Malaria Rapid Diagnostic Test Performance Results of WHO product testing of malaria RDTs: Round 4 (2012)
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Mala
ria R
apid
Diag
nost
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st Pe
rform
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Re
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Malaria Rapid Diagnostic Test Performance
Results of WHO product testing of malaria RDTs: Round 4 (2012)
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Malaria Rapid Diagnostic Test Performance
Results of WHO product testing of malaria RDTs: 4 (2012)
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WHO Library Cataloguing-in-Publication Data :Malaria rapid diagnostic test performance: results of WHO product testing of malaria RDTs: round 4 (2012).1.Malaria - diagnosis. 2.Antimalarials - therapeutic use. 3.Malaria - drug therapy. 4.Diagnostic tests, Routine. 5.Reagent kits, Diagnostic - utilization. 6.Sensitivity and specificity. I.UNICEF/UNDP/World Bank/WHO Special Programme for Research and Training in Tropical Diseases. II.Centers for Disease Control (U.S.). III.Foundation for Innovative New Diagnostics.
ISBN 978 92 4 150472 0 (NLM classification: WC 750)
Copyright © World Health Organization on behalf of the Special Programme for Research and Training in Tropical Diseases 2012
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) I I I
Contents acknoWledgeMents ViiiabbreViations X
1. sUMMarY perforMance of Malaria rdts: WHo prodUct testing: roUnds 1–4 11.1. introduction 11.2. the WHo product testing programme 11.3. results of the evaluation 21.4. summary of outcomes 31.5. Use of these results 3
2. WHo Malaria rdt prodUct testing: roUnd 4 eXecUtiVe sUMMarY 172.1. introduction 172.2. the WHo product testing programme 172.3. results of the evaluation 182.4. Use of these results 18
3. backgroUnd 19
4. objectiVe 21
5. Materials and MetHods 215.1. test selection 215.2. outline of the product testing protocol 215.3. evaluation panels 245.4. rdt registration 255.5. specimen panel registration 255.6. test phases 255.7. performing rapid tests 255.8. interpretation of results 26
6. data ManageMent 27
7. QUalitY assUrance 27
8. etHical considerations 28
9. data analYsis 289.1. Measures of parasite detection: panel detection score
and positivity rates 289.2. false-positive results 28
9.2.1. incorrect species identification 299.2.2. false-positives from plasmodium-negative samples 29
9.3. band intensity 299.4. lot agreement 299.5. invalid tests 299.6. Heat (thermal) stability 29
10. laboratorY VersUs field-based Malaria rdt eValUations 30
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)IV
11. resUlts 3111.1. summary 3111.2. phase 1 - p. falciparum culture panel 3611.3. phase 2 - Wild-type p. falciparum and p. vivax
and plasmodium spp. negative samples 3711.3.1. p. falciparum detection 3711.3.2. p. vivax detection 3811.3.3. combined detection of p. falciparum and p. vivax 3811.3.4. p. falciparum and p. vivax positivity rate 3911.3.5. band intensity 4011.3.6. false-positive rates 40
12. Heat stabilitY 4412.1. p. falciparum test lines 4712.2. pan-specific test lines 49
13. ease-of-Use description 51
14. discUssion of keY findings 5514.1. panel detection score (pds) and its relationship
to sensitivity 5514.2. false-positive rate and specificity 5614.3. Heat (thermal) stability 5714.4. ease-of-use description 5714.5. inter-lot variability 5814.6. target antigens and species 58
15. Using tHese resUlts to ensUre QUalitY of diagnosis in tHe field 5915.1. beyond procurement 5915.2. lot testing 59
16. conclUsions 60
17. references 60
anneXes 63annex 1: characteristics of rapid malaria tests in round 4 64annex 2: Malaria rdt guide to results interpretation 67annex 3: phase 1 results 82annex 4: phase 2 results 86annex 5a: selection of an appropriate rdt 118annex 5b: Malaria rdt field assessment and rdt anomalies 119annex 6: introducing rdt-based malaria diagnosis into national programmes 122
Reference to any company or product in this report, particularly in any of the figures or tables, does not in any way imply an endorsement, certification, warranty of fitness or recommendation by WHO of any company or product for any purpose, and does not imply preference over products of a similar nature that are not mentioned. WHO furthermore does not warrant that: (1) any list of companies or products is complete and/or error free; and/or that (2) any products listed 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 in this report does not furthermore imply any approval by WHO of the products in question (which is the sole prerogative of national authorities). Any lists of RDTs are not an exhaustive list of malaria RDTs. Such lists reflect those products which have been submitted for evaluation in Round 4 of the WHO Malaria RDT Product Testing Programme. The fact that certain products are not included in any list means that they have not or not yet been submitted for evaluation in the WHO Malaria RDT Product Testing Programme and does not indicate anything in respect of such products’ performance. WHO will not accept any liability or 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 whatsoever included in this report. This report may not be used by manufacturers and suppliers for commercial or promotional purposes.
