

a Di

agno

stic

Sys

tem

sN

AN

AN

AN

AN

AN

A

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

(HRP

II)C1

0RH

A25

Rapi

GEN

Inc.

NA

NA

NA

NA

NA

NA

Righ

tSig

n® M

alar

ia P

.f. R

apid

Tes

t Cas

sett

e (W

hole

Blo

od)

IMPF

-C51

Han

gzho

u Bi

otes

t Bio

tech

Co.

, Ltd

.N

AN

AN

AN

AN

AN

A

SD B

iolin

e M

alar

ia A

g P.

f (H

RP2/

pLDH

)05

FK90

Stan

dard

Dia

gnos

tics,

Inc.

NA

NA

NA

NA

NA

NA

Pf a

nd p

anAT

OMOR

APID

™ M

ALAR

IA (P

F/PA

N)

MM

AL01

Atom

o Di

agno

stic

s PT

Y Li

mite

d0.

00.

0 (1

99)

0.0

(399

)0.

00.

00.

0

BION

OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kit

RG19

-08

BioN

ote,

Inc.

0.0

0.0

0.0

0.0

0.0

0.0

BioT

race

r™ M

alar

ia P

.f/PA

N R

apid

Car

d17

012

Bio

Focu

s Co

., Lt

d.3.

05.

04.

00.

00.

00.

0

EzDx

™ M

alar

ia P

an/P

f Rap

id te

st d

etec

tion

Kit

RK M

AL 0

01Ad

vy C

hem

ical

Priv

ate

Lim

ited

0.0

0.5

0.3

0.0

0.0

0.0

Firs

t Res

pons

e® M

alar

ia A

g. p

LDH

/HRP

2 Co

mbo

Car

d Te

stPI

16FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

1.5

1.5

1.5

0.0

0.0

0.0

Hum

asis

Mal

aria

P.f/

Pan

Antig

en T

est

ANM

AL-7

025

Hum

asis

Co.

, Ltd

.0.

00.

00.

00.

00.

00.

0

Is It

… M

alar

ia P

f/Pv

Dev

ice

AL03

0M

edso

urce

Ozo

ne B

iom

edic

als

1.0

(196

)0.

0 (1

99)

0.5

(395

)0.

00.

00.

0

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.1.

51.

01.

30.

00.

00.

0

One

Step

Mal

aria

P.f/

Pan

Who

le B

lood

Tes

tW

62-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.0.

00.

00.

00.

00.

00.

0

OnSi

te M

alar

ia P

f/Pa

n Ag

Rap

id T

est

R011

3CCT

K Bi

otec

h, In

c.0.

0 (1

99)

0.0

(199

)0.

0 (3

98)

0.0

1.0

0.5

Para

scre

en®

- Ra

pid

Test

for M

alar

ia P

an/P

f50

3030

025

Zeph

yr B

iom

edic

als

0.5

4.0

2.3

0.0

0.0

0.0

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

Dia

gnos

tics,

Inc.

5.0

8.0

3.5

1.0

0.0

(99)

0.5

(199

)

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pan

(HRP

II/pL

DH)

C30R

HA2

5Ra

piG

EN In

c.0.

00.

0 (1

99)

0.0

(399

)0.

00.

00.

0

Pf a

nd P

vAd

vanc

ed Q

ualit

y ™

One

Step

Mal

aria

(Pf

/Pv)

Tri-

line

Test

(w

hole

blo

od)

ITP1

1003

TC4

0In

Tec

Prod

ucts

, Inc

.0.

0 (1

97)

0.0

(199

)0.

0 (3

96)

0.0

0.0

(99)

0.0

(199

)

BioT

race

r™ M

alar

ia P

.f/P.

v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

0.0

0.0

0.0

0.0

0.0

0.0

Core

test

s® O

ne S

tep

Mal

aria

Pf/

Pv A

g Te

st D

evic

eB4

2-21

/B42

-22

Core

Tec

hnol

ogy

Co.,

Ltd.

3.0

2.5

(199

)2.

8 (3

99)

1.0

1.0

1.0

EzDx

™ M

alar

ia P

v/Pf

Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

03Ad

vy C

hem

ical

Priv

ate

Lim

ited

0.0

2.5

1.3

0.0

0.0

0.0

Falc

iVax

™ -

Rap

id T

est f

or M

alar

ia P

v/Pf

5030

1002

5Ze

phyr

Bio

med

ical

s0.

50.

50.

51.

00.

00.

5

Firs

t Res

pons

e® M

alar

ia A

g Pf

/Pv

Card

Tes

tPI

19FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

0.0

0.0

0.0

0.0

0.0

(99)

0.0

(199

)

Hum

asis

Mal

aria

P.f/

P.v

Antig

en T

est

ANM

IV-7

025

Hum

asis

Co.

, Ltd

.0.

50.

00.

30.

00.

00.

0

KHB®

Mal

aria

Ag

P.f/

P.v

Rapi

d Te

stKH

-R-0

7-50

Shan

ghai

Keh

ua B

io-e

ngin

eerin

g Co

., Lt

d.0.

50.

00.

30.

00.

00.

0

An

ne

xes


Prod

uct

Prod

uct

code

Man

ufac

ture

r

P. fa

lcip

arum

sam

ples

(n=1

00)

200

para

sites

/µL

2000

a pa

rasit

es/µ

LFa

lse

posi

tive

non-

Pf in

fect

ion

(%)

Fals

e po

sitiv

e no

n-Pf

infe

ctio

n (%

)

Lot

1 (n

=200

)Lo

t 2

(n=2

00)

Ove

rall

(n=4

00)

Lot

1 (n

=100

)Lo

t 2

(n=1

00)

Ove

rall

(n=2

00)

Mal

aria

PV/

PF (p

LDH

/HRP

2) A

ntig

en T

est

Inf-

72N

anto

ng E

gens

Bio

tech

nolo

gy C

o., L

td.

0.0

(198

)0.

0 (1

97)

0.0

(395

)1.

00.

0 (9

8)0.

5 (1

98)

Mer

iscr

een

Mal

aria

Pf/

Pv A

gM

FLRP

D-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.4.

00.

02.

08.

00.

04.

0

One

Step

Mal

aria

P.f/

P.v

Who

le B

lood

Tes

tW

056-

CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

0.0

0.0

(199

)0.

0 (3

99)

11.0

0.0

5.5

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

d Te

stR0

112C

CTK

Biot

ech,

Inc.

0.0

0.0

(199

)0.

0 (3

99)

0.0

0.0

0.0

Quic

kPro

file™

Mal

aria

Pf/

Pv T

est

7105

0Lu

miq

uick

Dia

gnos

tics,

Inc.

7.5

0.5

4.0

7.0

1.0

4.0

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pv

(HRP

II/pL

DH)

C40R

HA2

5Ra

piG

EN In

c.4.

50.

5 (1

99)

2.5

(399

)2.

00.

01.

0

SD B

iolin

e M

alar

ia A

g P.

f/P.

v05

FK80

Stan

dard

Dia

gnos

tics,

Inc.

1.0

0.0

0.5

0.0

0.0

0.0

Pf a

nd P

f an

d Pv

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.0.

00.

00.

00.

01.

00.

5

NA,

not

app

licab

lePf

, Pla

smod

ium

falc

ipar

um

Pv,

Plas

mod

ium

viv

ax

pan

, Pla

smod

ium

spec

ies

a 3

(3%

) of t

he 1

00 P

. fal

cipa

rum

dilu

tion

sam

ples

set

s w

ere

200

and

5000

par

asite

s/µL

Tabl

e A

4.5

(con

tinue

d)


Tabl

e A

4.6:

Pha

se 2

fal

se-p

ositi

ve r

ate

for

P. fa

lcip

arum

tes

t lin

e re

sult

s on

all

mal

aria

-neg

ativ

e sa

mpl

es

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Perc

enta

ge o

f fa

lse-p

ositi

ve P

f te

st li

nes

on “

clea

n”a

nega

tive

sam

ples

Perc

enta

ge o

f fa

lse-p

ositi

ve P

f te

st li

nes

on

sam

ples

con

tain

ing

no

n-Pl

asm

odiu

m s

pp. i

nfec

tious

age

ntsb

Perc

enta

ge o

f fa

lse-p

ositi

ve P

f te

st li

nes

on

sam

ples

con

tain

ing

im

mun

olog

ical

fac

tors

c

Lot

1

(n=1

04)

Lot

2

(n=1

04)

Ove

rall

(n=2

08)

Lot

1

(n=3

8)Lo

t 2

(n

=38)

Ove

rall

(n=7

6)Lo

t 1

(n

=58)

Lot

2

(n=5

8)O

vera

ll (n

=116

)Pf

onl

yBI

ONOT

E M

ALAR

IA P

.f. A

g Ra

pid

Test

Kit

RG19

-11

BioN

ote,

Inc.

0.0

1.0

0.5

0.0

0.0

0.0

3.4

1.7

2.6

Care

Star

t™ M

alar

ia H

RP2/

pLDH

(Pf)

G01

81/G

0181

-ET

Acce

ss B

io, I

nc.

0.0

0.0

0.0

5.3

0.0

2.6

1.7

1.7

1.7

EzDx

™ M

alar

ia P

f Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

08Ad

vy C

hem

ical

Priv

ate

Lim

ited

1.9

0.0

1.0

2.6

7.9

5.3

3.4

3.4

3.4

Firs

t Re

spon

se®

Mal

aria

Ant

igen

P. f

alci

paru

m (H

RP2)

Ca

rd T

est

PI13

FRC

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.0.

01.

91.

00.

00.

00.

00.

00.

00.

0

Hum

asis

Mal

aria

P.f

Antig

en T

est

ANM

PF-7

025

Hum

asis

Co.

, Ltd

.1.

01.

91.

40.

05.

32.

65.

28.

66.

9

Mal

aria

Ant

igen

Tes

t-Pf

MAG

0104

0Os

car M

edic

are

Pvt.

Ltd.

1.9

0.0

1.0

2.6

0.0

1.3

0.0

1.7

0.9

One

Step

Mal

aria

P.f

Who

le b

lood

Tes

tW

37-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.0.

00.

00.

00.

00.

00.

05.

26.

96.

0

OnSi

te M

alar

ia P

f Ag

Rapi

d Te

stR0

114C

CTK

Biot

ech,

Inc.

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

Rapi

d 1-

2-3®

Hem

a® C

asse

tte

Mal

aria

PF

MAL

-PF-

CAS/

25

(100

)H

ema

Diag

nost

ic S

yste

ms

0.0

0.0

0.0

2.6

0.0

1.3

0.0

0.0

0.0

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

(HRP

II)C1

0RH

A25

Rapi

GEN

Inc.

0.0

1.0

(103

)0.

5 (2

07)

0.0

0.0

0.0

0.0

0.0

(57)

0.0

(115

)

Righ

tSig

n® M

alar

ia P

.f. R

apid

Test

Cas

sett

e (W

hole

Blo

od)

IMPF

-C51

Han

gzho

u Bi

otes

t Bio

tech

Co.

, Ltd

.0.

00.

00.

00.

00.

00.

01.

73.

42.

6

SD B

iolin

e M

alar

ia A

g P.

f (H

RP2/

pLDH

) - H

RP2

band

05FK

90St

anda

rd D

iagn

ostic

s, In

c.0.

00.

00.

00.

02.

61.

35.

26.

96.

0

SD B

iolin

e M

alar

ia A

g P.

f (H

RP2/

pLDH

) - P

f-pL

DH b

and

05FK

90St

anda

rd D

iagn

ostic

s, In

c.0.

00.

00.

00.

00.

00.

00.

00.

00.

0

Pf a

nd p

anAT

OMOR

APID

™ M

ALAR

IA (P

F/PA

N)

MM

AL01

Atom

o Di

agno

stic

s PT

Y Li

mite

d0.

00.

0 (1

03)

0.0

(207

)0.

00.

00.

06.

93.

45.

2

BION

OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kit

RG19

-08

BioN

ote,

Inc.

0.0

1.0

0.5

0.0

2.6

1.3

3.4

3.4

3.4

BioT

race

r™ M

alar

ia P

.f/PA

N R

apid

Car

d17

012

Bio

Focu

s Co

., Lt

d.0.

00.

00.

00.

02.

61.

30.

00.

00.

0

EzDx

™ M

alar

ia P

an/P

f Rap

id te

st d

etec

tion

Kit

RK M

AL 0

01Ad

vy C

hem

ical

Priv

ate

Lim

ited

1.9

1.0

1.4

0.0

2.6

1.3

0.0

1.7

0.9

Firs

t Res

pons

e® M

alar

ia A

g. p

LDH/

HRP2

Com

bo C

ard

Test

PI16

FRC

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.0.

01.

0 (1

03)

0.5

(207

)2.

60.

01.

30.

00.

00.

0

Hum

asis

Mal

aria

P.f/

Pan

Antig

en T

est

ANM

AL-7

025

Hum

asis

Co.

, Ltd

.0.

01.

00.

50.

05.

32.

63.

45.

24.

3

Is It

… M

alar

ia P

f/Pv

Dev

ice

AL03

0M

edso

urce

Ozo

ne B

iom

edic

als

1.0

0.0

(102

)0.

5 (2

06)

0.0

0.0

0.0

0.0

0.0

(57)

0.0

(115

)

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.1.

00.

00.

50.

00.

00.

00.

00.

00.

0

One

Step

Mal

aria

P.f/

Pan

Who

le B

lood

Tes

tW

62-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.0.

00.

00.

00.

00.

00.

00.

01.

70.

9

OnSi

te M

alar

ia P

f/Pa

n Ag

Rap

id T

est

R011

3CCT

K Bi

otec

h, In

c.0.

0 (1

03)

0.0

0.0

(207

)0.

02.

61.

30.

00.

00.

0

Para

scre

en®

- Ra

pid

Test

for M

alar

ia P

an/P

f50

3030

025

Zeph

yr B

iom

edic

als

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

Dia

gnos

tics,

Inc.

1.9

0.0

1.0

0.0

2.6

1.3

3.4

5.2

4.3

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pan

(HRP

II/pL

DH)

C30R

HA2

5Ra

piG

EN In

c.1.

0 (1

03)

0.0

0.5

(207

)0.

00.

00.

00.

00.

00.

0

Pf a

nd P

vAd

vanc

ed Q

ualit

y ™

One

Ste

p M

alar

ia

(Pf/

Pv) T

ri-lin

e Te

st (w

hole

blo

od)

ITP1

1003

TC4

0In

Tec

Prod

ucts

, Inc

.0.

0 (1

03)

0.0

0.0

(207

)0.

00.

00.

00.

00.

0 (5

7)0.

0 (1

15)

BioT

race

r™ M

alar

ia P

.f/P.

v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

0.0

0.0

0.0

0.0

2.6

1.3

0.0

0.0

0.0

Core

test

s® O

ne S

tep

Mal

aria

Pf/

Pv A

g Te

st D

evic

eB4

2-21

/B42

-22

Core

Tec

hnol

ogy

Co.,

Ltd.

0.0

0.0

(103

)0.

0 (2

07)

5.4

(37)

0.0

(37)

2.7

(74)

3.4

3.4

3.4

EzDx

™ M

alar

ia P

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alar

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ate

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1.9

2.9

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id T

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or M

alar

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Bio

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ne

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uct

Prod

uct

code

Man

ufac

ture

r

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enta

ge o

f fa

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ve P

f te

st li

nes

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clea

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ples

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enta

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f fa

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f te

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sam

ples

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tain

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tious

age

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enta

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f fa

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ve P

f te

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ples

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im

mun

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ical

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tors

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Lot

2

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Ove

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1

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t 2

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B® M

alar

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g P.

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v Ra

pid

Test

KH-R

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50Sh

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ai K

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Bio

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ring

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0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

Mal

aria

PV/

PF (p

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est

Inf-

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ng E

gens

Bio

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gy C

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Mer

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Step

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aria

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ech

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0.0

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0.0

0.0

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OnSi

te M

alar

ia P

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Ag

Rapi

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Quic

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Mal

aria

Pf/

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est

7105

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gnos

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0.0

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3.4

1.8

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Rapi

GEN

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CRED

IT M

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SD B

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3.4

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Pf a

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SD B

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e M

alar

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g P.

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f/P.

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anda

rd D

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00.

00.

00.

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03.

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3

SD B

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alar

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g P.

f/P.

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Pf-p

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ban

d05

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anda

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c.0.

00.

00.

00.

00.

00.

00.

00.

00.

