Malaria Rapid Diagnostic Test Performance Results of WHO product testing of malaria RDTs: Round 3 (2010-2011)
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Mala
ria R
apid
Diag
nost
ic Te
st Pe
rform
ance
Re
sults
of W
HO p
rodu
ct te
sting
of m
alaria
RDT
s: Ro
und
3 (2
010-
2011
)
Malaria Rapid Diagnostic Test Performance
Results of WHO product testing of malaria RDTs: Round 3 (2010-2011)
Malaria Rapid Diagnostic Test Performance
Results of WHO product testing of malaria RDTs: Round 3 (2010-2011)
WHO Library Cataloguing-in-Publication Data :Malaria rapid diagnostic test performance results of WHO product testing of malaria RDTs: round 3 (2010-2011).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 150256 6 (NLM classification: WC 750)
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) I I I
Contents acknoWledgeMents Viii
abbreViations X
1. sUMMarY perforMance of Malaria rdts: WHo prodUct testing: roUnds 1-3 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 3 eXecUtiVe sUMMarY 132.1. introduction 132.2. the WHo product testing programme 132.3. results of the evaluation 132.4. Use of these results 14
3. backgroUnd 15
4. objectiVe 16
5. Materials and MetHods 175.1. test selection 175.2. outline of the product testing protocol 175.3. evaluation panels 195.4. rdt registration 205.5. specimen panel registration 205.6. test phases 205.7. performing rapid tests 205.8. interpretation of results 20
6. data ManageMent 21
7. QUalitY assUrance 22
8. etHical considerations 22
9. data analYsis 239.1. Measures of parasite detection: panel detection score
and positivity rates 239.2. false-positive results 23
9.2.1. incorrect species identification 239.2.2. false-positives from plasmodium-negative samples 23
9.3. band intensity 239.4. lot agreement 239.5. invalid tests 239.6. Heat (thermal) stability 24
10. laboratorY VersUs field-based Malaria rdt eValUations 24
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)IV
11. resUlts 2511.1. summary 2511.2. phase 1 - p. falciparum culture panel 3011.3. phase 2 - Wild-type p. falciparum and p. vivax and
plasmodium spp. negative samples 3111.3.1. p. falciparum detection 3111.3.2. p. vivax detection 3211.3.3. combined detection of p. falciparum and p. vivax 3311.3.4. p. falciparum and p. vivax positivity rate 3311.3.5. band intensity 3411.3.6. false-positive rates 35
12. Heat stabilitY 3712.1. p. falciparum test lines 4012.2. pan-specific test lines 43
13. ease of Use description 45
14. discUssion of keY findings 4914.1. panel detection score (pds) and its relationship
to sensitivity 4914.2. false-positive rate and specificity 5014.3. Heat (thermal) stability 5014.4. ease of use description 5114.5. inter-lot variability 5114.6. target antigens and species 52
15. Using tHese resUlts to ensUre QUalitY of diagnosis in tHe field 5215.1. beyond procurement 5215.2. lot testing 53
16. conclUsions 53
17. references 54
anneXes 55annex 1: characteristics of rapid malaria tests
in round 3 56annex 2: Malaria rdt guide to results interpretation 58annex 3: phase 1 results 70annex 4: phase 2 results 74annex 5a: selection of an appropriate rdt 104annex 5b: rdt format review and ease
of use assessment 105annex 6: introducing rdt-based malaria diagnosis
into national programmes 106
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 3 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.