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) V
figUres
Figure S1: MalariaRDTperformanceinPhase2ofRounds1–4againstwild-type(clinical)samplescontainingP. falciparum atlow(200)andhigh(2000or5000)parasitedensities(parasites/µl)andclean-negativesamples
Figure S2: MalariaRDTperformanceinPhase2ofRounds1–4againstwild-type(clinical)samplescontainingP. vivax atlow(200)andhigh(2000or5000)parasitedensities(parasites/µl)andclean-negativesamples
Figure 1: Modeofactionofantigen-detectingmalariaRDTs
Figure 2: Networkofspecimencollection,characterizationandtestingsites
Figure 3: MalariaRDTProductTestingOverview
Figure 4a: OriginofPhase2P. falciparumwild-type(clinical)samples
Figure 4b: OriginofPhase2P. vivaxwild-type(clinical)samples
Figure 5: Testingprocedureandcalculationof‘paneldetectionscore’andbandintensityforProductAagainstasampledensityof200parasites/µl
Figure 6: Testingprocedureandcalculationof‘paneldetectionscore’andbandintensityforProductAagainstasampledensityof2000parasites/µl
Figure 7: Phase1P. falciparumpaneldetectionscoreofmalariaRDTsatlow(200)andhigh(2000)parasitedensities(parasites/µl)accordingtotargetantigentype(HRP2orpLDH)
Figure 8: Phase2P. falciparumpaneldetectionscoreofmalariaRDTsatlow(200)andhigh(2000)parasitedensity(parasites/µl)accordingtotargetantigentype(HRP2orpLDH)
Figure 9: Phase2P. vivaxpaneldetectionscoreofmalariaRDTsatlow(200)andhigh(2000)parasitedensities(parasites/µl)accordingtotargetantigentype(aldolase,pLDH)
Figure 10: Phase2P. falciparumpaneldetectionscoreandpositivityrateat200parasites/µl
Figure 11: Phase2P. vivaxpaneldetectionscoreandpositivityrateat200parasites/µl
Figure 12: Phase2P. falciparum(P. falciparumtestline)false-positiverateagainstclean-negativesamples
Figure 13: Phase2Plasmodiumspp.(panorP. vivax /Pvom testline)false-positiverateagainstclean-negativesamples
Figure 14: Phase2P. falciparumfalse-positiverateversusP. falciparumpaneldetectionscoreatlow(200)parasitedensity(parasites/µl)
Figure 15: Phase2P. vivaxfalse-positiverateversusP. vivaxpaneldetectionscoreatlow(200)parasitedensity(parasites/µl)
Figure 16: HeatstabilityofP. falciparum-specifictestlineofP. falciparum-onlytestsagainstalowdensityP. falciparumsample(200parasites/µl).Positivityrateatbaseline,andafter60daysincubation
Figure 17: HeatstabilityofP. falciparum-specifictestlineofP. falciparum-onlytestsagainstahighdensityP. falciparumsample(2000parasites/µl).Positivityrateatbaseline,andafter60daysincubation
Figure 18: HeatstabilityofP. falciparum-specifictestlineincombinationtestsagainstalowdensityP. falciparum sample(200parasites/µl).Positivityrateatbaseline,andafter60daysincubation
Figure 19: HeatstabilityofP. falciparumspecifictestlineincombinationtestsagainstahighdensityP. falciparum sample(2000parasites/µl).Positivityrateatbaseline,andafter60daysincubation
Figure 20: Heatstabilityofpan-lineofpan-specifictestsagainstalowdensityP. falciparumsample(200parasites/µl).Positivityrateatbaseline,andafter60daysincubation
Figure 21: Heatstabilityofpan-lineofpan-specifictestsagainstahighdensityP. falciparumsample(2000parasites/µl).Positivityrateatbaseline,andafter60daysincubation
Figure 22: Heatstabilityofpan-lineofcombinationtestsagainstalowdensityP. falciparumsample(200parasites/µl).Positivityrateatbaseline,andafter60daysincubation
Figure 23: Heatstabilityofpan-lineofcombinationtestsagainstahighdensityP. falciparumsample(2000parasites/µl).Positivityrateatbaseline,andafter60daysincubation
Figure A5.1: HowtoselectofanappropriateRDT
Figure A5.2: MalariaRDTanomaliesencounteredinproductionlots
Figure A6.1: ExampleofmalariaRDTimplementationstepsandtimeline
Figure A6.2: Componentsofthebudgetforamalariadiagnosisprogramme
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)VI
tables
Table S1: MalariaRDTPhase2performanceinRounds1–4againstwild-type(clinical)samplescontainingP. falciparum and P. vivax atlow(200)andhigh(2000or5000)parasitedensities(parasites/µl)andclean-negativesamples
Table S2: MalariaRDTRounds1–4heatstabilityresultsonacultured P. falciparum sampleatlow(200)andhigh(2000)parasitedensity(parasites/µl).Positivityrateatbaseline,andafter60daysincubationat35°Cand45°C
Table S3: Productresubmissions:WHOMalariaRDTProductTesting(Rounds1–4)
Table 1: ManufacturersandproductsacceptedintoRound4ofWHOMalariaRDTProductTestingProgramme
Table 2: CharacteristicsofPlasmodiumspp.negativespecimens
Table 3: SummaryPhase1performanceof48malariaRDTsagainst20culturedP. falciparumlinesatlow(200)andhigh(2000)parasitedensities(parasites/µl)