0

NA,

not

app

licab

lePf

, Pla

smod

ium

falc

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um

Pv,

Plas

mod

ium

viv

ax

pan

, Pla

smod

ium

spp.

a

Bloo

d sa

mpl

es fr

om h

ealth

y vo

lunt

eers

with

no

know

n cu

rren

t illn

ess

or b

lood

abn

orm

ality

b Se

e Ta

ble

A4.7

for d

etai

ls

c Se

e Ta

ble

A4.8

for d

etai

ls

Tabl

e A

4.6

(con

tinue

d)


Tabl

e A

4.7:

Pha

se 2

fal

se-p

ositi

ve r

ate

for

P. fa

lcip

arum

in s

ampl

es c

onta

inin

g sp

ecifi

c no

n-m

alar

ial i

nfec

tious

pat

hoge

ns

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Perc

enta

ge o

f fa

lse p

ositi

ves

for

Plas

mod

ium

spp

. by

infe

ctio

us p

atho

gen

Deng

ueSc

hist

osom

iasis

Leish

man

iasis

Chag

as

Lot

1 (n

=12)

Lot

2 (n

=12)

Lot

1 (n

=12)

Lot

2 (n

=12)

Lot

1 (n

=10)

Lot

2 (n

=10)

Lot

1 (n

=4)

Lot

2 (n

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Pf o

nly

BION

OTE

MAL

ARIA

P.f.

Ag

Rapi

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st K

itRG

19-1

1Bi

oNot

e, In

c.0.

00.

00.

00.

00.

00.

00.

00.

0

Care

Star

t™ M

alar

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pLDH

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0181

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nc.

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0.0

16.7

0.0

0.0

0.0

0.0

0.0

EzDx

™ M

alar

ia P

f Rap

id M

alar

ia a

ntig

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test

RK M

AL 0

08Ad

vy C

hem

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Priv

ate

Lim

ited

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0.0

0.0

0.0

0.0

Firs

t Res

pons

e® M

alar

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ntig

en P

. fal

cipa

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ard

Test

PI13

FRC

Prem

ier M

edic

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orpo

ratio

n Lt

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00.

00.

00.

00.

00.

00.

00.

0

Hum

asis

Mal

aria

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en T

est

ANM

PF-7

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Hum

asis

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016

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00.

00.

00.

00.

00.

0

Mal

aria

Ant

igen

Tes

t-Pf

MAG

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car M

edic

are

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Ltd.

0.0

0.0

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0.0

0.0

0.0

0.0

0.0

One

Step

Mal

aria

P.f

Who

le b

lood

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ngzh

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otec

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00.

00.

00.

00.

00.

00.

0

OnSi

te M

alar

ia P

f Ag

Rapi

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114C

CTK

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ech,

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0.0

0.0

0.0

0.0

0.0

0.0

Rapi

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Mal

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PF

MAL

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CAS/

25 (1

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Hem

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Sys

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00.

00.

00.

00.

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0

Rapi

GEN

BIO

CRED

IT M

alar

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A25

Rapi

GEN

Inc.

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0.0

0.0

0.0

0.0

0.0

0.0

0.0

Righ

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alar

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apid

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od)

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gzho

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00.

00.

00.

00.

00.

00.

00.

0

SD B

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e M

alar

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g P.

f (H

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anda

rd D

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08.

30.

00.

00.

00.

00.

00.

0

SD B

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e M

alar

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g P.

f (H

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and

05FK

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rd D

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00.

00.

00.

00.

00.

00.

00.

0

Pf a

nd p

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APID

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MM

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stic

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mite

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00.

00.

00.

00.

00.

00.

0

BION

OTE

MAL

ARIA

P.f

& P

an A

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pid

Test

Kit

RG19

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ote,

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0.0

0.0

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0.0

0.0

0.0

0.0

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race

r™ M

alar

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N R

apid

Car

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Bio

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00.

00.

08.

30.

00.

00.

00.

0

EzDx

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f Rap

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st d

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Kit

RK M

AL 0

01Ad

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Priv

ate

Lim

ited

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0.0

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Firs

t Res

pons

e® M

alar

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CPr

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0.0

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aria

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en T

est

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00.

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00.

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0

Is It

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alar

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Dev

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0.0

0.0

0.0

0.0

0.0

0.0

0.0

Mer

iscr

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Mal

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MH

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Mer

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s Pr

ivat

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00.

00.

00.

00.

00.

00.

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0

One

Step

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aria

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Who

le B

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00.

00.

00.

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00.

00.

00.

0

OnSi

te M

alar

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f/Pa

n Ag

Rap

id T

est

R011

3CCT

K Bi

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08.

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00.

00.

00.

00.

00.

0

Para

scre

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pid

Test

for M

alar

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an/P

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3030

025

Zeph

yr B

iom

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als

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

Quic

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file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

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gnos

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0.0

0.0

0.0

0.0

0.0

0.0

0.0

25.0

Rapi

GEN

BIO

CRED

IT M

alar

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C30R

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00.

00.

00.

00.

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00.

0

Pf a

nd P

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p M

alar

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Tri-l

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who

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ITP1

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00.

00.

00.

00.

00.

00.

00.

0

BioT

race

r™ M

alar

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v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

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0.0

0.0

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0.0

0.0

0.0

0.0

Core

test

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ne S

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Mal

aria

Pf/

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g Te

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2-21

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0.0

0.0

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0.0

(11)

0.0

0.0

0.0

0.0

EzDx

™ M

alar

ia P

v/Pf

Rap

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alar

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ntig

en d

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test

RK M

AL 0

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hem

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Priv

ate

Lim

ited

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0.0

0.0

0.0

0.0

0.0

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id T

est f

or M

alar

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1002

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Bio

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0.0

0.0

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0.0

0.0

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KHB®

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Rapi

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00.

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An

ne

xes


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code

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ufac

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r

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f fa

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ositi

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for

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mod

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gen

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hist

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iasis

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man

iasis

Chag

as

Lot

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Lot

1 (n

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Lot

2 (n

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Lot

1 (n

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Lot

2 (n

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Lot

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Lot

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Mal

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PV/

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gens

Bio

tech

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0.0

0.0

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0

One

Step

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aria

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Who

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ech

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0.0

0.0

0.0

0.0

0.0

0.0

0.0

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

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112C

CTK

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0.0

0.0

0.0

0.0

0.0

0.0

0.0

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Pf/

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est

7105

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0.0

0.0

0.0

0.0

0.0

0.0

0.0

Rapi

GEN

BIO

CRED

IT M

alar

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SD B

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0.0

0.0

0.0

0.0

Pf a

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SD B

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alar

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2 ba

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anda

rd D

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00.

00.

00.

00.

00.

00.

00.

0

SD B

iolin

e M

alar

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g P.

f/P.

f/P.

v -

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anda

rd D

iagn

ostic

s, In

c.0.

00.

00.

00.

00.

00.

00.

00.

0

Pf, P

lasm

odiu

m fa

lcip

arum

P

v, Pl

asm

odiu

m v

ivax

p

an, P

lasm

odiu

m sp

ecie

s

Tabl

e A

4.7

(con

tinue

d)


Tabl

e A

4.8:

Pha

se 2

fal

se-p

ositi

ve r

ate

for

P. fa

lcip

arum

in s

ampl

es c

onta

inin

g po

tent

ially

cro

ss-r

eact

ing

bloo

d im

mun

olog

ical

fac

tors

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Perc

enta

ge o

f fa

lse p

ositi

ves

for

Plas

mod

ium

spp

. by

bloo

d im

mun

olog

ical

fac

tor

Rheu

mat

oid

fact

orAn

ti-nu

clea

r an

tibod

ies

Anti-

mou

se a

ntib

odie

sRa

pid

plas

ma

reag

in (R

PR)

posit

ive

Lot

1 (n

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Lot

2 (n

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Lot

1 (n

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Lot

2 (n

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Lot

1 (n

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Lot

2 (n

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Lot

1 (n

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2 (n

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Pf o

nly

BION

OTE

MAL

ARIA

P.f.

Ag

Rapi

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itRG

19-1

1Bi

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c.0.

00.

00.

00.

033

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00.

0

Care

Star

t™ M

alar

ia H

RP2/

pLDH

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G01

81/G

0181

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Acce

ss B

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nc.

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0.0

0.0

0.0

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16.7

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0.0

EzDx

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alar

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f Rap

id M

alar

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ntig

en d

etec

tion

test

RK M

AL 0

08Ad

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hem

ical

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ate

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ited

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0.0

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33.3

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Firs

t Res

pons

e® M

alar

ia A

ntig

en P

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cipa

rum

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ard

Test

PI13

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Prem

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edic

al C

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ratio

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00.

00.

00.

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Hum

asis

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aria

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est

ANM

PF-7

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asis

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38.

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07.

1

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aria

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aria

P.f

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otec

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316

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00.

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00.

0

OnSi

te M

alar

ia P

f Ag

Rapi

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Rapi

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PF

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IT M

alar

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apid

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hole

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IMPF

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gzho

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tech

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016

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00.

0

SD B

iolin

e M

alar

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g P.

f (H

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00.

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0

SD B

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alar

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f (H

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and

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00.

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Pf a

nd P

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™ M

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MM

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00.

0

BION

OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kit

RG19

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BioN

ote,

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0.0

0.0

0.0

0.0

33.3

33.3

0.0

0.0

BioT

race

r™ M

alar

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N R

apid

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Bio

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0

EzDx

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f Rap

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Kit

RK M

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ate

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0.0

0.0

0.0

0.0

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7.1

Firs

t Res

pons

e® M

alar

ia A

g. p

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mbo

Car

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stPI

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CPr

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pora

tion

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0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

Hum

asis

Mal

aria

P.f/

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en T

est

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asis

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00.

00.

033

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07.

1

Is It

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alar

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AL03

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0.0

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0.0

0.0

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Mer

iscr

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Pf/

Pan

Ag

MH

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Mer

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0

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Step

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aria

P.f/

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Who

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otec

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016

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00.

0

OnSi

te M

alar

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f/Pa

n Ag

Rap

id T

est

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K Bi

otec

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00.

00.

00.

00.

00.

00.

0

Para

scre

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- Ra

pid

Test

for M

alar

ia P

an/P

f50

3030

025

Zeph

yr B

iom

edic

als

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

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gnos

tics,

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0.0

0.0

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33.3

0.0

0.0

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pan

(HRP

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DH)

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0

Pf a

nd P

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vanc

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ualit

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e Ste

p M

alar

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Tri-l

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who

le bl

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1003

TC4

0In

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00.

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0 (2

5)0.

00.

00.

00.

0

BioT

race

r™ M

alar

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v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

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0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

Core

test

s® O

ne S

tep

Mal

aria

Pf/

Pv A

g Te

st D

evic

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2-21

/B42

-22

Core

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0.0

0.0

0.0

0.0

33.3

33.3

0.0

0.0

EzDx

™ M

alar

ia P

v/Pf

Rap

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alar

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ntig

en d

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test

RK M

AL 0

03Ad

vy C

hem

ical

Priv

ate

Lim

ited

0.0

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46.2

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est f

or M

alar

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1002

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phyr

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1

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t Res

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e® M

alar

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g Pf

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CPr

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r Med

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pora

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0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

Hum

asis

Mal

aria

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Antig

en T

est

ANM

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025

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asis

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, Ltd

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30.

03.

90.

033

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00.

0

An

ne

xes


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Prod

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code

Man

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r

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enta

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f fa

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for

Plas

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spp

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bloo

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mun

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fac

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Rheu

mat

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fact

orAn

ti-nu

clea

r an

tibod

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Anti-

mou

se a

ntib

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sRa

pid

plas

ma

reag

in (R

PR)

posit

ive

Lot

1 (n

=12)

Lot

2 (n

=12)

Lot

1 (n

=26)

Lot

2 (n

=26)

Lot

1 (n

=6)

Lot

2 (n

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Lot

1 (n

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Lot

2 (n

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KHB®

Mal

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Ag

P.f/

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Rapi

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7-50

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Keh

ua B

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00.

00.

00.

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00.

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0

Mal

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PV/

PF (p

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est

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gens

Bio

tech

nolo

gy C

o., L

td.

0.0

0.0

0.0

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0.0

0.0

0.0

0.0

0.0

Mer

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Mal

aria

Pf/

Pv A

gM

FLRP

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Mer

il Di

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s Pr

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00.

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00.

00.

00.

0

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Step

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aria

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Who

le B

lood

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tW

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CG

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zhou

Won

dfo

Biot

ech

Co.,

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0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

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112C

CTK

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ech,

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0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

Quic

kPro

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aria

Pf/

Pv T

est

7105

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0.0

0.0

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16.7

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BIO

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IT M

alar

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00.

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0

SD B

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0.0

Pf a

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SD B

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alar

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g P.

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f/P.

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anda

rd D

iagn

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s, In

c.0.

00.

00.

00.

033

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0

SD B

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e M

alar

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g P.

f/P.

f/P.

v -

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rd D

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s, In

c.0.

00.

00.

00.

00.

00.

00.

00.

0

Pf, P

lasm

odiu

m fa

lcip

arum

P

v, Pl

asm

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m v

ivax

p

an, P

lasm

odiu

m sp

ecie

s

Tabl

e A

4.8

(con

tinue

d)


Tabl

e A

4.9:

Pha

se 2

fal

se-p

ositi

ve r

ate

of p

an o

r P.

viv

ax t

est

line

resu

lts

on a

ll m

alar

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egat

ive

sam

ples

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Perc

enta

ge o

f fa

lse p

ositi

ve p

an t

est

lines

on

"cle

an"a

neg

ativ

e sa

mpl

esPe

rcen

tage

of

false

pos

itive

pan

tes

t lin

es o

n sa

mpl

es c

onta

inin

g no

n-Pl

asm

odiu

m s

pp. i

nfec

tious

age

ntsb

Perc

enta

ge o

f fa

lse p

ositi

ve p

an

test

line

s on

sam

ples

con

tain

ing

imm

unol

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al f

acto

rsc

Lot

1 (n

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)Lo

t 2

(n=1

04)

Ove

rall

(n=2

08)

Lot

1

(n=3

8)Lo

t 2

(n

=38)

Ove

rall

(n=7

6)Lo

t 1

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Lot

2

(n=5

8)O

vera

ll (n

=116

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onl

yBI

ONOT

E M

ALAR

IA P

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g Ra

pid

Test

Kit

RG19

-11

BioN

ote,

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NA

NA

NA

NA

NA

NA

NA

NA

NA

Care

Star

t™ M

alar

ia H

RP2/

pLDH

(Pf)

G01

81/G

0181

-ET

Acce

ss B

io, I

nc.

NA

NA

NA

NA

NA

NA

NA

NA

NA

EzDx

™ M

alar

ia P

f Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

08Ad

vy C

hem

ical

Priv

ate

Lim

ited

NA

NA

NA

NA

NA

NA

NA

NA

NA

Firs

t Res

pons

e® M

alar

ia A

ntig

en P

. fal

cipa

rum

(HRP

2) C

ard

Test

PI13

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Prem

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ratio

n Lt

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AN

AN

AN

AN

AN

AN

AN

AN

A

Hum

asis

Mal

aria

P.f

Antig

en T

est

ANM

PF-7

025

Hum

asis

Co.

, Ltd

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AN

AN

AN

AN

AN

AN

AN

AN

A

Mal

aria

Ant

igen

Tes

t-Pf

MAG

0104

0Os

car M

edic

are

Pvt.

Ltd.

NA

NA

NA

NA

NA

NA

NA

NA

NA

One

Step

Mal

aria

P.f

Who

le b

lood

Tes

tW

37-C

Gua

ngzh

ou W

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o Bi

otec

h Co

., Lt

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AN

AN

AN

AN

AN

AN

AN

AN

A

OnSi

te M

alar

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f Ag

Rapi

d Te

stR0

114C

CTK

Biot

ech,

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NA

NA

NA

NA

NA

NA

NA

NA

NA

Rapi

d 1-

2-3®

Hem

a® C

asse

tte

Mal

aria

PF

MAL

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CAS/

25 (1

00)

Hem

a Di

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Sys

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AN

AN

AN

AN

AN

AN

AN

AN

A

Rapi

GEN

BIO

CRED

IT M

alar

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g Pf

(HRP

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0RH

A25

Rapi

GEN

Inc.

NA

NA

NA

NA

NA

NA

NA

NA

NA

Righ

tSig

n® M

alar

ia P

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apid

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sett

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hole

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od)

IMPF

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Han

gzho

u Bi

otes

t Bio

tech

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, Ltd

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AN

AN

AN

AN

AN

AN

AN

AN

A

SD B

iolin

e M

alar

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g P.

f (H

RP2/

pLDH

)05

FK90

Stan

dard

Dia

gnos

tics,

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NA

NA

NA

NA

NA

NA

NA

NA

NA

Pf a

nd p

anAT

OMOR

APID

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ALAR

IA (P

F/PA

N)

MM

AL01

Atom

o Di

agno

stic

s PT

Y Li

mite

d0.

00.

0 (1

03)

0.0

(207

)0.

02.

61.

319

.017

.218

.1

BION

OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kit

RG19

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BioN

ote,

Inc.

0.0

1.0

0.5

0.0

0.0

0.0

0.0

0.0

0.0

BioT

race

r™ M

alar

ia P

.f/PA

N R

apid

Car

d17

012

Bio

Focu

s Co

., Lt

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00.

00.

00.

02.

61.

30.

00.

00.