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) V
figUres
Figure S1: MalariaRDTperformanceinPhase2ofRounds1-3againstwild-type(clinical)samplescontainingP. falciparum atlow(200)andhigh(2000or5000)parasitedensities(parasites/µl)andclean-negativesamples
Figure S2: MalariaRDTperformanceinPhase2ofRounds1-3againstwild-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 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 A6.1: ExamplemalariaRDTimplementationbudget
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)VI
tables
Table S1: MalariaRDTPhase2performanceinRounds1-3againstwild-type(clinical)samplescontainingP. falciparum and P. vivax atlow(200)andhigh(2000or5000)parasitedensities(parasites/µl)andclean-negativesamples
Table S2: MalariaRDTRounds1-3heatstabilityresultsonacultured P. falciparum sampleatlow(200)andhigh(2000)parasitedensity(parasites/µl).Positivityrateatbaseline,andafter60daysincubationat35°Cand45°C
Table S3: Productresubmissions:WHOMalariaRDTProductTesting(Rounds1-3)
Table 1: ManufacturersandproductsacceptedintoRound3ofWHOMalariaRDTProductTestingProgramme
Table 2: CharacteristicsofPlasmodiumspp.negativespecimens
Table 3: SummaryPhase1performanceof50malariaRDTsagainst20culturedP. falciparumlinesatlow(200)andhigh(2000)parasitedensities(parasites/µl)
Table 4: SummaryPhase2performanceof50malariaRDTsagainstwild-type(clinical)P. falciparumandP. vivaxsamplesatlow(200)andhigh(2000)parasitedensities(parasites/µl)andPlasmodiumspp.negativesamples
Table 5: Heatstabilitytestingresultsfor50malariaRDTsonaculturedP. falciparumsampleatlow(200)andhigh(2000)parasitedensities(parasites/µl).Positivityrateatbaseline,andafter60daysincubationat35°Cand45°C
Table 6: Easeofusedescriptionof50malariaRDTs
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-positiverateforwild-typeP. falciparumtestlineresultsonallmalaria-negativesamples
Table A4.8: Phase2false-positiverateforP. falciparuminsamplescontainingspecificnon-malarialinfectiouspathogens
Table A4.9: Phase2false-positiverateofP. falciparuminsamplescontainingpotentiallycross-reactingbloodimmuno-logicalfactors
Table A4.10: Phase2false-positiverateofpan/P. vivaxtestlineresultsonallmalaria-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
Table A4.12: HeatstabilitytestingresultsforP. falciparum(orpan)testlineonaP. falciparumsampleathighparasitedensity(2000parasites/µl).Positivityrateatbaseline,andafter60daysincubationat4°C,35°Cand45°C
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) VII
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
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)VIII
acknoWledgeMents
TheevaluationdescribedinthisreportwasajointprojectoftheGlobalMalariaProgramme(GMP),theFoundationforInnovativeNewDiagnostics(FIND),TDR,SpecialProgrammeforResearchandTraininginTropicalDiseasessponsoredbyUNICEF,UNDP,WorldBankandWHOandtheUSCentersforDiseaseControlandPrevention(CDC),undertheWHO-FINDMalariaRDTEvaluationProgramme.TheprojectwasfinancedbyFIND,theAustralianAgencyforInternationalDevelopment(AusAID),theUnitedStatesAgencyforInternationalDevelopment(USAID),theUKDepartmentforInternationalDevelopment(DFID)andTDR.Theprojectwouldnothavebeenpossiblewithoutthecooperationandsupportofthespecimencollectionsites,andthespecimencharacterizationlaboratoriesmentionedherein,andacknowledgesthetechnicaladvicefrommanymalariadiagnosticmanufacturersanddevelopersinthedevelopmentoftheprogramme.ThisreportonRound3ofWHOMalariaRDTProductTestingwascompiledbyJaneCunningham(SpecialProgrammeforResearchandTraininginTropicalDiseases(TDR),Switzerland)andDavidBell(FoundationforInnovativeNewDiagnostics(FIND),Switzerland)
TheMalariaRDTEvaluationProgrammeofWHO,TDRandFINDisgratefultoallthosewhocontributedtotheconductoftheevaluationandpreparationofthisRound3report.