Table 4: SummaryPhase2performanceof46malariaRDTsagainstwild-type(clinical)P. falciparumandP. vivaxsamplesatlow(200)andhigh(2000)parasitedensities(parasites/µl)andPlasmodiumspp.negativesamples
Table 5: Heatstabilitytestingresultsfor46malariaRDTsonaculturedP. falciparumsampleatlow(200)andhigh(2000)parasitedensities(parasites/µl).Positivityrateatbaseline,andafter60daysincubationat35°Cand45°C
Table 6: Ease-of-usedescriptionof48malariaRDTs
Table A3.1: LotvariabilityinpositiveresultsagainstP. falciparumculturesamplesatlow(200)andhigh(2000or5000)parasitedensities(parasites/µl)
Table A3.2: Distributionoftestbandintensityscores(0–4)againstPhase1P. falciparumculturedparasitesatlow(200)andhigh(2000)parasitedensities(parasites/µl)
Table A4.1: LotvariabilityinpositiveresultsagainstPhase2wild-typeP. falciparumandP. vivaxsamplesatlow(200)andhigh(2000)parasitedensities(parasites/µl)
Table A4.2: Distributionoftestbandintensity(0–4)scoresagainstPhase2wild-typeP. falciparumsamplesatlow(200)andhigh(2000)parasitedensities(parasites/µl)
Table A4.3: DistributionofPan/Pvtestbandintensity(0–4)scoresforPhase2wild-typeP. vivaxsamplesatlow(200)andhigh(2000)parasitedensities(parasites/µl)
Table A4.4: PaneldetectionscoreofPhase2wild-typeP. falciparuminlow(200)andhigh(2000)parasitedensities(parasites/µl)bycontinent
Table A4.5: Phase2P. falciparumtestlinefalse-positiveratesforwild-typeP. vivaxsamplesatlow(200)andhigh(2000)parasitedensities(parasites/µl)
Table A4.6: Phase2Pan(orP. vivax)testlinefalse-positiveratefornon-Pfinfectiononwild-typeP. falciparumsamplesatlow(200)andhigh(2000)parasitedensities(parasites/µl)
Table A4.7: Phase2false-positiverateforP. falciparumtestlineresultsonallmalaria-negativesamples
Table A4.8: Phase2false-positiverateforP. falciparuminsamplescontainingspecificnon-malarialinfectiouspathogens
Table A4.9: Phase2false-positiverateforP. falciparuminsamplescontainingpotentiallycross-reactingbloodimmu-nologicalfactors
Table A4.10: Phase2false-positiverateforpan/P. vivax/Pvomtestlineresultsonallmalaria-negativesamples
Table A4.11: HeatstabilitytestingresultsforP. falciparum(orpan)testlineonaP. falciparumsampleatlowparasitedensity(200parasites/µl).Positivityrateatbaseline,andafter60daysincubationat4°C,35°Cand45°C
Table A4.11a: HeatstabilitytestingresultsforpantestlineofcombinationRDTsonaP. falciparumsampleatlowparasitedensity(200parasites/µl).Positivityrateatbaseline,andafter60daysincubationat4°C,35°Cand45°C
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) VII
Table A4.12: HeatstabilitytestingresultsforP. falciparum(orpan)testlineonaP. falciparumsampleathighparasitedensity(2000parasites/µl).Positivityrateatbaseline,andafter60daysincubationat4°C,35°Cand45°C
Table A4.12a: HeatstabilitytestingresultsforpantestlineofcombinationRDTsonaP. falciparumsampleathighparasitedensity(2000parasites/µl).Positivityrateatbaseline,andafter60daysincubationat4°C,35°Cand45°C
Table A4.13: HeatstabilitytestingresultsforP. falciparum(orpan)testlineonparasite-negativesamples.Positivityrateatbaseline,andafter60daysincubationat4°C,35°Cand45°C
Table A4.13a: HeatstabilitytestingresultsforpantestlineofcombinationRDTsonparasite-negativesamples.Positivityrateatbaseline,andafter60daysincubationat4°C,35°Cand45°C
Table A5.1 MalariaRDTfieldassessmentofpackaging,safetyandease-of-usetoguideproductselection
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)VIII
acknoWledgeMents
TheevaluationdescribedinthisreportwasajointprojectoftheWorldHealthOrganization(WHO)GlobalMalariaProgramme(GMP),theFoundationforInnovativeNewDiagnostics(FIND),theSpecialProgrammeforResearchandTraininginTropicalDiseasessponsoredbyUNICEF,UNDP,WorldBankandWHO(TDR)andtheUSCentersforDiseaseControlandPrevention(CDC),undertheWHO-FINDMalariaRDTEvaluationProgramme.TheprojectwasfinancedbyFIND,throughgrantsfromtheBillandMelindaGatesFoundation,theGlobalFundtofightAIDS,TuberculosisandMalaria,theUnitedStatesAgencyforInternationalDevelopment(USAID),andtheUKDepartmentforInternationalDevelopment(DFID),andbyTDR.Theprojectwouldnothavebeenpossiblewithoutthecooperationandsupportofthespecimencollectionsites,andthespecimencharacterizationlaboratoriesmentionedherein,andacknowledgesthetechnicaladvicefrommanymalariadiagnosticmanufacturersanddevelopersinthedevelopmentoftheprogramme.ThisreportonRound4ofWHOMalariaRDTProductTestingwascompiledbyJaneCunningham(WHO/GMP,Switzerland)andDavidBell(FoundationforInnovativeNewDiagnostics(FIND),Switzerland)
TheMalariaRDTEvaluationProgrammeofWHO,TDRandFINDisgratefultoallthosewhocontributedtotheconductoftheevaluationandpreparationofthisRound4report.