0

EzDx

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alar

ia P

an/P

f Rap

id te

st d

etec

tion

Kit

RK M

AL 0

01Ad

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hem

ical

Priv

ate

Lim

ited

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

Firs

t Res

pons

e® M

alar

ia A

g. p

LDH

/HRP

2 Co

mbo

Car

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stPI

16FR

CPr

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pora

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1.9

1.9

(103

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9 (2

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2.6

0.0

1.3

5.2

1.7

3.5

Hum

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aria

P.f/

Pan

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en T

est

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AL-7

025

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asis

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00.

00.

00.

00.

00.

01.

70.

00.

9

Is It

… M

alar

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f/Pv

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AL03

0M

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iom

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als

0.0

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0.0

0.0

0.0

0.0

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0.0

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)

Mer

iscr

een

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Pan

Ag

MH

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Mer

il Di

agno

stic

s Pr

ivat

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d.0.

00.

00.

00.

02.

61.

30.

00.

00.

0

One

Step

Mal

aria

P.f/

Pan

Who

le B

lood

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tW

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ngzh

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o Bi

otec

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., Lt

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00.

00.

00.

00.

00.

03.

56.

95.

2

OnSi

te M

alar

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0.0

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61.

31.

70.

00.

9

Para

scre

en®

- Ra

pid

Test

for M

alar

ia P

an/P

f50

3030

025

Zeph

yr B

iom

edic

als

0.0

0.0

0.0

0.0

2.6

1.3

0.0

0.0

0.0

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

Dia

gnos

tics,

Inc.

8.7

5.8

7.2

18.4

39.5

29.0

56.9

58.6

57.8

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pan

(HRP

II/pL

DH)

C30R

HA2

5Ra

piG

EN In

c.2.

9 (1

03)

1.9

2.4

(207

)5.

32.

64.

00.

00.

00.

0

Pf a

nd P

vAd

vanc

ed Q

ualit

y™ O

ne S

tep

Mal

aria

(Pf

/Pv)

Tri-

line

Test

(w

hole

blo

od)

ITP1

1003

TC4

0In

Tec

Prod

ucts

, Inc

.0.

0 (1

03)

0.0

0.0

(207

)0.

00.

00.

00.

00.

0 (5

7)0.

0 (1

15)

BioT

race

r™ M

alar

ia P

.f/P.

v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

0.0

Core

test

s® O

ne S

tep

Mal

aria

Pf/

Pv A

g Te

st D

evic

eB4

2-21

/B42

-22

Core

Tec

hnol

ogy

Co.,

Ltd.

0.0

0.0

(103

)0.

0 (2

07)

0.0

(37)

0.0

(37)

0.0

(74)

10.3

17.2

13.8

EzDx

™ M

alar

ia P

v/Pf

Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

03Ad

vy C

hem

ical

Priv

ate

Lim

ited

1.0

2.9

1.9

0.0

0.0

0.0

0.0

17.2

8.6

Falc

iVax

™ -

Rap

id T

est f

or M

alar

ia P

v/Pf

5030

1002

5Ze

phyr

Bio

med

ical

s0.

01.

00.

50.

00.

00.

00.

00.

00.

0

Firs

t Res

pons

e® M

alar

ia A

g Pf

/Pv

Card

Tes

tPI

19FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

0.0

(103

)0.

00

(207

)0.

00.

00.

00.

00.

00.

0

Hum

asis

Mal

aria

P.f/

P.v

Antig

en T

est

ANM

IV-7

025

Hum

asis

Co.

, Ltd

.0.

0 (1

03)

1.0

0.5

(207

)0.

00.

00.

03.

53.

53.

5

An

ne

xes


Prod

uct

Prod

uct

code

Man

ufac

ture

r

Perc

enta

ge o

f fa

lse p

ositi

ve p

an t

est

lines

on

"cle

an"a

neg

ativ

e sa

mpl

esPe

rcen

tage

of

false

pos

itive

pan

tes

t lin

es o

n sa

mpl

es c

onta

inin

g no

n-Pl

asm

odiu

m s

pp. i

nfec

tious

age

ntsb

Perc

enta

ge o

f fa

lse p

ositi

ve p

an

test

line

s on

sam

ples

con

tain

ing

imm

unol

ogic

al f

acto

rsc

Lot

1 (n

=104

)Lo

t 2

(n=1

04)

Ove

rall

(n=2

08)

Lot

1

(n=3

8)Lo

t 2

(n

=38)

Ove

rall

(n=7

6)Lo

t 1

(n

=58)

Lot

2

(n=5

8)O

vera

ll (n

=116

)KH

B® M

alar

ia A

g P.

f/P.

v Ra

pid

Test

KH-R

-07-

50Sh

angh

ai K

ehua

Bio

-eng

inee

ring

Co.,

Ltd.

0.0

0.0

0.0

0.0

0.0

0.0

5.2

3.5

4.3

Mal

aria

PV/

PF (p

LDH

/HRP

2) A

ntig

en T

est

Inf-

72N

anto

ng E

gens

Bio

tech

nolo

gy C

o., L

td.

0.0

(103

)0.

0 (1

00)

0.0

(203

)0.

00.

00.

00.

0 (5

7)0.

00.

0 (1

15)

Mer

iscr

een

Mal

aria

Pf/

Pv A

gM

FLRP

D-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.0.

00.

00.

00.

00.

00.

00.

00.

00.

0

One

Step

Mal

aria

P.f/

P.v

Who

le B

lood

Tes

tW

056-

CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

0.0

0.0

0.0

0.0

0.0

0.0

5.2

6.9

6.0

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

d Te

stR0

112C

CTK

Biot

ech,

Inc.

0.0

0.0

(103

)0.

0 (2

07)

0.0

0.0

(37)

0.0

(75)

0.0

0.0

0.0

Quic

kPro

file™

Mal

aria

Pf/

Pv T

est

7105

0Lu

miq

uick

Dia

gnos

tics,

Inc.

0.0

0.0

0.0

5.3

0.0

2.6

12.1

1.8

(57)

7.0

(115

)

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pv

(HRP

II/pL

DH)

C40R

HA2

5Ra

piG

EN In

c.3.

94.

9 (1

03)

4.4

(207

)0.

00.

00.

00.

00.

0 (5

7)0.

0 (1

15)

SD B

iolin

e M

alar

ia A

g P.

f/P.

v05

FK80

Stan

dard

Dia

gnos

tics,

Inc.

2.9

1.0

1.9

0.0

0.0

0.0

0.0

0.0

0.0

Pf a

nd P

f an

d Pv

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.0.

00.

00.

00.

00.

00.

00.

00.

00.

0

NA,

not

app

licab

lePf

, Pla

smod

ium

falc

ipar

um

Pv,

Plas

mod

ium

viv

ax

pan

, Pla

smod

ium

spec

ies

a

Bloo

d sa

mpl

es fr

om h

ealth

y vo

lunt

eers

with

no

know

n cu

rren

t illn

ess

or b

lood

abn

orm

ality

b Se

e Ta

ble

A4.7

for d

etai

ls

c Se

e Ta

ble

A4.8

for d

etai

ls

Tabl

e A

4.9

(con

tinue

d)


Tabl

e A

4.10

: Hea

t st

abili

ty t

estin

g re

sult

s fo

r P.

falc

ipar

um t

est

line

on a

P. f

alci

paru

m s

ampl

e at

low

par

asit

e de

nsit

y (2

00 p

aras

ites

/µL)

. Po

siti

vity

rat

e at

bas

elin

e (r

oom

tem

pera

ture

) an

d af

ter

60 d

ays’

incu

batio

n at

roo

m t

empe

ratu

re, 3

5°C

and

45°C

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Base

line

test

ing

35 °C

45 °C

Room

tem

pera

ture

Lot

1 (n

=15)

Lot

2 (n

=15)

Lot

1 (n

=15)

Lot

2 (n

=15)

Lot

1 (n

=15)

Lot

2 (n

=15)

Lot

1 (n

=15)

Lot

2 (n

=15)

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

Pf o

nly

BION

OTE

MAL

ARIA

P.f.

Ag

Rapi

d Te

st K

itRG

19-1

1Bi

oNot

e, In

c.15

03.

115

03.

015

03.

015

03.

015

03.

015

03.

015

02.

515

02.

9

Care

Star

t™ M

alar

ia H

RP2/

pLDH

(Pf)

G01

81/G

0181

-ET

Acce

ss B

io, I

nc.

150

3.2

150

3.0

141

3.0

150

3.0

150

3.0

150

3.0

150

3.0

150

2.9

EzDx

™ M

alar

ia P

f Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

08Ad

vy C

hem

ical

Priv

ate

Lim

ited

150

2.0

150

2.0

150

2.0

150

2.0

150

2.0

150

1.7

150

1.9

150

2.0

Firs

t Res

pons

e® M

alar

ia A

ntig

en P

. fal

cipa

rum

(HRP

2) C

ard

Test

PI13

FRC

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.15

03.

415

02.

915

03.

015

03.

015

03.

215

03.

015

02.

915

02.

9

Hum

asis

Mal

aria

P.f

Antig

en T

est

ANM

PF-7

025

Hum

asis

Co.

, Ltd

.15

02.

015

02.

015

02.

915

03.

015

02.

015

02.

015

02.

015

03.

0

Mal

aria

Ant

igen

Tes

t-Pf

MAG

0104

0Os

car M

edic

are

Pvt.

Ltd.

150

3.0

150

3.3

150

3.7

150

2.9

150

3.1

150

3.0

150

2.7

150

3.1

One

Step

Mal

aria

P.f

Who

le b

lood

Tes

tW

37-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.15

01.

915

02.

013

02.

515

02.

815

02.

015

02.

915

02.

015

02.

9

OnSi

te M

alar

ia P

f Ag

Rapi

d Te

stR0

114C

CTK

Biot

ech,

Inc.

150

2.1

150

2.6

150

2.0

150

2.5

150

2.2

150

2.3

150

2.0

150

2.0

Rapi

d 1-

2-3®

Hem

a® C

asse

tte

Mal

aria

PF

MAL

-PF-

CAS/

25 (1

00)

Hem

a Di

agno

stic

Sys

tem

s15

03.

015

03.

015

03.

015

03.

015

02.

915

03.

015

03.

015

03.

0

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

(HRP

II)C1

0RH

A25

Rapi

GEN

Inc.

150

3.0

150

3.0

150

3.0

150

3.0

150

3.0

150

3.0

150

3.0

150

3.0

Righ

tSig

n® M

alar

ia P

.f. R

apid

Tes

t Cas

sett

e (W

hole

Blo

od)

IMPF

-C51

Han

gzho

u Bi

otes

t Bio

tech

Co.

, Ltd

.15

02.

015

02.

015

02.

015

02.

715

02.

015

02.

015

02.

015

02.

0

SD B

iolin

e M

alar

ia A

g P.

f (H

RP2/

pLDH

) - H

RP2

band

05FK

90St

anda

rd D

iagn

ostic

s, In

c.15

03.

015

03.

015

03.

315

03.

015

03.

015

03.

015

03.

915

03.

0

SD B

iolin

e M

alar

ia A

g P.

f (H

RP2/

pLDH

) - P

f-pL

DH b

and

05FK

90St

anda

rd D

iagn

ostic

s, In

c.13

01.

015

01.

015

01.

012

01.

011

01.

09

01.

015

01.

013

01.

0

Pf a

nd p

anAT

OMOR

APID

™ M

ALAR

IA (P

F/PA

N)

MM

AL01

Atom

o Di

agno

stic

s PT

Y Li

mite

d15

03.

015

02.

915

02.

915

03.

014

12.

915

03.

015

02.

915

03.

0

BION

OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kit

RG19

-08

BioN

ote,

Inc.

150

3.0

150

3.0

150

3.0

150

2.8

150

2.7

150

3.0

150

3.0

150

3.0

BioT

race

r™ M

alar

ia P

.f/PA

N R

apid

Car

d17

012

Bio

Focu

s Co

., Lt

d.15

03.

015

02.

915

03.

015

03.

015

02.

915

02.

915

03.

015

03.

0

EzDx

™ M

alar

ia P

an/P

f Rap

id te

st d

etec

tion

Kit

RK M

AL 0

01Ad

vy C

hem

ical

Priv

ate

Lim

ited

150

2.0

150

2.1

150

2.0

150

2.5

150

2.0

150

2.7

150

2.7

150

3.0

Firs

t Res

pons

e® M

alar

ia A

g. p

LDH

/HRP

2 Co

mbo

Car

d Te

stPI

16FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

150

3.0

150

2.9

150

3.0

150

2.9

150

2.6

150

2.9

150

3.0

150

3.0

Hum

asis

Mal

aria

P.f/

Pan

Antig

en T

est

ANM

AL-7

025

Hum

asis

Co.

, Ltd

.15

02.

015

02.

015

02.

915

02.

915

02.

015

02.

215

02.

315

03.

0

Is It

… M

alar

ia P

f/Pv

Dev

ice

AL03

0M

edso

urce

Ozo

ne B

iom

edic

als

150

3.1

141

3.0

150

3.0

141

3.1

150

3.1

140

3.0

150

2.9

150

3.0

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.15

02.

015

02.

015

02.

015

02.

015

02.

015

02.

315

02.

015

02.

1

One

Step

Mal

aria

P.f/

Pan

Who

le B

lood

Tes

tW

62-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.15

01.

815

01.

915

02.

115

02.

415

02.

014

02.

015

02.

115

02.

7

OnSi

te M

alar

ia P

f/Pa

n Ag

Rap

id T

est

R011

3CCT

K Bi

otec

h, In

c.15

02.

015

02.

915

02.

015

02.

515

02.

115

02.

415

02.

215

02.

1

Para

scre

en®

- Ra

pid

Test

for M

alar

ia P

an/P

f50

3030

025

Zeph

yr B

iom

edic

als

150

3.0

150

2.1

150

3.0

150

3.0

150

2.3

150

2.9

150

3.0

150

2.9

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

Dia

gnos

tics,

Inc.

150

2.0

150

2.0

150

3.0

150

2.7

150

2.0

150

2.3

150

2.1

150

2.3

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pan

(HRP

II/pL

DH)

C30R

HA2

5Ra

piG

EN In

c.15

03.

015

03.

015

03.

015

03.

014

03.

115

03.

015

03.

015

03.

0

Pf a

nd P

vAd

vanc

ed Q

ualit

y™ O

ne St

ep M

alaria

(Pf/P

v) Tr

i-lin

e Tes

t (w

hole

bloo

d)IT

P110

03 T

C40

InTe

c Pr

oduc

ts, I

nc.

140

2.0

150

2.7

150

2.3

150

2.5

150

1.9

150

2.1

150

2.4

150

2.1

BioT

race

r™ M

alar

ia P

.f/P.

v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

150

3.0

150

3.0

150

2.9

150

3.0

150

3.0

150

3.0

150

3.0

150

2.9

Core

test

s® O

ne S

tep

Mal

aria

Pf/

Pv A

g Te

st D

evic

eB4

2-21

/B42

-22

Core

Tec

hnol

ogy

Co.,

Ltd.

150

2.0

150

2.0

150

2.0

150

2.5

150

2.0

150

2.3

150

2.0

150

2.6

EzDx

™ M

alar

ia P

v/Pf

Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

03Ad

vy C

hem

ical

Priv

ate

Lim

ited

150

2.0

150

2.0

150

2.0

150

2.1

150

2.0

150

2.7

150

2.9

150

2.9

Falc

iVax

™ -

Rap

id T

est f

or M

alar

ia P

v/Pf

5030

1002

5Ze

phyr

Bio

med

ical

s15

03.

015

03.

015

03.

014

13.

015

03.

015

03.

015

03.

015

03.

0

Firs

t Res

pons

e® M

alar

ia A

g Pf

/Pv

Card

Tes

tPI

19FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

150

3.0

150

2.9

150

3.0

150

2.9

150

3.0

141

3.0

150

2.9

150

3.0

Hum

asis

Mal

aria

P.f/

P.v

Antig

en T

est

ANM

IV-7

025

Hum

asis

Co.

, Ltd

.15

02.

015

02.

015

03.

015

02.

915

02.

015

02.

015

02.

015

03.

0

KHB®

Mal

aria

Ag

P.f/

P.v

Rapi

d Te

stKH

-R-0

7-50

Shan

ghai

Keh

ua B

io-e

ngin

eerin

g Co

., Lt

d.15

02.

715

03.

015

03.

015

03.

215

03.

015

03.

015

03.

115

03.

0

Mal

aria

PV/

PF (p

LDH

/HRP

2) A

ntig

en T

est

Inf-

72N

anto

ng E

gens

Bio

tech

nolo

gy C

o., L

td.

150

2.9

150

3.0

150

3.0

150

3.0

150

2.9

131

3.0

150

3.0

141

3.0

An

ne

xes


Prod

uct

Prod

uct

code

Man

ufac

ture

r

Base

line

test

ing

35 °C

45 °C

Room

tem

pera

ture

Lot

1 (n

=15)

Lot

2 (n

=15)

Lot

1 (n

=15)

Lot

2 (n

=15)

Lot

1 (n

=15)

Lot

2 (n

=15)

Lot

1 (n

=15)

Lot

2 (n

=15)

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

Mer

iscr

een

Mal

aria

Pf/

Pv A

gM

FLRP

D-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.15

02.