Salim Abdullah IfakaraHealthResearchandDevelopmentCentre,UnitedRepublicofTanzania
Yong Ah USCentersforDiseaseControlandPrevention/NationalCenterforGlobalHealth/DivisionofMalariaandParasiticDiseases,UnitedStatesofAmerica
Audrey Albertini FoundationforInnovativeNewDiagnostics(FIND),Switzerland
Frederic Ariey InstitutPasteur,Cambodia
John Barnwell USCentersforDiseaseControlandPrevention/NationalCenterforGlobalHealth/DivisionofMalariaandParasiticDiseases,UnitedStatesofAmerica
John Bligh HospitalforTropicalDiseases,UnitedKingdomofGreatBritainandNorthernIreland
David Bell FoundationforInnovativeNewDiagnostics(FIND),Switzerland
Andrea Bosman WorldHealthOrganization/GlobalMalariaProgramme,Geneva,Switzerland
Sandra Buisson HospitalforTropicalDiseases,UnitedKingdomofGreatBritainandNorthernIreland
Debora Casandra USCentersforDiseaseControlandPrevention/NationalCenterforGlobalHealth/DivisionofMalariaandParasiticDiseases,UnitedStatesofAmerica
Qin Cheng ArmyMalariaInstitute,Australia
Peter Chiodini HospitalforTropicalDiseases,UnitedKingdomofGreatBritainandNorthernIreland
Jane Cunningham TDR,SpecialProgrammeforResearchandTraininginTropicalDiseases,Switzerland
Chona Daga ResearchInstituteofTropicalMedicine,ThePhilippines
Linda Dantes WHO–RegionalOfficefortheWesternPacific,ThePhilippines
Djibrine Djalle InstitutPasteurBangui,CentralAfricanRepublic
Katie Downey USCentersforDiseaseControlandPrevention/NationalCenterforGlobalHealth/DivisionofMalariaandParasiticDiseases,UnitedStatesofAmerica
Babacar Faye UniversitéCheikhAntaDIOP,Senegal
Nahla Gadalla HospitalforTropicalDiseases,UnitedKingdomofGreatBritainandNorthernIreland
Dionicia Gamboa UniversidadPeruanaCayetanoHerediaInstitutodeMedicinaTropical,Peru
Cyrus Garay ResearchInstituteofTropicalMedicine,ThePhilippines
Michelle Gatton QueenslandInstituteofMedicalResearch,Australia
Jeffrey Glenn USCentersforDiseaseControlandPrevention/NationalCenterforGlobalHealth/DivisionofMalariaandParasiticDiseases,UnitedStatesofAmerica
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012) IX
Iveth Gonzalez FoundationforInnovativeNewDiagnostics(FIND),Switzerland
Sandra Incardona FoundationforInnovativeNewDiagnostics(FIND),Switzerland
Cara Kosack MédecinsSansFrontières,TheNetherlands
Myat Phone Kyaw DepartmentofMedicalResearch,Myanmar
Jennifer Luchavez ResearchInstituteofTropicalMedicine,ThePhilippines
Lorraine Mationg ResearchInstituteofTropicalMedicine,ThePhilippines
James McCarthy QueenslandInstituteofMedicalResearch,UniversityofQueensland,Australia
Didier Menard InstitutPasteurdeMadagascar,Madagascar;InstitutPasteur,Cambodia
Claribel Murillo CentroInternacionaldeEntrenamientoeInvestigacionesMédicas(CIDEIM),Colombia
Sina Nhem InstitutPasteur/NationalMalariaCentre(CNM),Cambodia
Bernhards Ogutu KenyaMedicalResearchInstitute(KEMRI),Kenya
Pamela Onyor KenyaMedicalResearchInstitute(KEMRI),Kenya
Wellington Oyibo UniversityofLagos,Nigeria
Anita Pelecanos QueenslandInstituteofMedicalResearch,Australia
Mark Perkins FoundationforInnovativeNewDiagnostics(FIND),Switzerland
Roxanne Rees-Channer Consultant(FIND),HospitalforTropicalDiseases,UnitedKingdomofGreatBritainandNorthernIreland
Muth Sinuon NationalMalariaCentre(CNM),Cambodia
Man Somnang InstitutPasteur/NationalMalariaCentre(CNM),Cambodia
Julie Vercruysse FoundationforInnovativeNewDiagnostics(FIND),Switzerland
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 4 (2012)X
abbreViations
ACT Artemisinin-basedcombinationtherapy
AMI ArmyMalariaInstitute
CDC UnitedStatesCentersforDiseaseControlandPrevention
CLIA ClinicalLaboratoryImprovementAmendments
DFID UKDepartmentforOverseasDevelopment
FIND FoundationforInnovativeNewDiagnostics
FP False-positive
HRP2 Histidine-richprotein2
HTD HospitalforTropicalDiseases
ISO InternationalOrganizationforStandardization
PCR Polymerasechainreaction
PDS Paneldetectionscore
pLDH Plasmodiumlactatedehydrogenase
Pf Plasmodium falciparum
Pv Plasmodium vivax
Pvom Plasmodium vivax, ovale, malariae
PR Positivity rate
p/µL Parasitespermicrolitre
QA Qualityassurance
QC Qualitycontrol
QMS Qualitymanagementsystems
RDT Rapiddiagnostictest(forthepurposesofthisreport,thisreferstoimmunochromatographiclateralflowdevicesforthedetectionofmalariaparasiteantigens)
SOP StandardOperatingProcedure
TDR SpecialProgrammeforResearchandTraininginTropicalDiseasessponsoredbyUNICEF,UNDP,WorldBankandWHO
UN UnitedNations
USA UnitedStatesofAmerica
USAID UnitedStatesAgencyforInternationalDevelopment
WPRO WesternPacificRegionalOffice
WHO WorldHealthOrganization
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1Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
1. sUMMarY perforMance of Malaria rdts: WHo prodUct testing: roUnds 1–4
1.1. introductionTheWorldHealthOrganizationestimatesthathalftheworld’spopulationisatriskofmalaria,withanestimated216millionpeople(range149–274million)developingclinicalmalaria in2010(81%inAfrica),and655,000deaths(range537,000–907,000)duetomalaria(91%inAfrica,mostbeingchildren).Malariaremainsendemicin106countries,andwhileparasite-baseddiagnosisisincreasing,mostsuspectedcasesofmalariaarestillnotproperlyconfirmed,resultinginover-useofanti-malarialdrugsandpoordiseasemonitoring1.