015

02.

015

02.

115

02.

015

02.

015

02.

315

02.

015

02.

1

One

Step

Mal

aria

P.f/

P.v

Who

le B

lood

Tes

tW

056-

CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

150

1.9

150

2.0

150

2.1

150

2.5

150

1.7

150

2.0

150

2.1

150

2.7

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

d Te

stR0

112C

CTK

Biot

ech,

Inc.

150

2.0

150

2.5

150

2.1

150

2.6

150

2.1

150

2.1

150

2.1

150

2.0

Quic

kPro

file™

Mal

aria

Pf/

Pv T

est

7105

0Lu

miq

uick

Dia

gnos

tics,

Inc.

150

2.0

150

2.0

150

3.0

150

2.8

150

1.9

150

1.9

150

2.1

150

2.4

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pv

(HRP

II/pL

DH)

C40R

HA2

5Ra

piG

EN In

c.15

03.

014

13.

015

02.

915

03.

015

03.

015

03.

015

03.

015

03.

0

SD B

iolin

e M

alar

ia A

g P.

f/P.

v05

FK80

Stan

dard

Dia

gnos

tics,

Inc.

150

2.8

150

3.0

150

3.0

150

3.0

141

3.0

150

3.0

150

3.0

150

3.0

Pf a

nd P

f an

d Pv

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v -

HRP

2 ba

nd05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.15

03.

015

03.

015

03.

015

03.

015

03.

015

03.

015

03.

115

02.

9

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v -

Pf-p

LDH

ban

d05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.0

0N

D9

01.

09

01.

00

0N

D0

0N

D9

01.

014

01.

09

01.

0

ND,

not

det

erm

ined

Pf, P

lasm

odiu

m fa

lcip

arum

P

v, Pl

asm

odiu

m v

ivax

p

an, P

lasm

odiu

m sp

ecie

s

Tabl

e A

4.10

a: H

eat

stab

ility

tes

ting

resu

lts

for

pan

test

line

of

com

bina

tion

RDTs

on

a P.

falc

ipar

um s

ampl

e at

low

par

asit

e de

nsit

y (2

00 p

aras

ites

/µL)

. Po

siti

vity

rat

e at

bas

elin

e (r

oom

tem

pera

ture

) an

d af

ter

60 d

ays’

incu

batio

n at

roo

m t

empe

ratu

re, 3

5°C

and

45°C

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Base

line

test

ing

35 °C

45 °C

Room

tem

pera

ture

Lot

1 (n

=15)

Lot

2 (n

=15)

Lot

1 (n

=15)

Lot

2 (n

=15)

Lot

1 (n

=15)

Lot

2 (n

=15)

Lot

1 (n

=15)

Lot

2 (n

=15)

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

Pf a

nd P

anAT

OMOR

APID

™ M

ALAR

IA (P

F/PA

N)

MM

AL01

Atom

o Di

agno

stic

s PT

Y Li

mite

d0

0N

D0

0N

D0

0N

D5

01.

00

1N

D0

0N

D0

0N

D0

0N

D

BION

OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kit

RG19

-08

BioN

ote,

Inc.

00

ND

00

ND

00

ND

00

ND

00

ND

00

ND

00

ND

00

ND

BioT

race

r™ M

alar

ia P

.f/PA

N R

apid

Car

d17

012

Bio

Focu

s Co

., Lt

d.15

01.

015

01.

013

01.

015

01.

015

01.

15

01.

015

01.

012

01.

0

EzDx

™ M

alar

ia P

an/P

f Rap

id te

st d

etec

tion

Kit

RK M

AL 0

01Ad

vy C

hem

ical

Priv

ate

Lim

ited

00

ND

10

1.0

70

1.0

00

ND

00

ND

30

1.0

60

1.0

30

1.0

Firs

t Res

pons

e® M

alar

ia A

g. p

LDH

/HRP

2 Co

mbo

Car

d Te

stPI

16FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

150

1.0

140

1.0

150

1.0

150

1.0

100

1.0

110

1.0

120

1.0

150

1.0

Hum

asis

Mal

aria

P.f/

Pan

Antig

en T

est

ANM

AL-7

025

Hum

asis

Co.

, Ltd

.0

0N

D0

0N

D0

0N

D0

0N

D0

0N

D0

0N

D0

0N

D0

0N

D

Is It

… M

alar

ia P

f/Pv

Dev

ice

AL03

0M

edso

urce

Ozo

ne B

iom

edic

als

150

1.0

121

1.0

140

1.0

141

1.0

110

1.0

00

ND

80

1.0

120

1.0

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.10

01.

04

01.

08

01.

09

01.

00

0N

D0

0N

D13

01.

011

01.

0

One

Step

Mal

aria

P.f/

Pan

Who

le B

lood

Tes

tW

62-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.0

0N

D0

0N

D0

0N

D0

0N

D0

0N

D0

0N

D0

0N

D0

0N

D

OnSi

te M

alar

ia P

f/Pa

n Ag

Rap

id T

est

R011

3CCT

K Bi

otec

h, In

c.0

0N

D0

0N

D2

01.

00

0N

D0

0N

D0

0N

D0

0N

D0

0N

D

Para

scre

en®

- Ra

pid

Test

for M

alar

ia P

an/P

f50

3030

025

Zeph

yr B

iom

edic

als

150

1.0

150

1.0

120

1.0

150

1.0

150

1.0

130

1.0

120

1.0

150

1.0

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

Dia

gnos

tics,

Inc.

150

1.0

150

1.0

150

1.0

140

1.0

150

1.0

150

1.0

140

1.0

150

1.0

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pan

(HRP

II/pL

DH)

C30R

HA2

5Ra

piG

EN In

c.0

0N

D0

0N

D3

01.

00

0N

D3

01.

05

01.

00

0N

D1

01.

0

ND,

not

det

erm

ined

Pf, P

lasm

odiu

m fa

lcip

arum

P

v, Pl

asm

odiu

m v

ivax

p

an, P

lasm

odiu

m sp

ecie

s

Tabl

e A

4.10

(con

tinue

d)


Tabl

e A

4.11

: Hea

t st

abili

ty t

estin

g re

sult

s fo

r P.

falc

ipar

um t

est

line

on a

P. f

alci

paru

m s

ampl

e at

hig

h pa

rasi

te d

ensi

ty (2

000

para

site

s/µL

).

Posi

tivi

ty r

ate

at b

asel

ine

(roo

m t

empe

ratu

re)

and

afte

r 60

day

s’ in

cuba

tion

at r

oom

tem

pera

ture

, 35°

C an

d 45

°C

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Base

line

test

ing

35 °C

45 °C

Room

tem

pera

ture

Lot

1 (n

=5)

Lot

2 (n

=5)

Lot

1 (n

=5)

Lot

2 (n

=5)

Lot

1 (n

=5)

Lot

2 (n

=5)

Lot

1 (n

=5)

Lot

2 (n

=5)

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

Pf o

nly

BION

OTE

MAL

ARIA

P.f.

Ag

Rapi

d Te

st K

itRG

19-1

1Bi

oNot

e, In

c.5

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

0

Care

Star

t™ M

alar

ia H

RP2/

pLDH

(Pf)

G01

81/G

0181

-ET

Acce

ss B

io, I

nc.

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

EzDx

™ M

alar

ia P

f Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

08Ad

vy C

hem

ical

Priv

ate

Lim

ited

50

3.0

50

3.0

50

4.0

50

3.8

50

3.0

50

4.0

50

4.0

50

4.0

Firs

t Res

pons

e® M

alar

ia A

ntig

en P

. fal

cipa

rum

(HRP

2) C

ard

Test

PI13

FRC

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.5

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

0

Hum

asis

Mal

aria

P.f

Antig

en T

est

ANM

PF-7

025

Hum

asis

Co.

, Ltd

.5

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

0

Mal

aria

Ant

igen

Tes

t-Pf

MAG

0104

0Os

car M

edic

are

Pvt.

Ltd.

50

4.0

50

4.0

50

4.0

50

3.8

50

4.0

50

4.0

50

4.0

50

4.0

One

Step

Mal

aria

P.f

Who

le b

lood

Tes

tW

37-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.5

04.

05

04.

05

04.

05

04.

05

03.

85

04.

05

03.

85

04.

0

OnSi

te M

alar

ia P

f Ag

Rapi

d Te

stR0

114C

CTK

Biot

ech,

Inc.

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

3.8

50

3.8

50

4.0

Rapi

d 1-

2-3®

Hem

a® C

asse

tte

Mal

aria

PF

MAL

-PF-

CAS/

25 (1

00)

Hem

a Di

agno

stic

Sys

tem

s5

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

0

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

(HRP

II)C1

0RH

A25

Rapi

GEN

Inc.

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

Righ

tSig

n® M

alar

ia P

.f. R

apid

Tes

t Cas

sett

e (W

hole

Blo

od)

IMPF

-C51

Han

gzho

u Bi

otes

t Bio

tech

Co.

, Ltd

.5

02.

65

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

0

SD B

iolin

e M

alar

ia A

g P.

f (H

RP2/

pLDH

) - H

RP2

band

05FK

90St

anda

rd D

iagn

ostic

s, In

c.5

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

0

SD B

iolin

e M

alar

ia A

g P.

f (H

RP2/

pLDH

) - P

f-pL

DH b

and

05FK

90St

anda

rd D

iagn

ostic

s, In

c.5

02.

05

02.

05

02.

05

02.

05

02.

05

02.

05

02.

05

02.

0

Pf a

nd P

anAT

OMOR

APID

™ M

ALAR

IA (P

F/PA

N)

MM

AL01

Atom

o Di

agno

stic

s PT

Y Li

mite

d5

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

0

BION

OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kit

RG19

-08

BioN

ote,

Inc.

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

BioT

race

r™ M

alar

ia P

.f/PA

N R

apid

Car

d17

012

Bio

Focu

s Co

., Lt

d.5

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

0

EzDx

™ M

alar

ia P

an/P

f Rap

id te

st d

etec

tion

Kit

RK M

AL 0

01Ad

vy C

hem

ical

Priv

ate

Lim

ited

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

3.8

50

4.0

Firs

t Res

pons

e® M

alar

ia A

g. p

LDH

/HRP

2 Co

mbo

Car

d Te

stPI

16FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

Hum

asis

Mal

aria

P.f/

Pan

Antig

en T

est

ANM

AL-7

025

Hum

asis

Co.

, Ltd

.5

03.

85

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

0

Is It

… M

alar

ia P

f/Pv

Dev

ice

AL03

0M

edso

urce

Ozo

ne B

iom

edic

als

50

4.0

41

4.0

50

4.0

50

4.0

50

4.0

50

3.8

50

4.0

50

4.0

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.5

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

0

One

Step

Mal

aria

P.f/

Pan

Who

le B

lood

Tes

tW

62-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.5

03.

85

04.

05

03.

85

04.

05

03.

65

03.

45

04.

05

04.

0

OnSi

te M

alar

ia P

f/Pa

n Ag

Rap

id T

est

R011

3CCT

K Bi

otec

h, In

c.5

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

03.

8

Para

scre

en®

- Ra

pid

Test

for M

alar

ia P

an/P

f50

3030

025

Zeph

yr B

iom

edic

als

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

Dia

gnos

tics,

Inc.

50

4.0

50

4.0

50

4.0

50

4.0

50

3.8

50

4.0

50

4.0

50

4.0

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pan

(HRP

II/pL

DH)

C30R

HA2

5Ra

piG

EN In

c.5

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

0

Pf a

nd P

vAd

vanc

ed Q

ualit

y™ O

ne St

ep M

alaria

(Pf/P

v) Tr

i-lin

e Tes

t (w

hole

bloo

d)IT

P110

03 T

C40

InTe

c Pr

oduc

ts, I

nc.

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

BioT

race

r™ M

alar

ia P

.f/P.

v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

Core

test

s® O

ne S

tep

Mal

aria

Pf/

Pv A

g Te

st D

evic

eB4

2-21

/B42

-22

Core

Tec

hnol

ogy

Co.,

Ltd.

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

EzDx

™ M

alar

ia P

v/Pf

Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

03Ad

vy C

hem

ical

Priv

ate

Lim

ited

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

Falc

iVax

™ -

Rap

id T

est f

or M

alar

ia P

v/Pf

5030

1002

5Ze

phyr

Bio

med

ical

s5

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

0

Firs

t Res

pons

e® M

alar

ia A

g Pf

/Pv

Card

Tes

tPI

19FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

41

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

Hum

asis

Mal

aria

P.f/

P.v

Antig

en T

est

ANM

IV-7

025

Hum

asis

Co.

, Ltd

.5

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

0

KHB®

Mal

aria

Ag

P.f/

P.v

Rapi

d Te

stKH

-R-0

7-50

Shan

ghai

Keh

ua B

io-e

ngin

eerin

g Co

., Lt

d.5

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

0

An

ne

xes


Prod

uct

Prod

uct

code

Man

ufac

ture

r

Base

line

test

ing

35 °C

45 °C

Room

tem

pera

ture

Lot

1 (n

=5)

Lot

2 (n

=5)

Lot

1 (n

=5)

Lot

2 (n

=5)

Lot

1 (n

=5)

Lot

2 (n

=5)

Lot

1 (n

=5)

Lot

2 (n

=5)

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

Mal

aria

PV/

PF (p

LDH

/HRP

2) A

ntig

en T

est

Inf-

72N

anto

ng E

gens

Bio

tech

nolo

gy C

o., L

td.

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

Mer

iscr

een

Mal

aria

Pf/

Pv A

gM

FLRP

D-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.5

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

0

One

Step

Mal

aria

P.f/

P.v

Who

le B

lood

Tes

tW

056-

CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

50

4.0

50

4.0

50

4.0

50

4.0

50

3.2

50

4.0

50

4.0

50

4.0

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

d Te

stR0

112C

CTK

Biot

ech,

Inc.

50

4.0

41

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

Quic

kPro

file™

Mal

aria

Pf/

Pv T

est

7105

0Lu

miq

uick

Dia

gnos

tics,

Inc.

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

3.8

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pv

(HRP

II/pL

DH)

C40R

HA2

5Ra

piG

EN In

c.5

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

0

SD B

iolin

e M

alar

ia A

g P.

f/P.

v05

FK80

Stan

dard

Dia

gnos

tics,

Inc.

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

50

4.0

Pf a

nd P

f an

d Pv

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v -

HRP

2 ba

nd05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.5

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

05

04.

0

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v -

Pf-p

LDH

ban

d05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.5

01.

85

02.

05

02.

05

02.

05

02.

05

02.

05

02.

05

02.

0

Pf, P

lasm

odiu

m fa

lcip

arum

P

v, Pl

asm

odiu

m v

ivax

p

an, P

lasm

odiu

m sp

ecie

s

Tabl

e A

4.11

a: H

eat

stab

ility

tes

ting

resu

lts

for

pan

test

line

of

com

bina

tion

RDTs

on

a P.

falc

ipar

um s

ampl

e at

hig

h pa

rasi

te d

ensi

ty (2

000

para

site

s/µL

).

Posi

tivi

ty r

ate

at b

asel

ine

(roo

m t

empe

ratu

re)

and

afte

r 60

day

s’ in

cuba

tion

at r

oom

tem

pera

ture

, 35°

C an

d 45

°C

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Base

line

test

ing

35 °C

45 °C

Room

tem

pera

ture

Lot

1 (n

=5)

Lot

2 (n

=5)

Lot

1 (n

=5)

Lot

2 (n

=5)

Lot

1 (n

=5)

Lot

2 (n

=5)

Lot

1 (n

=5)

Lot

2 (n

=5)

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

Pf a

nd P

anAT

OMOR

APID

™ M

ALAR

IA (P

F/PA

N)

MM

AL01

Atom

o Di

agno

stic

s PT

Y Li

mite

d5

01.

05

01.

05

02.

05

01.

25

01.

05

02.

05

01.

05

02.

0

BION

OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kit

RG19

-08

BioN

ote,

Inc.

50

2.0

50

2.0

50

2.0

50

2.0

50

2.0

50

2.0

50

1.8

50

2.0

BioT

race

r™ M

alar

ia P

.f/PA

N R

apid

Car

d17

012

Bio

Focu

s Co

., Lt

d.5

02.

65

02.

05

02.

05

02.

05

02.

05

02.

05

02.

05

02.

0

EzDx

™ M

alar

ia P

an/P

f Rap

id te

st d

etec

tion

Kit

RK M

AL 0

01Ad

vy C

hem

ical

Priv

ate

Lim

ited

50

2.0

50

2.0

50

2.0

50

2.0

50

2.0

50

2.0

50

1.8

50

2.0

Firs

t Res

pons

e® M

alar

ia A

g. p

LDH

/HRP

2 Co

mbo

Car

d Te

stPI

16FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

50

2.0

50

2.2

50

2.0

50

2.0

50

2.0

50

2.0

50

2.2

50

2.0

Hum

asis

Mal

aria

P.f/

Pan

Antig

en T

est

ANM

AL-7

025

Hum

asis

Co.

, Ltd

.5

01.

05

01.

05

02.

05

01.

05

01.

05

01.

45

01.

05

01.

0

Is It

… M

alar

ia P

f/Pv

Dev

ice

AL03

0M

edso

urce

Ozo

ne B

iom

edic

als

50

2.0

41

2.0

50

2.0

50

2.0

50

1.8

40

2.0

50

2.0

50

2.0

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.5

01.

85

01.

85

02.

05

01.

85

02.

05

02.

05

02.

05

02.

2

One

Step

Mal

aria

P.f/

Pan

Who

le B

lood

Tes

tW

62-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.4

01.

05

01.

05

01.

05

01.

03

01.

04

01.

05

01.

05

01.

0

OnSi

te M

alar

ia P

f/Pa

n Ag

Rap

id T

est

R011

3CCT

K Bi

otec

h, In

c.5

01.

85

02.

05

02.

05

02.

05

02.

05

01.

85

02.

05

02.

0

Para

scre

en®

- Ra

pid

Test

for M

alar

ia P

an/P

f50

3030

025

Zeph

yr B

iom

edic

als

50

2.0

50

2.0

50

2.0

50

2.6

50

2.0

50

2.0

50

2.0

50

2.0

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

Dia

gnos

tics,

Inc.

50

2.0

50

2.0

50

2.0

50

2.0

50

2.0

50

2.0

50

1.6

50

2.0

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pan

(HRP

II/pL

DH)

C30R

HA2

5Ra

piG

EN In

c.5

02.

05

02.

05

02.

05

02.

05

02.

05

02.

05

02.

05

01.

8

Pf, P

lasm

odiu

m fa

lcip

arum

P

v, Pl

asm

odiu

m v

ivax

p

an, P

lasm

odiu

m sp

ecie

s

Tabl

e A

4.11

(con

tinue

d)


Tabl

e A

4.12

: Hea

t st

abili

ty t

estin

g re

sult

s fo

r P.

falc

ipar

um t

est

line

on p

aras

ite-

nega

tive

sam

ples

. Po

siti

vity

rat

e at

bas

elin

e (r

oom

tem

pera

ture

) an

d af

ter

60 d

ays’

incu

batio

n at

roo

m t

empe

ratu

re, 3

5°C

and

45°C

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Base

line

test

ing

35 °C

45 °C

Room

tem

pera

ture

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

Pf o

nly

BION

OTE

MAL

ARIA

P.f.

Ag

Rapi

d Te

st K

itRG

19-1

1Bi

oNot

e, In

c.0

00

00

00

00

00

00

00

0

Care

Star

t™ M

alar

ia H

RP2/

pLDH

(Pf)

G01

81/G

0181

-ET

Acce

ss B

io, I

nc.

00

00

00

00

00

00

00

00

EzDx

™ M

alar

ia P

f Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

08Ad

vy C

hem

ical

Priv

ate

Lim

ited

00

00

00

00

00

00

00

00

Firs

t Res

pons

e® M

alar

ia A

ntig

en P

. fal

cipa

rum

(HRP

2) C

ard

Test

PI13

FRC

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.0

00

00

00

00

00

00

00

0

Hum

asis

Mal

aria

P.f

Antig

en T

est

ANM

PF-7

025

Hum

asis

Co.

, Ltd

.0

00

00

00

00

00

02

00

0

Mal

aria

Ant

igen

Tes

t-Pf

MAG

0104

0Os

car M

edic

are

Pvt.

Ltd.

00

00

00

00

00

00

00

00

One

Step

Mal

aria

P.f

Who

le b

lood

Tes

tW

37-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.0

00

00

00

00

00

00

00

0

OnSi

te M

alar

ia P

f Ag

Rapi

d Te

stR0

114C

CTK

Biot

ech,

Inc.

00

00

00

00

00

00

00

00

Rapi

d 1-

2-3®

Hem

a® C

asse

tte

Mal

aria

PF

MAL

-PF-

CAS/

25 (1

00)

Hem

a Di

agno

stic

Sys

tem

s0

00

00

00

00

00

00

00

0

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

(HRP

II)C1

0RH

A25

Rapi

GEN

Inc.

00

00

00

00

00

00

00

00

Righ

tSig

n® M

alar

ia P

.f. R

apid

Tes

t Cas

sett

e (W

hole

Blo

od)

IMPF

-C51

Han

gzho

u Bi

otes

t Bio

tech

Co.

, Ltd

.0

00

00

00

00

00

00

00

0

SD B

iolin

e M

alar

ia A

g P.

f (H

RP2/

pLDH

) - H

RP2

band

05FK

90St

anda

rd D

iagn

ostic

s, In

c.0

00

00

00

00

00

00

00

0

SD B

iolin

e M

alar

ia A

g P.

f (H

RP2/

pLDH

) - P

f-pL

DH b

and

05FK

90St

anda

rd D

iagn

ostic

s, In

c.0

00

00

00

00

00

00

00

0

Pf a

nd P

anAT

OMOR

APID

™ M

ALAR

IA (P

F/PA

N)

MM

AL01

Atom

o Di

agno

stic

s PT

Y Li

mite

d0

00

02

00

00

11

03

00

0

BION

OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kit

RG19

-08

BioN

ote,

Inc.

00

00

00

00

00

00

00

00

BioT

race

r™ M

alar

ia P

.f/PA

N R

apid

Car

d17

012

Bio

Focu

s Co

., Lt

d.0

00

00

00

00

00

00

00

0

EzDx

™ M

alar

ia P

an/P

f Rap

id te

st d

etec

tion

Kit

RK M

AL 0

01Ad

vy C

hem

ical

Priv

ate

Lim

ited

00

00

00

00

00

00

00

00

Firs

t Res

pons

e® M

alar

ia A

g. p

LDH

/HRP

2 Co

mbo

Car

d Te

stPI

16FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

00

00

00

00

00

00

00

00

Hum

asis

Mal

aria

P.f/

Pan

Antig

en T

est

ANM

AL-7

025

Hum

asis

Co.

, Ltd

.0

00

02

00

00

00

00

00

0

Is It

… M

alar

ia P

f/Pv

Dev

ice

AL03

0M

edso

urce

Ozo

ne B

iom

edic

als

00

00

00

00

00

00

00

00

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.0

00

00

00

00

00

00

00

0

One

Step

Mal

aria

P.f/

Pan

Who

le B

lood

Tes

tW

62-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.0

00

00

00

00

00

00

00

0

OnSi

te M

alar

ia P

f/Pa

n Ag

Rap

id T

est

R011

3CCT

K Bi

otec

h, In

c.0

00

00

00

00

10

00

00

0

Para

scre

en®

- Ra

pid

Test

for M

alar

ia P

an/P

f50

3030

025

Zeph

yr B

iom

edic

als

00

00

00

00

00

00

00

00

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

Dia

gnos

tics,

Inc.

00

00

00

00

00

00

00

00

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pan

(HRP

II/pL

DH)

C30R

HA2

5Ra

piG

EN In

c.0

00

00

00

00

00

00

00

0

Pf a

nd P

vAd

vanc

ed Q

ualit

y™ O

ne S

tep

Mal

aria

(Pf

/Pv)

Tri-

line

Test

(w

hole

blo

od)

ITP1

1003

TC4

0In

Tec

Prod

ucts

, Inc

.0

00

00

00

00

00

00

00

0

BioT

race

r™ M

alar

ia P

.f/P.

v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

00

00

00

00

00

00

00

00

Core

test

s® O

ne S

tep

Mal

aria

Pf/

Pv A

g Te

st D

evic

eB4

2-21

/B42

-22

Core

Tec

hnol

ogy

Co.,

Ltd.

00

00

00

00

00

00

00

00

EzDx

™ M

alar

ia P

v/Pf

Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

03Ad

vy C

hem

ical

Priv

ate

Lim

ited

00

00

00

00

00

00

00

00

Falc

iVax

™ -

Rap

id T

est f

or M

alar

ia P

v/Pf

5030

1002

5Ze

phyr

Bio

med

ical

s0

00

00

00

00

00

00

00

0

An

ne

xes


Prod

uct

Prod

uct

code

Man

ufac

ture

r

Base

line

test

ing

35 °C

45 °C

Room

tem

pera

ture

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

Firs

t Res

pons

e® M

alar

ia A

g Pf

/Pv

Card

Tes

tPI

19FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

00

00

00

00

00

00

00

00

Hum

asis

Mal

aria

P.f/

P.v

Antig

en T

est

ANM

IV-7

025

Hum

asis

Co.

, Ltd

.0

00

00

00

00

00

00

00

0

KHB®

Mal

aria

Ag

P.f/

P.v

Rapi

d Te

stKH

-R-0

7-50

Shan

ghai

Keh

ua B

io-e

ngin

eerin

g Co

., Lt

d.0

00

00

00

00

00

00

00

0

Mal

aria

PV/

PF (p

LDH

/HRP

2) A

ntig

en T

est

Inf-

72N

anto

ng E

gens

Bio

tech

nolo

gy C

o., L

td.

00

00

00

00

00

00

00

00

Mer

iscr

een

Mal

aria

Pf/

Pv A

gM

FLRP

D-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.0

00

00

00

00

00

00

00

0

One

Step

Mal

aria

P.f/

P.v

Who

le B

lood

Tes

tW

056-

CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

00

00

00

00

00

00

00

00

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

d Te

stR0

112C

CTK

Biot

ech,

Inc.

00

00

00

00

00

00

00

00

Quic

kPro

file™

Mal

aria

Pf/

Pv T

est

7105

0Lu

miq

uick

Dia

gnos

tics,

Inc.

00

00

00

00

00

00

00

00

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pv

(HRP

II/pL

DH)

C40R

HA2

5Ra

piG

EN In

c.0

00

00

00

00

00

00

00

0

SD B

iolin

e M

alar

ia A

g P.

f/P.

v05

FK80

Stan

dard

Dia

gnos

tics,

Inc.

00

00

00

00

00

00

00

00

Pf a

nd P

f an

d Pv

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v -

HRP

2 ba

nd05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.0

00

00

00

00

00

00

00

0

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v -

Pf-p

LDH

ban

d05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.0

00

00

00

00

00

00

00

0

Pf, P

lasm

odiu

m fa

lcip

arum

P

v, Pl

asm

odiu

m v

ivax

p

an, P

lasm

odiu

m sp

ecie

s

Tabl

e A

4.12

(con

tinue

d)


Tabl

e A

4.12

a: H

eat

stab

ility

tes

ting

resu

lts

for

pan

or P

. viv

ax t

est

line

of c

ombi

natio

n RD

Ts o

n pa

rasi

te-n

egat

ive

sam

ples

. Po

siti

vity

rat

e at

bas

elin

e (r

oom

tem

pera

ture

) an

d af

ter

60 d

ays’

incu

batio

n at

roo

m t

empe

ratu

re, 3

5°C

and

45°C

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Base

line

test

ing

35 °C

45 °C

Room

tem

pera

ture

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

Pf a

nd P

anAT

OMOR

APID

™ M

ALAR

IA (P

F/PA

N)

MM

AL01

Atom

o Di

agno

stic

s PT

Y Li

mite

d0

00

00

01

00

10

00

00

0

BION

OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kit

RG19

-08

BioN

ote,

Inc.

00

00

00

00

00

00

00

00

BioT

race

r™ M

alar

ia P

.f/PA

N R

apid

Car

d17

012

Bio

Focu

s Co

., Lt

d.0

00

00

00

00

00

00

00

0

EzDx

™ M

alar

ia P

an/P

f Rap

id te

st d

etec

tion

Kit

RK M

AL 0

01Ad

vy C

hem

ical

Priv

ate

Lim

ited

00

00

00

00

00

00

00

00

Firs

t Res

pons

e® M

alar

ia A

g. p

LDH

/HRP

2 Co

mbo

Car

d Te

stPI

16FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

00

00

00

00

00

00

00

00

Hum

asis

Mal

aria

P.f/

Pan

Antig

en T

est

ANM

AL-7

025

Hum

asis

Co.

, Ltd

.0

00

00

00

00

01

00

00

0

Is It

… M

alar

ia P

f/Pv

Dev

ice

AL03

0M

edso

urce

Ozo

ne B

iom

edic

als

00

00

00

00

00

00

00

00

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.0

00

00

00

00

00

00

00

0

One

Step

Mal

aria

P.f/

Pan

Who

le B

lood

Tes

tW

62-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.0

00

00

00

00

00

00

00

0

OnSi

te M

alar

ia P

f/Pa

n Ag

Rap

id T

est

R011

3CCT

K Bi

otec

h, In

c.0

00

00

00

00

10

00

00

0

Para

scre

en®

- Ra

pid

Test

for M

alar

ia P

an/P

f50

3030

025

Zeph

yr B

iom

edic

als

00

00

00

00

00

00

00

00

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

Dia

gnos

tics,

Inc.

00

00

20

30

40

20

00

00

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pan

(HRP

II/pL

DH)

C30R

HA2

5Ra

piG

EN In

c.0

00

00

00

00

00

00

00

0

Pf a

nd P

vAd

vanc

ed Q

ualit

y ™

One

Step

Mal

aria

(Pf

/Pv)

Tri-

line

Test

(w

hole

blo

od)

ITP1

1003

TC4

0In

Tec

Prod

ucts

, Inc

.0

00

00

00

00

00

00

00

0

BioT

race

r™ M

alar

ia P

.f/P.

v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

00

00

00

00

00

00

00

00

Core

test

s® O

ne S

tep

Mal

aria

Pf/

Pv A

g Te

st D

evic

eB4

2-21

/B42

-22

Core

Tec

hnol

ogy

Co.,

Ltd.

00

00

00

00

00

00

00

00

EzDx

™ M

alar

ia P

v/Pf

Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

03Ad

vy C

hem

ical

Priv

ate

Lim

ited

00

00

00

00

00

00

00

00

Falc

iVax

™ -

Rap

id T

est f

or M

alar

ia P

v/Pf

5030

1002

5Ze

phyr

Bio

med

ical

s0

00

00

00

00

00

00

00

0

Firs

t Res

pons

e® M

alar

ia A

g Pf

/Pv

Card

Tes

tPI

19FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

00

00

00

00

00

00

00

00

Hum

asis

Mal

aria

P.f/

P .v

Antig

en T

est

ANM

IV-7

025

Hum

asis

Co.

, Ltd

.0

00

00

00

00

00

00

00

0

KHB®

Mal

aria

Ag

P.f/

P.v

Rapi

d Te

stKH

-R-0

7-50

Shan

ghai

Keh

ua B

io-e

ngin

eerin

g Co

., Lt

d.0

00

00

00

00

00

00

00

0

Mal

aria

PV/

PF (p

LDH

/HRP

2) A

ntig

en T

est

Inf-

72N

anto

ng E

gens

Bio

tech

nolo

gy C

o., L

td.

00

00

00

00

00

00

00

00

Mer

iscr

een

Mal

aria

Pf/

Pv A

gM

FLRP

D-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.0

00

00

00

00

00

00

00

0

One

Step

Mal

aria

P.f/

P.v

Who

le B

lood

Tes

tW

056-

CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

00

00

00

00

00

00

00

00

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

d Te

stR0

112C

CTK

Biot

ech,

Inc.

00

00

00

00

00

00

00

00

Quic

kPro

file™

Mal

aria

Pf/

Pv T

est

7105

0Lu

miq

uick

Dia

gnos

tics,

Inc.

00

00

00

00

00

00

00

00

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pv

(HRP

II/pL

DH)

C40R

HA2

5Ra

piG

EN In

c.0

00

00

00

00

00

00

00

0

SD B

iolin

e M

alar

ia A

g P.

f/P.

v05

FK80

Stan

dard

Dia

gnos

tics,

Inc.

00

00

00

00

00

00

00

00

Pf a

nd P

f an

d Pv

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.0

00

00

00

00

00

00

00

0

Pf, P

lasm

odiu

m fa

lcip

arum

P

v, Pl

asm

odiu

m v

ivax

p

an, P

lasm

odiu

m sp

ecie

s

An

ne

xes


Tabl

e A

4.13

: Hea

t st

abili

ty t

estin

g re

sult

s fo

r P.

falc

ipar

um t

est

line

on P

. viv

ax s

ampl

es a

t lo

w p

aras

ite

dens

ity

(200

par

asit

es/µ

L).

Posi

tivi

ty r

ate

at b

asel

ine

(roo

m t

empe

ratu

re)

and

afte

r 60

day

s’ in

cuba

tion

at r

oom

tem

pera

ture

, 35°

C an

d 45

°C

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Base

line

test

ing

35 °C

45 °C

Room

tem

pera

ture

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

Pf o

nly

BION

OTE

MAL

ARIA

P.f.

Ag

Rapi

d Te

st K

itRG

19-1

1Bi

oNot

e, In

c.0

00

00

00

00

00

00

00

0

Care

Star

t™ M

alar

ia H

RP2/

pLDH

(Pf)

G01

81/G

0181

-ET

Acce

ss B

io, I

nc.