WHOrecommendsthatmalariacasemanagementbebasedonparasite-baseddiagnosisinallcases2.Theuseofantigen-detectingrapiddiagnostictests(RDTs)formsavitalpartofthisstrategy,formingthebackboneofexpansionofaccesstomalariadiagnosisbyprovidingparasite-baseddiagnosisinareaswheregoodqualitymicroscopycannotbemaintained.ThenumberofRDTsavailable,andthescaleoftheiruse,hasrapidlyincreasedoverthepastfewyears.However,limitationsofcomparativefieldtrialsandtheheterogeneousnatureofmalariatransmissionandepidemiologyhaslimitedtheavailabilityofgoodqualityperformancedatathatnationalmalariaprogrammesrequiretomakeinformeddecisionsonprocurementandimplementation,andlimitstheabilitytoextrapolateresultsoffieldtrialstodifferentpopulationsandtimeperiods.Tothisend,in2006,theWorldHealthOrganization(WHO),SpecialProgrammeforResearchandTraininginTropicalDiseases(TDR)andtheFoundationforInnovativeNewDiagnostics(FIND)launchedanevalua-tionprogrammetoassessthecomparativeperformanceofcommerciallyavailablemalariaRDTs.Currently,thesedataareguidingprocurementdecisionswhichareinturnshiftingmarketstowardsbetter-performingtests1andhelpingtodriveoverallimprovementinthequalityofmanufacturing.TheresultsofWHOMalariaRDTProductTestinghavebeenpublishedannuallysince2009andformthebasisofprocurementcriteriaofWHO,otherUNagencies,theGlobalFundandnationalgovernments.
ThisSummarypresentsanoverviewoftheresultsofthefirstthroughfourthroundsofWHOMalariaRDTProductTestingandispublishedinconjunctionwiththereleaseofthefullreportonRound4.Theresultsofthefourroundsoftestingshouldbeconsideredasasingledataset.Separate
1 World Malaria Report 2011.Geneva,WorldHealthOrganization,20112 Guidelines for the Treatment of Malaria, Second Edition.Geneva,
WorldHealthOrganization,2010(ISBN9789241547925)
fullreportsofallroundsshouldbeconsultedforfurtherdetailonproductperformance,andontheinterpretationanduseoftheseresults.
1.2. the WHo product testing programmeTheRDTevaluationssummarizedherewereperformedasacollaborationbetweenWHO,TDR,FIND,theUSCentersforDiseaseControlandPrevention(CDC)andotherpartners3.AllcompaniesmanufacturingunderISO13485:2003QualitySystemStandardwereinvitedtosubmitalimitednumberofproducts(2–3)forevaluationundertheprogramme.Inthefirstroundoftesting,41productsfrom21manufacturerswereevaluatedagainstpreparedbloodpanelsofculturedPlasmodium falciparumparasites,while29,50and48productsfrom13,23and27manufacturerswereevaluatedinRound2,3and4,respectively.Manymanufacturershavedecidedtovoluntarilyre-submitproductstooneormoreroundsoftesting,including1,23and13resubmissionsinRound2,3and4,respectively(TableS3).Ofthese168totalproducts,164progressedtotestingagainstpanelsofpatient-derivedP. falciparumandP. vivaxparasites,andaparasite-negativepanel.Thermalstabilitywasassessedaftertwomonthsofstorageatelevatedtemperatureandhumidity,andadescriptiveease-of-useassessmentwasrecorded.Ofthe164fullyevaluatedproducts,21havebeenevaluatedtwice,and8havebeenevaluatedthreetimesbetweenRounds1-4.Ofthe128uniqueproductstestedbytheprogramme,35detectP. falciparumalone,83detectanddifferentiateP. falciparumfromnon-P. falciparummalaria(eitherpan-specificorspecies-specific(Pv,Pvom),9detectP. falciparumandnon-P. falciparummalariawithoutdistinguishingbetweenthem,andoneproductwasdesignedtodetectP. vivaxonly.Manufacturerssubmittedtwolotsofeachproductforevaluation.Wherethesameproducts4havebeenre-submittedinsubsequentroundsoftesting,thelatterresultsreplacethosepublishedfromtheearlierround.Thus,theperformanceofmanytestsintheresultsbelowdifferfromthosepublishedintheRounds1–3reports.
Theevaluationisdesignedtoprovidecomparativedataontheperformanceofthesubmittedproductionlotsofeachproduct.SuchdatawillbeusedtoguideprocurementdecisionsofWHOandotherUNagenciesandnationalgovernments.
3 SeefullreportsofRounds1–4forfulllistofcollaboratingpartners.4 Informal Consultation on Laboratory Methods for Quality Assurance
of Malaria Rapid Diagnostic Tests.20-22July2004.Manila.WHORegionalOfficefortheWesternPacific.2004.(RS/2004/GE/26(PHL)
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2 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
ProducttestingispartofacontinuingprogrammeofworktoimprovethequalityofRDTsthatareused,andtosupportbroadimplementationofreliablemalariadiagnosisinareaswheremalariaisprevalent.AfifthroundofproducttestingwillbegininJanuary2013.