00

00

00

00

00

00

00

00

EzDx

™ M

alar

ia P

f Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

08Ad

vy C

hem

ical

Priv

ate

Lim

ited

00

00

00

00

00

00

00

00

Firs

t Res

pons

e® M

alar

ia A

ntig

en P

. fal

cipa

rum

(HRP

2) C

ard

Test

PI13

FRC

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.0

00

00

00

00

00

00

00

0

Hum

asis

Mal

aria

P.f

Antig

en T

est

ANM

PF-7

025

Hum

asis

Co.

, Ltd

.0

00

00

00

00

00

00

00

0

Mal

aria

Ant

igen

Tes

t-Pf

MAG

0104

0Os

car M

edic

are

Pvt.

Ltd.

00

00

00

00

00

00

00

00

One

Step

Mal

aria

P.f

Who

le b

lood

Tes

tW

37-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.0

00

00

00

00

00

00

00

0

OnSi

te M

alar

ia P

f Ag

Rapi

d Te

stR0

114C

CTK

Biot

ech,

Inc.

00

00

00

00

00

00

00

00

Rapi

d 1-

2-3®

Hem

a® C

asse

tte

Mal

aria

PF

MAL

-PF-

CAS/

25 (1

00)

Hem

a Di

agno

stic

Sys

tem

s0

00

00

00

00

00

00

00

0

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

(HRP

II)C1

0RH

A25

Rapi

GEN

Inc.

00

00

00

00

00

00

00

00

Righ

tSig

n® M

alar

ia P

.f. R

apid

Tes

t Cas

sett

e (W

hole

Blo

od)

IMPF

-C51

Han

gzho

u Bi

otes

t Bio

tech

Co.

, Ltd

.0

00

00

00

00

00

00

00

0

SD B

iolin

e M

alar

ia A

g P.

f (H

RP2/

pLDH

) - H

RP2

band

05FK

90St

anda

rd D

iagn

ostic

s, In

c.0

00

00

00

00

00

00

00

0

SD B

iolin

e M

alar

ia A

g P.

f (H

RP2/

pLDH

) - P

f-pL

DH b

and

05FK

90St

anda

rd D

iagn

ostic

s, In

c.0

00

00

00

00

00

00

00

0

Pf a

nd P

anAT

OMOR

APID

™ M

ALAR

IA (P

F/PA

N)

MM

AL01

Atom

o Di

agno

stic

s PT

Y Li

mite

d0

00

00

00

00

00

00

00

0

BION

OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kit

RG19

-08

BioN

ote,

Inc.

00

00

00

00

00

00

00

00

BioT

race

r™ M

alar

ia P

.f/PA

N R

apid

Car

d17

012

Bio

Focu

s Co

., Lt

d.0

00

00

00

00

00

00

00

0

EzDx

™ M

alar

ia P

an/P

f Rap

id te

st d

etec

tion

Kit

RK M

AL 0

01Ad

vy C

hem

ical

Priv

ate

Lim

ited

00

00

00

00

00

00

00

00

Firs

t Res

pons

e® M

alar

ia A

g. p

LDH

/HRP

2 Co

mbo

Car

d Te

stPI

16FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

00

00

00

00

00

00

00

00

Hum

asis

Mal

aria

P.f/

Pan

Antig

en T

est

ANM

AL-7

025

Hum

asis

Co.

, Ltd

.0

00

00

00

00

00

00

00

0

Is It

… M

alar

ia P

f/Pv

Dev

ice

AL03

0M

edso

urce

Ozo

ne B

iom

edic

als

00

00

00

00

00

00

00

00

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.0

00

00

00

00

00

00

00

0

One

Step

Mal

aria

P.f/

Pan

Who

le B

lood

Tes

tW

62-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.0

00

00

00

00

00

00

00

0

OnSi

te M

alar

ia P

f/Pa

n Ag

Rap

id T

est

R011

3CCT

K Bi

otec

h, In

c.0

00

00

00

00

00

00

00

0

Para

scre

en®

- Ra

pid

Test

for M

alar

ia P

an/P

f50

3030

025

Zeph

yr B

iom

edic

als

00

00

00

00

00

00

00

00

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

Dia

gnos

tics,

Inc.

00

00

00

00

00

00

00

00

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pan

(HRP

II/pL

DH)

C30R

HA2

5Ra

piG

EN In

c.0

00

00

00

00

00

00

00

0

Pf a

nd P

vAd

vanc

ed Q

ualit

y ™

One

Step

Mal

aria

(Pf

/Pv)

Tri-

line

Test

(w

hole

blo

od)

ITP1

1003

TC4

0In

Tec

Prod

ucts

, Inc

.0

00

00

00

00

00

00

00

0

BioT

race

r™ M

alar

ia P

.f/P.

v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

00

00

00

00

00

00

00

00

Core

test

s® O

ne S

tep

Mal

aria

Pf/

Pv A

g Te

st D

evic

eB4

2-21

/B42

-22

Core

Tec

hnol

ogy

Co.,

Ltd.

00

00

00

00

00

00

00

00

EzDx

™ M

alar

ia P

v/Pf

Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

03Ad

vy C

hem

ical

Priv

ate

Lim

ited

00

00

00

00

00

00

00

00

Falc

iVax

™ -

Rap

id T

est f

or M

alar

ia P

v/Pf

5030

1002

5Ze

phyr

Bio

med

ical

s0

00

00

00

00

00

00

00

0

(con

tinue

d)


Prod

uct

Prod

uct

code

Man

ufac

ture

r

Base

line

test

ing

35 °C

45 °C

Room

tem

pera

ture

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

Firs

t Res

pons

e® M

alar

ia A

g Pf

/Pv

Card

Tes

tPI

19FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

00

00

00

00

00

00

00

00

Hum

asis

Mal

aria

P.f/

P.v

Antig

en T

est

ANM

IV-7

025

Hum

asis

Co.

, Ltd

.0

00

00

00

00

00

00

00

1

KHB®

Mal

aria

Ag

P.f/

P.v

Rapi

d Te

stKH

-R-0

7-50

Shan

ghai

Keh

ua B

io-e

ngin

eerin

g Co

., Lt

d.0

00

00

00

00

00

00

00

0

Mal

aria

PV/

PF (p

LDH

/HRP

2) A

ntig

en T

est

Inf-

72N

anto

ng E

gens

Bio

tech

nolo

gy C

o., L

td.

00

00

00

00

00

00

00

00

Mer

iscr

een

Mal

aria

Pf/

Pv A

gM

FLRP

D-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.0

00

00

00

00

00

00

00

0

One

Step

Mal

aria

P.f/

P.v

Who

le B

lood

Tes

tW

056-

CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

00

00

00

00

00

00

00

00

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

d Te

stR0

112C

CTK

Biot

ech,

Inc.

00

00

00

00

00

00

00

00

Quic

kPro

file™

Mal

aria

Pf/

Pv T

est

7105

0Lu

miq

uick

Dia

gnos

tics,

Inc.

00

00

00

00

00

00

00

00

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pv

(HRP

II/pL

DH)

C40R

HA2

5Ra

piG

EN In

c.0

00

00

00

00

00

00

00

0

SD B

iolin

e M

alar

ia A

g P.

f/P.

v05

FK80

Stan

dard

Dia

gnos

tics,

Inc.

00

00

00

00

00

00

00

00

Pf a

nd P

f an

d Pv

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v -

HRP

2 ba

nd05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.0

00

00

00

10

00

00

00

0

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v -

Pf-p

LDH

ban

d05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.0

00

00

00

10

00

00

00

0

Pf, P

lasm

odiu

m fa

lcip

arum

P

v, Pl

asm

odiu

m v

ivax

p

an, P

lasm

odiu

m sp

ecie

s

Tabl

e A

4.13

: Hea

t st

abili

ty t

estin

g re

sult

s fo

r P.

falc

ipar

um t

est

line

on P

. viv

ax s

ampl

es a

t lo

w p

aras

ite

dens

ity

(200

par

asit

es/µ

L).

Posi

tivi

ty r

ate

at b

asel

ine

(roo

m t

empe

ratu

re)

and

afte

r 60

day

s’ in

cuba

tion

at r

oom

tem

pera

ture

, 35°

C an

d 45

°C (c

ontin

ued)

An

ne

xes


Tabl

e A

4.14

: Hea

t st

abili

ty t

estin

g re

sult

s fo

r P.

falc

ipar

um t

est

line

on P

. viv

ax s

ampl

es a

t hi

gh p

aras

ite

dens

ity

(200

0 pa

rasi

tes/

µL).

Po

siti

vity

rat

e at

bas

elin

e (r

oom

tem

pera

ture

) an

d af

ter

60 d

ays’

incu

batio

n at

roo

m t

empe

ratu

re, 3

5°C

and

45°C

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Base

line

test

ing

35 °C

45 °C

Room

tem

pera

ture

Lot

1 (n

=2)

Lot

2 (n

=2)

Lot

1 (n

=2)

Lot

2 (n

=2)

Lot

1 (n

=2)

Lot

2 (n

=2)

Lot

1 (n

=2)

Lot

2 (n

=2)

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

Pf o

nly

BION

OTE

MAL

ARIA

P.f.

Ag

Rapi

d Te

st K

itRG

19-1

1Bi

oNot

e, In

c.0

00

00

00

00

00

00

00

0

Care

Star

t™ M

alar

ia H

RP2/

pLDH

(Pf)

G01

81/G

0181

-ET

Acce

ss B

io, I

nc.

00

00

00

00

00

00

00

00

EzDx

™ M

alar

ia P

f Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

08Ad

vy C

hem

ical

Priv

ate

Lim

ited

00

00

00

00

00

00

00

00

Firs

t Res

pons

e® M

alar

ia A

ntig

en P

. fal

cipa

rum

(HRP

2) C

ard

Test

PI13

FRC

Prem

ier M

edic

al C

orpo

ratio

n Lt

d.0

00

00

00

00

00

00

00

0

Hum

asis

Mal

aria

P.f

Antig

en T

est

ANM

PF-7

025

Hum

asis

Co.

, Ltd

.0

00

00

00

00

00

00

00

0

Mal

aria

Ant

igen

Tes

t-Pf

MAG

0104

0Os

car M

edic

are

Pvt.

Ltd.

00

00

00

00

00

00

00

00

One

Step

Mal

aria

P.f

Who

le b

lood

Tes

tW

37-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.0

00

00

00

00

00

00

00

0

OnSi

te M

alar

ia P

f Ag

Rapi

d Te

stR0

114C

CTK

Biot

ech,

Inc.

00

00

00

00

00

00

00

00

Rapi

d 1-

2-3®

Hem

a® C

asse

tte

Mal

aria

PF

MAL

-PF-

CAS/

25 (1

00)

Hem

a Di

agno

stic

Sys

tem

s0

00

00

00

00

00

00

00

0

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

(HRP

II)C1

0RH

A25

Rapi

GEN

Inc.

00

00

00

00

00

00

00

00

Righ

tSig

n® M

alar

ia P

.f. R

apid

Tes

t Cas

sett

e (W

hole

Blo

od)

IMPF

-C51

Han

gzho

u Bi

otes

t Bio

tech

Co.

, Ltd

.0

00

00

00

00

00

00

00

0

SD B

iolin

e M

alar

ia A

g P.

f (H

RP2/

pLDH

) - H

RP2

band

05FK

90St

anda

rd D

iagn

ostic

s, In

c.0

00

00

00

00

00

00

00

0

SD B

iolin

e M

alar

ia A

g P.

f (H

RP2/

pLDH

) - P

f-pL

DH b

and

05FK

90St

anda

rd D

iagn

ostic

s, In

c.0

00

00

00

00

00

00

00

0

Pf a

nd P

anAT

OMOR

APID

™ M

ALAR

IA (P

F/PA

N)

MM

AL01

Atom

o Di

agno

stic

s PT

Y Li

mite

d0

00

00

00

00

00

00

00

0

BION

OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kit

RG19

-08

BioN

ote,

Inc.

00

00

00

00

00

00

00

00

BioT

race

r™ M

alar

ia P

.f/PA

N R

apid

Car

d17

012

Bio

Focu

s Co

., Lt

d.0

00

00

00

00

00

00

00

0

EzDx

™ M

alar

ia P

an/P

f Rap

id te

st d

etec

tion

Kit

RK M

AL 0

01Ad

vy C

hem

ical

Priv

ate

Lim

ited

00

00

00

00

00

00

00

00

Firs

t Res

pons

e® M

alar

ia A

g. p

LDH

/HRP

2 Co

mbo

Car

d Te

stPI

16FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

00

00

00

00

00

00

00

00

Hum

asis

Mal

aria

P.f/

Pan

Antig

en T

est

ANM

AL-7

025

Hum

asis

Co.

, Ltd

.0

00

00

00

00

00

00

00

0

Is It

… M

alar

ia P

f/Pv

Dev

ice

AL03

0M

edso

urce

Ozo

ne B

iom

edic

als

00

00

00

00

00

00

00

00

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.0

00

00

00

00

00

00

00

0

One

Step

Mal

aria

P.f/

Pan

Who

le B

lood

Tes

tW

62-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.0

00

00

00

00

00

00

00

0

OnSi

te M

alar

ia P

f/Pa

n Ag

Rap

id T

est

R011

3CCT

K Bi

otec

h, In

c.0

00

00

00

00

00

00

00

0

Para

scre

en®

- Ra

pid

Test

for M

alar

ia P

an/P

f50

3030

025

Zeph

yr B

iom

edic

als

00

00

00

00

00

00

00

00

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

Dia

gnos

tics,

Inc.

00

00

00

00

00

00

00

00

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pan

(HRP

II/pL

DH)

C30R

HA2

5Ra

piG

EN In

c.0

00

00

00

00

00

00

00

0

Pf a

nd P

vAd

vanc

ed Q

ualit

y ™

One

Step

Mal

aria

(Pf

/Pv)

Tri-

line

Test

(w

hole

blo

od)

ITP1

1003

TC4

0In

Tec

Prod

ucts

, Inc

.0

00

00

00

00

00

00

00

0

BioT

race

r™ M

alar

ia P

.f/P.

v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

00

00

00

00

00

00

00

00

Core

test

s® O

ne S

tep

Mal

aria

Pf/

Pv A

g Te

st D

evic

eB4

2-21

/B42

-22

Core

Tec

hnol

ogy

Co.,

Ltd.

00

00

00

00

00

00

00

00

EzDx

™ M

alar

ia P

v/Pf

Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

03Ad

vy C

hem

ical

Priv

ate

Lim

ited

00

00

00

00

00

00

00

00

Falc

iVax

™ -

Rap

id T

est f

or M

alar

ia P

v/Pf

5030

1002

5Ze

phyr

Bio

med

ical

s0

00

00

00

00

00

00

00

0

(con

tinue

d)


Prod

uct

Prod

uct

code

Man

ufac

ture

r

Base

line

test

ing

35 °C

45 °C

Room

tem

pera

ture

Lot

1 (n

=2)

Lot

2 (n

=2)

Lot

1 (n

=2)

Lot

2 (n

=2)

Lot

1 (n

=2)

Lot

2 (n

=2)

Lot

1 (n

=2)

Lot

2 (n

=2)

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

Firs

t Res

pons

e® M

alar

ia A

g Pf

/Pv

Card

Tes

tPI

19FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

00

00

00

00

00

00

00

00

Hum

asis

Mal

aria

P.f/

P.v

Antig

en T

est

ANM

IV-7

025

Hum

asis

Co.

, Ltd

.0

00

00

00

00

00

00

00

0

KHB®

Mal

aria

Ag

P.f/

P.v

Rapi

d Te

stKH

-R-0

7-50

Shan

ghai

Keh

ua B

io-e

ngin

eerin

g Co

., Lt

d.0

00

00

00

00

00

00

00

0

Mal

aria

PV/

PF (p

LDH

/HRP

2) A

ntig

en T

est

Inf-

72N

anto

ng E

gens

Bio

tech

nolo

gy C

o., L

td.

00

00

00

00

00

00

00

00

Mer

iscr

een

Mal

aria

Pf/

Pv A

gM

FLRP

D-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.0

00

00

00

00

00

00

00

0

One

Step

Mal

aria

P.f/

P.v

Who

le B

lood

Tes

tW

056-

CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

00

00

00

00

00

00

00

00

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

d Te

stR0

112C

CTK

Biot

ech,

Inc.

00

00

00

00

00

00

00

00

Quic

kPro

file™

Mal

aria

Pf/

Pv T

est

7105

0Lu

miq

uick

Dia

gnos

tics,

Inc.

00

00

00

00

00

00

00

00

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pv

(HRP

II/pL

DH)

C40R

HA2

5Ra

piG

EN In

c.0

00

00

00

00

00

00

00

0

SD B

iolin

e M

alar

ia A

g P.

f/P.

v05

FK80

Stan

dard

Dia

gnos

tics,

Inc.