1.3. results of the evaluationTheresults(summarizedinFiguresS1andS2andTablesS1andS2)providecomparativedataontwolotsofproductsagainstapanelofparasitesamplesdilutedtoalowparasitedensity(200parasites/µl)andahigherparasitedensity(2000or5000parasites/µl).Theformeriswellbelowthemeanparasitedensityfoundinmanypopulationswithendemicmalaria,andconsideredclosetothethresholdthattestsmustdetecttoreliablyidentifyclinicalmalariainmanysettings1.Forthepurposesofthisreport,themainmeasureofperform-anceisthe‘paneldetectionscore(PDS)’2;thepercentageofmalariasamplesinthepanelgivingapositiveresultbytwoRDTsperlotatthelowerparasitedensity,andasingleRDTperlotatthehigherparasitedensity.Thus,itisnotameasureofRDTclinicalsensitivity,orpositivityrateagainstthepanelbutratheracombinedmeasureofpositivityrate,alongwithinter-testandinter-lotconsistency.Thefiguresalsoshowthefalse-positiveratesagainstbloodsamplescontainingnomalariaparasitesorknownmarkersofotherdiseases,andtherateatwhichinvalidresultsoccurred.
TheclinicalsensitivityofaRDTtodetectmalariaishighlydependentonthelocalconditions,includingparasitedensityinthetargetpopulation.Sensitivityofatestwillthereforevaryamongpopulationswithdifferinglevelsoftransmis-sion,astheirdifferentlevelsofimmunityaffectthepara-sitedensityatwhichtheyexhibitsymptomswarrantingadiagnostictest.Wheretransmissionratesarelow,parasitedensitiesinpeoplewithsymptomsofmalariaarelikelytobelower,resultingintestshavingalowersensitivity.Forthisreason,testperformanceat200parasites/µlisparticularlyimportant.TheresultsinthisreportshowcomparativeperformanceamongRDTs,andgiveanindicationofwhichproductsarelikelytoprovidehighersensitivityinthefield,particularlyinpopulationswithlow-densityinfections.
Ingeneral,ascountriesreducemalariaprevalenceandevenmovetowardsmalariaelimination,detectionoflowparasitedensitiesbecomesincreasinglyimportantincasemanage-ment.Asthedetectionrateat2000parasites/µlindicates,thesensitivityofmanyoftheseproductswillbesimilarinpopulationswithhigherparasitedensities,althoughasubsetofanypopulationwillincludevulnerableindividualswhomaydevelopillnessatlowparasitedensities(e.g.youngchildren,pregnantwomen,thosewellprotectedbybednets)andmustalwaysbetakenintoaccountwheninterpretingRDTresults.AnimportantcaveatwhenpredictingfieldsensitivityfromthePDSprovidedinthisreportisthatthepanelsusedinthis
1 Parasitological Confirmation of Malaria Diagnosis. ReportofaWHOtechnicalconsultationGeneva,6–8October2009. Geneva,WorldHealthOrganization,2010.(ISBN9789241599412)
2 Termed‘DetectionRate’inthefullreportofRound1,publishedin2009.SeetheRound4reportforafullexplanationofthepaneldetectionscore(PDS).
evaluationonlyincludeparasitesknowntoexpressthetargetantigens.Whilenon-expressionofthetargetantigenshasnotbeenrecordedforaldolaseorpLDH,itisknownthatparasitesinfectingpeopleinsomeareasofSouthAmericadonotexpressHRP23.InareaswhereHRP2-deletedparasitesexist,HRP2-detectingtestswillhavegreatlyreducedsensitivityorbeincapableofdetectingP. falciparum.Insuchpopulations,onlytestsdetectingpLDHinP. falciparumparasiteswillbeeffectiveindiagnosingfalciparummalaria.
Heatstability(summarizedinTableS2)isvitaltomaintainingsensitivityofthetestinthefield.Asaresult,forprocurement,itisessentialthatcarefulconsiderationbegiventostabilityresultstoensurethatproductstobeusedinareaswithhightemperaturesoftransportandstoragehavedemonstratedstabilityintheproducttestingprogramme.Requirementswillvarybetweencountries:forexample,iftestsaretobedeployedinareaswheretemperaturesrarelyriseabove30°C,lessemphasismaybeplacedonstabilityathightemperaturescomparedtootheraspectsoftestquality.
Ease-of-userequirementswillalsovary,dependingontheextentoftrainingandtheworkenvironmentoftheend-users.Particularlyinprimaryhealthcaresettings,thesimplerthetests,theeasieritwillbetoavoiderrorsinpreparationandinterpretation.
Detailedresultsoftheevaluationscanbefoundinthereportsofeachevaluation,4andatwww.wpro.who.int/sites/rdt.WHOprovidesguidanceontheprocurementandimplementationofmalariaRDTs5,6.Furthermore,aninteractiveguidetoassistinselectingproductswithperformancecharacteristicsmostsuitableforaparticularcountryhealthprogrammeisfoundontheFINDwebsite.7
3 Gamboa,D.,M.F.Ho,etal. 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 1 (2008).Geneva,WorldHealthOrganization,2009.ISBN9789241598071;Malaria Rapid Diagnostic Test Performance : Results of WHO product testing of malaria RDTs: Round 2 (2009). Geneva,WorldHealthOrganization,2010.ISBN9789241599467;Malaria Rapid Diagnostic Test Performance : Results of WHO product testing of malaria RDTs: Round 3 (2010-11).Geneva,WorldHealthOrganization,2011.ISBN9789241502566.
5 Good practices for selecting and procuring rapid diagnostic tests for malaria.Geneva,WorldHealthOrganization , 2011(ISBN9789241501125)
6 Universal Access to Malaria Diagnostic Testing: An operational manual.Geneva,WorldHealthOrganization,2011(ISBN978924150209)
7 MalariaRDTInteractiveGuide:http://www.finddiagnostics.org/programs/malaria-afs/malaria/rdt_quality_control/product_testing/interactive-guide/index.jsp
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3Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
1.4. summary of outcomesThislaboratory-basedevaluationprovidesacomparativemeasureofRDTperformanceinastandardizedwaytodistinguishbetweenwellandpoorlyperformingteststoinformprocurementdecisionsofmalariacontrolprogrammesandguideUNprocurementpolicy.
Overall,thegainsnotedintheperformanceofproductsre-submittedtoRound3wereseenagaininRound4forseveralproducts(TableS3),indicatingproductimprovementbythemanufacturers.Furthermore,inRound4thepropor-tionoftestsachievingaPDS(>75%)at200parasites/µliscomparabletoRound3forP. falciparumat73.9%andforP. vivax,theproportionis47.2%,representinganimprove-mentoverRounds1and3combined(36.7%).
SeveralRDTsfromthefourroundsoftestingdemonstratedconsistentdetectionofmalariaatlowparasitedensities(200parasites/µl),havelowfalse-positiverates,arestableattropicaltemperatures,arerelativelyeasytouse,andcandetectP. falciparum,P. vivaxinfections,orboth.
Performanceamongproductsvariedwidelyatlowparasitedensity(200parasites/µl);however,themajorityofproductsshowedahighlevelofdetectionat2000or5000parasites/µl.
P. falciparumteststargetingHRP2antigendemonstratedthehighestdetectionrates.InRound4,bothteststargetingpf-pLDHfordetectionofP. falciparuminfectiondidnotpassPhase1.Thus,therangeofchoiceforwell-performingpLDHbasedP. falciparumtestsremainslimited,asitdoesforpan-onlyspecifictests.
Testperformancesometimesvariedbetweenlots,andwidelybetweensimilarproducts,confirmingtheadvisabilityoflot-testingpost-purchaseandpriortouseinthefield.
Theresultsunderscoretheneedformanufacturerstohaveadequatereferencematerialsforproductdevelopmentandlot-release.TheWHO-FINDMalariaRDTEvaluationProgramme,incollaborationwiththeCDC,offersqualitystandardpanelsofP. falciparumisolatestomanufacturerstoassistinthisprocessandisplanningtotransitiontomalariarecombinantantigenspanelsbytheendof2014.
1.5. Use of these resultsAccuratediagnosisisvitaltogoodmalariacasemanagement,whetherbasedonmicroscopyorRDTs.Theresultsofthisreportshouldbeusedtoshort-listRDTsforprocurementforuseinsettingswheregoodmicroscopyisnotavailableorappropriate.Additionally,itisimperativethatprocurementdecisionsbasedontheseresultstakeintoconsiderationlocalconditionsofmalariatransmissionandillnesswherethetestswillbeused(e.g.Plasmodiumspecies,targetantigenvaria-tion,parasitedensities,climate),aswellasotherimportantconsiderations,includingfield-basedease-of-useassess-ments,andtraining/retrainingrequirements.Furthermore,inordertoensurethatthehighperformancedemonstratedbythelotsevaluatedintheproducttestingprogrammeismaintained,itisrecommendedthateachlotofRDTsisalsotestedinastandardizedwaypriortodispersaltothefield1.ProcurementofRDTsmustnotoccurwithoutprogrammaticandinfrastructurepreparationforproperuse,includingsupplychainmanagement,trainingontestusageanddisposal,andtrainingonpatientmanagementinresponsetoresults.Themainreportprovidesanalgorithm(Annex5a)toassistinthisdecision-makingprocessandcomprehensiveguidanceonseveralaspectsofprocurementcanbefoundin‘Good Practices for selecting and procuring rapid diagnostic tests for malaria’2.
1 TheWHO-FINDMalariaRDTEvaluationProgrammeprovideslot-testingcapacityinanumberofregionallaboratoriesfreeofcharge,[email protected]@finddiagnostics.org.
2 Good Practices for selecting and procuring rapid diagnostic tests for malaria, Geneva, World Health Organization, 2011(ISBN9789241501125)
mailto:Malaria_rdt%40who.int?subject=mailto:info%40finddiagnostics.org?subject=
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4 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Figure S1: Malaria RDT performance in Phase 2 of Rounds 1-4 against wild type (clinical) samples containing P. falciparum at low (200) and high (2000–5000) parasite densities (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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sUM
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5Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Figure S1: Malaria RDT performance in Phase 2 of Rounds 1-4 against wild type (clinical) samples containing P. falciparum at low (200) and high (2000–5000) parasite densities (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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6 Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Figure S2: Malaria RDT performance in Phase 2 of Rounds 1-4 against wild type (clinical) samples containing P. vivax at low (200) and high (2000–5000) parasite densities (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.
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DH
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ard
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29
23
Par
aban
k™ D
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Rap
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est
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aria
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5
03
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02
5F
irst
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n™
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iew
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tal V
er.