00

00

00

00

00

00

00

00

Pf a

nd P

f an

d Pv

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v -

HRP

2 ba

nd05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.0

00

00

00

00

00

00

00

0

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v -

Pf-p

LDH

ban

d05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.0

00

00

00

00

00

00

00

0

Pf, P

lasm

odiu

m fa

lcip

arum

P

v, Pl

asm

odiu

m v

ivax

p

an, P

lasm

odiu

m sp

ecie

s

Tabl

e A

4.14

: Hea

t st

abili

ty t

estin

g re

sult

s fo

r P.

falc

ipar

um t

est

line

on P

. viv

ax s

ampl

es a

t hi

gh p

aras

ite

dens

ity

(200

0 pa

rasi

tes/

µL).

Po

siti

vity

rat

e at

bas

elin

e (r

oom

tem

pera

ture

) an

d af

ter

60 d

ays’

incu

batio

n at

roo

m t

empe

ratu

re, 3

5°C

and

45°C

(con

tinue

d)

An

ne

xes


Tabl

e A

4.15

: Hea

t st

abili

ty t

estin

g re

sult

s fo

r P.

viv

ax t

est

line

on P

. fal

cipa

rum

sam

ples

at

low

par

asit

e de

nsit

y (2

00 p

aras

ites

/µL)

. Po

siti

vity

rat

e at

bas

elin

e (r

oom

tem

pera

ture

) an

d af

ter

60 d

ays’

incu

batio

n at

roo

m t

empe

ratu

re, 3

5°C

and

45°C

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Base

line

test

ing

35 °C

45 °C

Room

tem

pera

ture

Lot

1 (n

=15)

Lot

2 (n

=15)

Lot

1 (n

=15)

Lot

2 (n

=15)

Lot

1 (n

=15)

Lot

2 (n

=15)

Lot

1 (n

=15)

Lot

2 (n

=15)

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

Pf a

nd P

vAd

vanc

ed Q

ualit

y ™

One

Step

Mal

aria

(Pf

/Pv)

Tri-

line

Test

(w

hole

blo

od)

ITP1

1003

TC4

0In

Tec

Prod

ucts

, Inc

.0

00

00

00

00

00

00

00

0

BioT

race

r™ M

alar

ia P

.f/P.

v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

00

00

00

00

00

00

00

00

Core

test

s® O

ne S

tep

Mal

aria

Pf/

Pv A

g Te

st D

evic

eB4

2-21

/B42

-22

Core

Tec

hnol

ogy

Co.,

Ltd.

00

00

00

00

00

00

00

00

EzDx

™ M

alar

ia P

v/Pf

Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

03Ad

vy C

hem

ical

Priv

ate

Lim

ited

00

00

00

00

00

00

00

00

Falc

iVax

™ -

Rap

id T

est f

or M

alar

ia P

v/Pf

5030

1002

5Ze

phyr

Bio

med

ical

s0

00

00

00

10

00

00

00

0

Firs

t Res

pons

e® M

alar

ia A

g Pf

/Pv

Card

Tes

tPI

19FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

00

00

00

00

00

01

00

00

Hum

asis

Mal

aria

P.f/

P.v

Antig

en T

est

ANM

IV-7

025

Hum

asis

Co.

, Ltd

.0

00

00

00

00

00

00

00

0

KHB®

Mal

aria

Ag

P.f/

P.v

Rapi

d Te

stKH

-R-0

7-50

Shan

ghai

Keh

ua B

io-e

ngin

eerin

g Co

., Lt

d.0

00

00

00

00

00

00

00

0

Mal

aria

PV/

PF (p

LDH

/HRP

2) A

ntig

en T

est

Inf-

72N

anto

ng E

gens

Bio

tech

nolo

gy C

o., L

td.

00

00

00

00

00

01

00

01

Mer

iscr

een

Mal

aria

Pf/

Pv A

gM

FLRP

D-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.0

00

00

00

00

00

00

00

0

One

Step

Mal

aria

P.f/

P.v

Who

le B

lood

Tes

tW

056-

CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

00

00

00

00

00

00

00

00

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

d Te

stR0

112C

CTK

Biot

ech,

Inc.

00

00

00

00

00

00

00

00

Quic

kPro

file™

Mal

aria

Pf/

Pv T

est

7105

0Lu

miq

uick

Dia

gnos

tics,

Inc.

00

00

00

00

00

00

00

00

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pv

(HRP

II/pL

DH)

C40R

HA2

5Ra

piG

EN In

c.0

00

10

00

00

00

00

00

0

SD B

iolin

e M

alar

ia A

g P.

f/P.

v05

FK80

Stan

dard

Dia

gnos

tics,

Inc.

00

00

00

00

01

00

00

00

Pf a

nd P

f an

d Pv

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.0

00

00

00

00

00

00

00

0

Pf, P

lasm

odiu

m fa

lcip

arum

P

v, Pl

asm

odiu

m v

ivax

p

an, P

lasm

odiu

m sp

ecie

s


Tabl

e A

4.16

: Hea

t st

abili

ty t

estin

g re

sult

s fo

r P.

viv

ax t

est

line

on P

. fal

cipa

rum

sam

ples

at

high

par

asit

e de

nsit

y (2

000

para

site

s/µL

).

Posi

tivi

ty r

ate

at b

asel

ine

(roo

m t

empe

ratu

re)

and

afte

r 60

day

s’ in

cuba

tion

at r

oom

tem

pera

ture

, 35°

C an

d 45

°C

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Base

line

test

ing

35 °C

45 °C

Room

tem

pera

ture

Lot

1 (n

=5)

Lot

2 (n

=5)

Lot

1 (n

=5)

Lot

2 (n

=5)

Lot

1 (n

=5)

Lot

2 (n

=5)

Lot

1 (n

=5)

Lot

2 (n

=5)

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

No. positive

No. invalid

Pf a

nd P

vAd

vanc

ed Q

ualit

y ™

One

Step

Mal

aria

(Pf

/Pv)

Tri-

line

Test

(w

hole

blo

od)

ITP1

1003

TC4

0In

Tec

Prod

ucts

, Inc

.0

00

00

00

00

00

00

00

0

BioT

race

r™ M

alar

ia P

.f/P.

v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

00

00

00

00

00

00

00

00

Core

test

s® O

ne S

tep

Mal

aria

Pf/

Pv A

g Te

st D

evic

eB4

2-21

/B42

-22

Core

Tec

hnol

ogy

Co.,

Ltd.

00

00

00

00

00

00

00

00

EzDx

™ M

alar

ia P

v/Pf

Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

03Ad

vy C

hem

ical

Priv

ate

Lim

ited

00

00

00

00

00

00

00

00

Falc

iVax

™ -

Rap

id T

est f

or M

alar

ia P

v/Pf

5030

1002

5Ze

phyr

Bio

med

ical

s0

00

00

00

00

00

00

00

0

Firs

t Res

pons

e® M

alar

ia A

g Pf

/Pv

Card

Tes

tPI

19FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

01

00

00

00

00

00

00

00

Hum

asis

Mal

aria

P.f/

P.v

Antig

en T

est

ANM

IV-7

025

Hum

asis

Co.

, Ltd

.0

00

00

00

00

00

00

00

0

KHB®

Mal

aria

Ag

P.f/

P.v

Rapi

d Te

stKH

-R-0

7-50

Shan

ghai

Keh

ua B

io-e

ngin

eerin

g Co

., Lt

d.0

00

00

00

00

00

00

00

0

Mal

aria

PV/

PF (p

LDH

/HRP

2) A

ntig

en T

est

Inf-

72N

anto

ng E

gens

Bio

tech

nolo

gy C

o., L

td.

00

00

00

00

00

00

00

00

Mer

iscr

een

Mal

aria

Pf/

Pv A

gM

FLRP

D-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.0

00

00

00

00

00

00

00

0

One

Step

Mal

aria

P.f/

P.v

Who

le B

lood

Tes

tW

056-

CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

00

00

00

00

00

00

00

00

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

d Te

stR0

112C

CTK

Biot

ech,

Inc.

00

01

00

00

00

00

00

00

Quic

kPro

file™

Mal

aria

Pf/

Pv T

est

7105

0Lu

miq

uick

Dia

gnos

tics,

Inc.

00

00

00

00

00

00

00

50

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pv

(HRP

II/pL

DH)

C40R

HA2

5Ra

piG

EN In

c.0

00

00

00

00

00

00

00

0

SD B

iolin

e M

alar

ia A

g P.

f/P.

v05

FK80

Stan

dard

Dia

gnos

tics,

Inc.

00

00

00

00

00

00

00

00

Pf a

nd P

f an

d Pv

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.0

00

00

00

00

00

00

00

0

Pf, P

lasm

odiu

m fa

lcip

arum

P

v, Pl

asm

odiu

m v

ivax

p

an, P

lasm

odiu

m sp

ecie

s

An

ne

xes


Tabl

e A

4.17

: Hea

t st

abili

ty t

estin

g re

sult

s fo

r pa

n or

P. v

ivax

tes

t lin

e of

com

bina

tion

test

s on

a P

. viv

ax s

ampl

e at

low

par

asit

e de

nsit

y (2

00 p

aras

ites

/µL)

. Po

siti

vity

rat

e at

bas

elin

e (r

oom

tem

pera

ture

) an

d af

ter

60 d

ays’

incu

batio

n at

roo

m t

empe

ratu

re, 3

5°C

and

45°C

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Base

line

test

ing

35 °C

45 °C

Room

tem

pera

ture

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

Lot

1 (n

=4)

Lot

2 (n

=4)

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

Pf a

nd P

anAT

OMOR

APID

™ M

ALAR

IA (P

F/PA

N)

MM

AL01

Atom

o Di

agno

stic

s PT

Y Li

mite

d0

0N

D3

01.

03

01.

04

01.

04

01.

01

01.

02

01.

03

01.

0

BION

OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kit

RG19

-08

BioN

ote,

Inc.

40

1.0

20

1.0

40

1.0

40

1.0

40

1.0

30

1.0

40

1.0

40

1.0

BioT

race

r™ M

alar

ia P

.f/PA

N R

apid

Car

d17

012

Bio

Focu

s Co

., Lt

d.4

01.

84

02.

04

02.

04

01.

54

01.

34

01.

34

02.

04

01.

8

EzDx

™ M

alar

ia P

an/P

f Rap

id te

st d

etec

tion

Kit

RK M

AL 0

01Ad

vy C

hem

ical

Priv

ate

Lim

ited

40

1.0

40

1.0

40

1.0

40

1.0

40

1.0

40

1.0

40

1.0

40

1.0

Firs

t Res

pons

e® M

alar

ia A

g. p

LDH

/HRP

2 Co

mbo

Car

d Te

stPI

16FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

40

1.8

40

2.0

40

2.0

40

1.5

40

1.5

40

2.0

40

1.3

40

1.8

Hum

asis

Mal

aria

P.f/

Pan

Antig

en T

est

ANM

AL-7

025

Hum

asis

Co.

, Ltd

.2

01.

04

01.

04

01.

03

01.

03

01.

03

01.

04

01.

04

01.

0

Is It

… M

alar

ia P

f/Pv

Dev

ice

AL03

0M

edso

urce

Ozo

ne B

iom

edic

als

40

1.3

40

2.0

40

2.0

40

2.0

40

1.0

40

2.0

40

2.0

40

2.0

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.3

01.

02

01.

04

01.

03

01.

02

01.

00

0N

D4

01.

04

01.

0

One

Step

Mal

aria

P.f/

Pan

Who

le B

lood

Tes

tW

62-C

Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.1

01.

01

01.

00

0N

D2

01.

00

0N

D1

01.

00

0N

D0

0N

D

OnSi

te M

alar

ia P

f/Pa

n Ag

Rap

id T

est

R011

3CCT

K Bi

otec

h, In

c.4

01.

04

01.

04

01.

04

01.

04

01.

04

01.

04

01.

04

01.

0

Para

scre

en®

- Ra

pid

Test

for M

alar

ia P

an/P

f50

3030

025

Zeph

yr B

iom

edic

als

40

2.0

40

2.0

40

2.0

40

2.0

40

2.0

40

2.0

40

2.0

40

2.0

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

Dia

gnos

tics,

Inc.

40

1.0

40

1.0

40

1.0

40

1.5

40

1.0

40

1.0

40

1.0

40

1.3

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pan

(HRP

II/pL

DH)

C30R

HA2

5Ra

piG

EN In

c.4

01.

34

01.

04

01.

04

01.

34

02.

04

01.

04

02.

04

01.

3

Pf a

nd P

vAd

vanc

ed Q

ualit

y™ O

ne S

tep

Mal

aria

(Pf

/Pv)

Tri-

line

Test

(w

hole

blo

od)

ITP1

1003

TC4

0In

Tec

Prod

ucts

, Inc

.0

0N

D2

01.

03

01.

03

01.

04

01.

03

01.

03

01.

03

01.

0

BioT

race

r™ M

alar

ia P

.f/P.

v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

40

1.0

40

1.0

40

1.0

40

1.0

40

1.0

40

1.0

40

1.3

40

1.0

Core

test

s® O

ne S

tep

Mal

aria

Pf/

Pv A

g Te

st D

evic

eB4

2-21

/B42

-22

Core

Tec

hnol

ogy

Co.,

Ltd.

40

1.0

40

1.0

40

1.0

40

1.0

40

1.0

30

1.0

40

1.0

40

1.0

EzDx

™ M

alar

ia P

v/Pf

Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

03Ad

vy C

hem

ical

Priv

ate

Lim

ited

40

1.0

40

1.0

40

1.0

10

1.0

20

1.0

10

1.0

40

1.0

30

1.0

Falc

iVax

™ -

Rap

id T

est f

or M

alar

ia P

v/Pf

5030

1002

5Ze

phyr

Bio

med

ical

s4

02.

04

02.

04

02.

04

02.

04

02.

04

02.

04

02.

04

02.

0

Firs

t Res

pons

e® M

alar

ia A

g Pf

/Pv

Card

Tes

tPI

19FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

40

1.0

40

1.3

40

1.0

40

1.5

40

1.0

40

1.0

40

2.0

40

1.3

Hum

asis

Mal

aria

P.f/

P.v

Antig

en T

est

ANM

IV-7

025

Hum

asis

Co.

, Ltd

.4

01.

04

01.

04

01.

04

01.

04

01.

04

01.

04

01.

03

11.

0

KHB®

Mal

aria

Ag

P.f/

P.v

Rapi

d Te

stKH

-R-0

7-50

Shan

ghai

Keh

ua B

io-e

ngin

eerin

g Co

., Lt

d.2

01.

02

01.

04

01.

02

01.

04

01.

02

01.

04

01.

04

01.

0

Mal

aria

PV/

PF (p

LDH

/HRP

2) A

ntig

en T

est

Inf-

72N

anto

ng E

gens

Bio

tech

nolo

gy C

o., L

td.

40

1.0

40

1.0

40

1.0

30

1.0

20

1.0

00

ND

40

1.0

40

1.0

Mer

iscr

een

Mal

aria

Pf/

Pv A

gM

FLRP

D-01

Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.1

01.

00

0N

D2

01.

00

0N

D0

0N

D0

0N

D3

01.

02

01.

0

One

Step

Mal

aria

P.f/

P.v

Who

le B

lood

Tes

tW

056-

CG

uang

zhou

Won

dfo

Biot

ech

Co.,

Ltd.

00

ND

00

ND

00

ND

00

ND

00

ND

00

ND

00

ND

00

ND

OnSi

te M

alar

ia P

f/Pv

Ag

Rapi

d Te

stR0

112C

CTK

Biot

ech,

Inc.

40

1.0

40

1.0

40

1.0

40

1.0

30

1.0

40

1.0

40

1.0

40

1.0

Quic

kPro

file™

Mal

aria

Pf/

Pv T

est

7105

0Lu

miq

uick

Dia

gnos

tics,

Inc.

00

ND

00

ND

00

ND

00

ND

00

ND

00

ND

00

ND

30

1.0

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pv

(HRP

II/pL

DH)

C40R

HA2

5Ra

piG

EN In

c.4

01.

04

02.

04

01.

34

02.

04

01.

04

01.

84

01.

34

01.

8

SD B

iolin

e M

alar

ia A

g P.

f/P.

v05

FK80

Stan

dard

Dia

gnos

tics,

Inc.

40

1.0

40

2.0

40

2.0

40

2.0

40

2.0

40

2.0

40

2.0

40

1.8

Pf a

nd P

f an

d Pv

SD B

iolin

e M

alar

ia A

g P.

f/P.

f/P.

v05

FK12

0St

anda

rd D

iagn

ostic

s, In

c.4

01.

04

01.

04

01.

53

11.

34

02.

04

01.

34

02.

04

01.

5

ND,

not

det

erm

ined

Pf, P

lasm

odiu

m fa

lcip

arum

P

v, Pl

asm

odiu

m v

ivax

p

an, P

lasm

odiu

m sp

ecie

s


Tabl

e A

4.18

: Hea

t st

abili

ty t

estin

g re

sult

s fo

r pa

n or

P. v

ivax

tes

t lin

e of

com

bina

tion

test

s on

a P

. viv

ax s

ampl

e at

hig

h pa

rasi

te d

ensi

ty (2

000

para

site

s/µL

).