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ick)
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IND
ON
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TE
P M
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AR
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IGE
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an T
ES
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35
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ICT
Dia
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ML
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re™
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AL
-19
00
22
Mal
asca
n™
Dev
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apid
tes
t fo
r M
alar
ia P
f/P
an
50
40
20
25
dia
gn
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MA
LA
RIA
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sett
e M
PN
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7.3
dia
gn
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MA
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asse
tte
MP
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WB
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7.4
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ick
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est
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6-2
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lear
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ual
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t D
evic
e V
B2
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KM
VF
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00
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irst
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n™
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araV
iew
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alar
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est
21
03
CB
-25
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amax
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apid
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t fo
r M
alar
ia P
an/P
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evic
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03
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02
5Tr
ust
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test
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22
On
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alar
ia T
est
53
7-2
5-D
BA
dva
nta
ge
Mal
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IR2
11
02
5Im
mu
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ick
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05
06
_K2
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ore
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aria
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Pf
MA
L-1
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02
4P
aras
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apid
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or
Mal
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50
31
00
25
IMM
UN
OQ
UIC
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ON
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T M
AL
AR
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4
05
25
K2
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iSen
s M
alar
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g P
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.v C
ard
H
R2
82
3E
zDx™
Mal
aria
Pan
/Pf
Rap
id T
est
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kit
RK
MA
L 0
01
Co
re™
M
alar
ia P
an/P
v/P
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AL
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26
dia
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MP
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tal (
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stic
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66
00
50
Nan
oS
ign
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RM
AD
10
AB
ON
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lus
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id T
est
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ole
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alar
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om
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/ P
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-pL
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t D
evic
e
MF
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24
Cle
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mb
o V
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alar
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AN
GM
00
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alar
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f (H
RP
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PA
N (
pL
DH
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nti
gen
Det
ecti
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Tes
t D
evic
e 1
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iPro
Mal
aria
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HR
P2
/pL
DH
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mb
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R-0
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Su
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y M
alar
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an R
apid
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MA
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pf
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tig
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etec
tio
n T
est
Dev
ice
M
FV
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On
e S
tep
Mal
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Tes
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asse
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52
33
52
AZ
OG
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aria
pf
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AN
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tig
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etec
tio
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e M
FV
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stS
ign
™ -
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aVie
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d T
est
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02
CB
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Mal
eris
can
® M
alar
ia P
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AN
(P
v, P
m,
Po
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e A
nti
gen
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t M
AT-
PF
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N-5
0A
BO
N M
alar
ia P
an/P
.f.
Rap
id T
est
Dev
ice
IM
A-B
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aler
isca
n®
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MA
T-5
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ne
Ste
p M
alar
ia A
nti
gen
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ip 8
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uic
ksti
ck M
alar
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nti
gen
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ZO
G
hC
G M
alar
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etec
tio
n T
est
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ice
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Par
ahit
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tal D
evic
e R
apid
tes
t fo
r P.
fal
cip
aru
m a
nd
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mal
aria
l sp
ecie
s. 2
59
89
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ago
n M
alar
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om
bi 5
80
24
Mal
aria
Pan
Tes
t M
AL
-W2
3N
-00
1M
alar
ia P
.F/V
ivax
17
21
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P-2
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alar
ia p
f (H
RP
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/ p
v (p
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An
tig
en D
etec
tio
n T
est
Dev
ice
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3-1
01
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alar
ia p
f (H
RP
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/ p
v (p
LD
H)
An
tig
en D
etec
tio
n T
est
Dev
ice
MF
V-1
24
VM
alar
ia P
f/P
v G
M0
02
Ad
van
ced
Qu
alit
y™
On
e S
tep
Mal
aria
P.f
/P.v
Tri
-Lin
e Te
st
ITP
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00
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C4
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um
asis
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aria
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/Pan
An
tig
en T
est
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AL
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25
-
sUM
Mar
Y r
oU
nd
s 1-
4
7Malaria rapid diagnostic test perforMance – summary results of WHo product testing of malaria rdts: round 1-4 (2008-2012)
Figure S2: Malaria RDT performance in Phase 2 of Rounds 1-4 against wild type (clinical) samples containing P. vivax at low (200) and high (2000–5000) parasite densities (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.
Hu
mas
is M
alar
ia P
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.v A
nti
gen
Tes
t A
MF
V-7
02
5O
nS
ite
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Ag
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id T
est
R0
11
2C
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van
tag
e P
an M
alar
ia C
ard
IR
01
30
25
Ad
van
tag
e M
al C
ard
IR
22
10
25
Car
eSta
rt™
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aria
pL
DH
(P
AN
) G
01
11
SD
BIO
LIN
E M
alar
ia A
g
05
FK
40
SD
BIO
LIN
E M
alar
ia A
g P
.f/P
an
05
FK
60
BIO
NO
TE
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.& P
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Ag
Rap
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est
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R
G1
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pti
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L-I
T
71
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24
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10
SD
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E M
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™
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gn
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OM
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edis
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alar
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MB
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16
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are
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BO
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16
1S
D B
IOL
INE
Mal
aria
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Pf/
Pan
05
FK
66
Fir
st R
esp
on
se®
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aria
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pL
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I1
2F
RC
30
SD
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E M
alar
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g P
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5F
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™ M
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12
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™ M
alar
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alar
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71
Car
eSta
rt™
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aria
HR
P2
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f/P
AN
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BO
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13
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areS
tart
™ M
alar
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cree
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GO
23
1B
ION
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E M
AL
AR
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.f.&
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Rap
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est
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Rap
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est
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