Posi

tivi

ty r

ate

at b

asel

ine

(roo

m t

empe

ratu

re)

and

afte

r 60

day

s’ in

cuba

tion

at r

oom

tem

pera

ture

, 35°

C an

d 45

°C

Prod

uct

Prod

uct

code

Man

ufac

ture

r

Base

line

test

ing

35 °C

45 °C

Room

tem

pera

ture

Lot

1 (n

=15)

Lot

2 (n

=15)

Lot

1 (n

=15)

Lot

2 (n

=15)

Lot

1 (n

=15)

Lot

2 (n

=15)

Lot

1 (n

=15)

Lot

2 (n

=15)

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

No. positive

No. invalid

Mean band intensity

Pf a

nd P

anAT

OMOR

APID

™ M

ALAR

IA (P

F/PA

N)

MM

AL01

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o Di

agno

stic

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mite

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02.

02

02.

02

02.

02

02.

02

02.

02

02.

02

02.

02

02.

0

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OTE

MAL

ARIA

P.f

& P

an A

g Ra

pid

Test

Kit

RG19

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BioN

ote,

Inc.

20

2.5

20

3.0

20

3.0

20

3.0

20

3.0

20

3.0

20

2.0

20

2.5

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race

r™ M

alar

ia P

.f/PA

N R

apid

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012

Bio

Focu

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., Lt

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03.

02

03.

52

03.

02

03.

02

03.

02

03.

02

03.

02

03.

0

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alar

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an/P

f Rap

id te

st d

etec

tion

Kit

RK M

AL 0

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vy C

hem

ical

Priv

ate

Lim

ited

20

2.0

20

3.0

20

3.0

20

3.0

20

3.0

20

2.5

20

3.0

20

3.0

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t Res

pons

e® M

alar

ia A

g. p

LDH

/HRP

2 Co

mbo

Car

d Te

stPI

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CPr

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r Med

ical

Cor

pora

tion

Ltd.

20

3.5

20

3.0

20

3.5

20

3.0

20

3.0

20

3.5

20

3.0

20

4.0

Hum

asis

Mal

aria

P.f/

Pan

Antig

en T

est

ANM

AL-7

025

Hum

asis

Co.

, Ltd

.2

02.

02

02.

02

03.

02

02.

02

02.

02

02.

52

02.

02

02.

5

Is It

… M

alar

ia P

f/Pv

Dev

ice

AL03

0M

edso

urce

Ozo

ne B

iom

edic

als

20

3.0

20

4.0

20

3.0

20

3.5

20

2.5

20

3.0

20

3.0

20

3.0

Mer

iscr

een

Mal

aria

Pf/

Pan

Ag

MH

LRPD

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Mer

il Di

agno

stic

s Pr

ivat

e Lt

d.2

02.

02

03.

02

02.

02

02.

02

02.

52

02.

02

02.

02

02.

5

One

Step

Mal

aria

P.f/

Pan

Who

le B

lood

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tW

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Gua

ngzh

ou W

ondf

o Bi

otec

h Co

., Lt

d.2

01.

52

02.

02

02.

02

02.

02

01.

02

01.

52

01.

52

01.

5

OnSi

te M

alar

ia P

f/Pa

n Ag

Rap

id T

est

R011

3CCT

K Bi

otec

h, In

c.2

02.

02

03.

02

02.

52

02.

52

02.

52

02.

52

03.

02

02.

5

Para

scre

en®

- Ra

pid

Test

for M

alar

ia P

an/P

f50

3030

025

Zeph

yr B

iom

edic

als

20

3.0

20

4.0

20

4.0

20

4.0

20

3.5

20

4.0

20

4.0

20

3.5

Quic

kPro

file™

Mal

aria

Pf/

Pan

Test

7106

3Lu

miq

uick

Dia

gnos

tics,

Inc.

20

2.5

20

3.0

20

3.0

20

3.0

20

2.5

20

3.0

20

2.0

20

3.0

Rapi

GEN

BIO

CRED

IT M

alar

ia A

g Pf

/Pan

(HRP

II/pL

DH)

C30R

HA2

5Ra

piG

EN In

c.2

02.

52

03.

02

02.

52

03.

02

03.

02

02.

52

03.

02

02.

5

Pf a

nd P

vAd

vanc

ed Q

ualit

y ™

One

Step

Mal

aria

(Pf

/Pv)

Tri-

line

Test

(w

hole

blo

od)

ITP1

1003

TC4

0In

Tec

Prod

ucts

, Inc

.2

01.

52

02.

52

02.

02

02.

02

01.

52

02.

02

02.

02

02.

5

BioT

race

r™ M

alar

ia P

.f/P.

v Ra

pid

Card

1741

2Bi

o Fo

cus

Co.,

Ltd.

20

2.5

20

2.5

20

3.0

20

2.0

20

2.5

20

2.0

20

2.5

20

3.0

Core

test

s® O

ne S

tep

Mal

aria

Pf/

Pv A

g Te

st D

evic

eB4

2-21

/B42

-22

Core

Tec

hnol

ogy

Co.,

Ltd.

20

2.0

20

2.0

20

3.0

20

2.5

20

3.0

20

2.5

20

3.0

20

3.0

EzDx

™ M

alar

ia P

v/Pf

Rap

id M

alar

ia a

ntig

en d

etec

tion

test

RK M

AL 0

03Ad

vy C

hem

ical

Priv

ate

Lim

ited

20

2.0

20

2.0

20

2.0

20

2.0

20

2.0

20

2.0

20

2.5

20

2.5

Falc

iVax

™ -

Rap

id T

est f

or M

alar

ia P

v/Pf

5030

1002

5Ze

phyr

Bio

med

ical

s2

03.

02

04.

02

03.

52

03.

52

04.

02

03.

52

04.

02

03.

0

Firs

t Res

pons

e® M

alar

ia A

g Pf

/Pv

Card

Tes

tPI

19FR

CPr

emie

r Med

ical

Cor

pora

tion

Ltd.

20

2.0

20

2.5

20

3.0

20

3.5

20

2.5

20

3.0

20

4.0

20

3.5

Hum

asis

Mal

aria

P.f/

P.v

Antig

en T

est

ANM

IV-7

025

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asis

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02.

02

02.

52

03.

02

02.

52

02.

52

02.

52

03.

02

03.

0

KHB®

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Ag

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d Te

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02.

02

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52

02.

52

02.

52

02.

02

02.

02

02.

02

02.

5

Mal

aria

PV/

PF (p

LDH

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2) A

ntig

en T

est

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anto

ng E

gens

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tech

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gy C

o., L

td.

20

2.0

20

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20

2.5

20

2.0

20

2.0

20

2.0

20

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20

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Mer

iscr

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Mal

aria

Pf/

Pv A

gM

FLRP

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agno

stic

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02.

02

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02

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02

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02

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02

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52

02.

02

02.

0

One

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aria

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P.v

Who

le B

lood

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dfo

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ech

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20

1.5

20

1.0

20

1.0

20

1.0

20

1.0

20

1.0

20

2.0

20

1.5

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te M

alar

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f/Pv

Ag

Rapi

d Te

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ech,

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20

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20

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20

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20

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file™

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aria

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est

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20

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20

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20

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IT M

alar

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g Pf

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e M

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20

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20

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20

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20

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20

3.5

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nd P

f an

d Pv

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iolin

e M

alar

ia A

g P.

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f/P.

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rd D

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ostic

s, In

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02

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02

03.

52

03.

02

03.

02

03.

02

03.

0

Pf, P

lasm

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P

v, Pl

asm

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an, P

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m sp

ecie

s

An

ne

xes


Annex 5: Introducing rdt-based malaria diagnosis into national programmesIntroduction of parasite-based diagnosis at small clinics and at village level for case management poses many challenges, not only of logistics but also in managing the health-seeking and health-providing behaviour of patients and health workers. These can be addressed by a clear, time-bound strategic plan covering planning, implementation, monitoring and evaluation of the diagnosis programme, which must begin well before RDTs are procured. Furthermore, funding for the programme must include a significant component for planning and coordination, sensitization, information, education and communication, training, quality assurance, monitoring, supervision and logistics, in addition to procurement. In the absence of such funding, much of the expenditure on RDTs will be wasted, and loss of confidence in RDT-based

diagnosis can hinder strengthening of appropriate malaria case management. A focal person or persons should be available to coordinate the overall implementation plan and to ensure that the various agencies involved understand the process and their own roles.

Examples of successful wide-scale introduction of malaria RDTs by various national programmes and comprehensive technical guidance on achieving universal access to malaria diagnostic testing have been reported (8–9). Figures A5.1 and A5.2 give examples of the steps and timelines for RDT implementation and budget components for a malaria diag-nosis programme, respectively. These will have to be modified considerably for each programme.

Key challenges

Changing past thinking that “fever equals malaria unless proven otherwise”.

Introducing RDTs will disprove this statement. To have an impact on malaria diagnosis and treatment, RDTs must be seen to provide an accurate diagnosis by both health workers and patients, that is, they must be as good or better than those relied on previously. A health worker requires a good alternative to antimalarial medicines for the management of parasite-negative febrile patients. To achieve and maintain confidence in RDT-based diagnosis, a good quality assurance system must be in place. There must be satisfactory education of health workers and widespread community sensitization. Health workers should have understanding of other causes of fever in order to devise appropriate management algorithms for parasite-negative cases.

Changing and enforcing regulatory requirements

At the national level, regulation might be required to control the importation and use of malaria RDTs, and new procedures for storage, distribution and inventory management, such as those used for medicines, might be necessary.


Figu

re A

5.1.

Exa

mpl

e of

mal

aria

RDT

impl

emen

tatio

n st

eps

and

timel

inea

RDT

IMPL

EMEN

TATI

ON

TIM

ELIN

E

Coor

dina

ting

grou

pAp

poin

t m

alar

ia d

iagn

osis

coor

dina

tor(

s)

Polic

y re

com

men

datio

nsW

ritte

nM

oH e

ndor

sem

ent

Prog

ram

me

plan

ning

Guid

elin

esb

Writ

ten

MoH

end

orse

men

t

Case

man

agem

ent

of f

ever

of

unkn

own

orig

in

Case

man

agem

ent

of m

alar

ia

RDT

(and

mic

rosc

opy)

qua

lity

assu

ranc

e

RDT

tran

spor

t an

d st

orag

e

Deci

de d

istric

ts f

or in

itial

/ ph

ased

impl

emen

tatio

n

Feve

r m

anag

emen

t al

gorit

hmW

ritte

nM

oH e

ndor

sem

ent

Com

mun

ity s

ensit

izat

ion

Gene

ral h

ealth

car

e pr

ovid

ers’

educ

atio

n

Dete

rmin

e / d

esig

nate

tran

spor

t and

stor

age

met

hods

Regu

lato

ry is

sues

Defin

e co

llabo

rativ

e ro

les (

NM

P an

d re

gula

tory

bod

y)

Writ

e/ad

opt

regu

lato

ry g

uide

lines

Crea

te R

DT r

egist

ry f

or r

efer

ence

Dsse

min

ate

regu

lato

ry c

riter

ia

Prod

uct s

elec

tion,

sup

ply

chai

n m

anag

emen

tSe

lect

sev

eral

pro

duct

s

Sam

ples

for

eas

e-of

-use

ass

essm

ent

Fina

l dec

ision

on

RDT

Neg

otia

te s

peci

ficat

ions

with

man

ufac

ture

r

Com

petit

ive

bidd

ing

and

proc

urem

ent

Depe

nden

t on

regis

tratio

n pr

oces

s

Rece

ive

first

bat

ch (o

f st

agge

red

deliv

ery)

Dist

ribut

ion

to f

ield

Proc

ure

glov

es

Proc

ure

shar

ps b

oxes

Proc

ure

othe

r as

soci

ated

mat

eria

ls

RDT

qual

ity c

ontr

olW

rite

sent

inel

site

SO

P

Set u

p/en

gage

fiel

d-ba

sed

qual

ity co

ntro

l mon

itorin

g sit

es

Deci

de o

n lo

t-te

stin

g sit

eDe

term

ine

site

Com

men

ce t

estin

g

Post

-mar

ketin

g su

rvei

llanc

ec

An

ne

xes


Trai

ning

Cond

uct

case

man

agem

ent

trai

ning

for

fev

erM

ay b

e co

nduc

ted

earli

er, o

r al

read

y in

pla

ce

Mod

ify R

DT in

stru

ctio

ns a

nd t

rain

ing

man

ual

Fiel

d-te

st m

odifi

ed t

rain

ing/

inst

ruct

ions

Trai

ning

of

trai

ners

and

sup

ervi

sors

Hea

lth w

orke

r tr

aini

ng

Advo

cacy

, com

mun

icat

ion,

soc

ial m

obili

zatio

nEn

gagi

ng c

ivil

soci

ety

orga

niza

tions

Com

mun

ity s

ensit

izat

ion

Enga

ging

opi

nion

lead

ers

Gene

ral h

ealth

car

e ed

ucat

ion

Mon

itorin

g an

d ev

alua

tion

Deve

lop/

adop

t ap

prop

riate

rec

ord

form

s

Defin

e m

etho

ds f

or c

aptu

ring

diff

eren

t in

dica

tors

Inte

grat

e RD

Ts in

to t

he r

outin

e he

alth

info

rmat

ion

man

agem

ent

syst

em

Plan

for

a p

ost-

intr

oduc

tion

prog

ram

me

revi

ew

MoH

, min

istr

y of

hea

lth; N

MP,

nat

iona

l mal

aria

pro

gram

me

a Ad

apte

d w

ith p

erm

issi

on fr

om F

IND

and

Uga

nda

Nat

iona

l Mal

aria

Con

trol

Pro

gram

me

b M

ay a

lread

y be

in p

lace

c Se

ntin

el s

ite m

icro

scop

y, po

ssib

ly p

ositi

ve c

ontr

ol w

ells

in fu

ture

Figu

re A

5.1

(con

tinue

d)


Figure A5.2. Components of the budget for a malaria diagnosis programmea

Component Activities specific to microscopy

Activities specific to RDTs

Activities for management of malaria and non-malaria fevers

Preparation of technical guidelines, standard operating procedures and checklists

Guidelines Laboratory supervisionb RDT transport and storage Fever management algorithm

Standard operating procedures for diagnostic testing Microscopy performance RDT performance Other tests used at primary

care level

Other standard operating procedures Proficiency testing, validation of routine slide results RDT storage

Training material Training manual for microscopy Training manual for RDTs

Training manuals for integrated management of fevers

Checklists for supervision Laboratory visitsb Health facility visits

Procurement and supply of commodities

Diagnostic tests Microscopes and related supplies RDT kits

Urine dipsticks, haemoglobin meter, haematocrit meter, glucometer

Medicines Artemisinin-based combination therapy Antibiotics, zinc, inhaled salbutamol, rehydration salts

Other commodities Gloves, lancets, alcohol, cotton-wool, timers, sharps boxes

Distribution of commodities to the field All items listed above

Quality management system

Pre-shipment testing Lot-testing

Training of focal people Quality management system for focal people

Monitoring the quality management system

Quality monitoring supervision visits and compilation of health information management data

Training of health workers

Training of tutors Expert microscopists Tutors for RDT performance outside laboratories and clinical management of fever cases

Training of health workers Microscopists Health workers Clinicians

Training of supervisors Laboratory supervisorsb Clinical supervisors

Supervision

Supervisory visits Laboratory visitsb Health facility visits

Advocacy, communication and social mobilization

Design of strategies and material Communication on the need for malaria testing Communication on other causes of fever

Dissemination of key messages Through each delivery channel

Monitoring and evaluation

Updating the health information management system

Add row for RDTs in laboratory report and column for malaria test results in clinicians’ book

Column for other test results in clinicians’ book

Train health workers in the new health information management system

Training of person in charge or focal person for reporting on health information management in health facilities

a Adapted with permission (8)b For simplicity, activities specific to laboratories are listed under ‘Microscopy’, although both microscopy and RDT are generally performed in laboratories.

An

ne

xes


references1. Gamboa D, Ho MF, Bendezu J, et al. A large proportion of P. falciparum isolates in the Amazon region of Peru lack

pfhrp2 and pfhrp3: implications for malaria rapid diagnostic tests. PLoS One, 2010: 5(1): e8091.



4. Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 3 (2010–11). Geneva: World Health Organization; 2011.



7. Good practices for selecting and procuring rapid diagnostic tests for malaria. Geneva: World Health Organization; 2011.

8. Universal access to malaria diagnostic testing: an operational manual. Geneva: World Health Organization; 2011.

9. Thiam S, Thior M, Faye B, et al. Major reduction in anti-malarial drug consumption in Senegal after nation-wide introduction of malaria rapid diagnostic tests. PLoS One 2011; 6: e18419.

10. Harvey SA, Jennings L, Chinyama M, et al., Improving community health worker use of malaria rapid diagnostic tests in Zambia: package instructions, job aid and job aid-plus-training. Malar J 2008; 7(1): 160.


Notes

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