Salim Abdullah IfakaraHealthResearchandDevelopmentCentre,UnitedRepublicofTanzania
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
Linda Dantes WHO–RegionalOfficefortheWesternPacific,ThePhilippines
Djibrine Djalle InstitutPasteurBangui,CentralAfricanRepublic
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
Iveth Gonzalez FoundationforInnovativeNewDiagnostics(FIND),Switzerland
Sandra Incardona FoundationforInnovativeNewDiagnostics(FIND),Switzerland
Sophie Jones USCentersforDiseaseControlandPrevention/NationalCenterforGlobalHealth/DivisionofMalariaandParasiticDiseases,UnitedStatesofAmerica
Cara Kosack MédecinsSansFrontières,TheNetherlands
Myat Phone Kyaw DepartmentofMedicalResearch,Myanamar
Jennifer Luchavez ResearchInstituteofTropicalMedicine,ThePhilippines
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) IX
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
Daniel Orozco MédecinsSansFrontières,TheNetherlands
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
Michael Valentine USCentersforDiseaseControlandPrevention/NationalCenterforGlobalHealth/DivisionofMalariaandParasiticDiseases,UnitedStatesofAmerica
Melissa Vega TDR,SpecialProgrammeforResearchandTraininginTropicalDiseases,Switzerland
Julie Vercruysse FoundationforInnovativeNewDiagnostics(FIND),Switzerland
Kristin Wall USCentersforDiseaseControlandPrevention/NationalCenterforGlobalHealth/DivisionofMalariaandParasiticDiseases,UnitedStatesofAmerica
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)X
abbreViations
ACT Artemisinin-basedcombinationtherapy
AMI ArmyMalariaInstitute
AusAID AustralianAgencyforInternationalDevelopment
CDC UnitedStatesCentersforDiseaseControlandPrevention
CLIA ClinicalLaboratoryImprovementAmendments
DFID UKDepartmentforOverseasDevelopment
FIND FoundationforInnovativeNewDiagnostics
HRP2 Histidine-richprotein2
HTD HospitalforTropicalDiseases
ISO InternationalOrganizationforStandardization
PCR Polymerasechainreaction
PDS Paneldetectionscore
pLDH Plasmodiumlactatedehydrogenase
Pf Plasmodium falciparum
Pv Plasmodium vivax
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
sUM
Mar
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oU
nd
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3
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 1
1. sUMMarY perforMance of Malaria rdts: WHo prodUct testing: roUnds 1-3
1.1. introductionTheWorldHealthOrganizationestimatesthathalftheworld’spopulationareatriskofmalaria,with225millionpeopledevelopingclinicalmalariain2009(78%inAfrica),and781,000deaths(91%inAfrica,mostbeingchildren).Malariaremainsendemicin106countries,andwhileparasite-baseddiagnosisisincreasing,mostsuspectedcasesofmalariaarestillnotproperlyidentified,resultinginover-useofanti-malarialdrugsandpoordiseasemonitoring.1
WHOrecommendsthatmalariacasemanagementbebasedonparasite-baseddiagnosisinallcases2.Theuseofantigen-detectingrapiddiagnostictests(RDTs)formsavitalpartofthisstrategy,formingthebackboneofexpansionofaccesstomalariadiagnosisastheyprovideparasite-baseddiagnosisinareaswheregoodqualitymicroscopycannotbemaintained.ThenumberofRDTsavailable,andthescaleoftheiruse,hasrapidlyincreasedoverthepastfewyears.However,limitationsofcomparativefieldtrialsandtheheterogeneousnatureofmalariatransmissionandepidemiologyhaslimitedtheavailabilityofgoodqualityperformancedatathatnationalmalariaprogrammesrequiretomakeinformeddecisionsonprocurementandimplementation,andlimitstheabilitytoextrapolateresultsoffieldtrialstodifferentpopulationsandtimeperiods.Tothisendin2006,theWorldHealthOrganization(WHO),SpecialProgrammeforResearchandTraininginTropicalDiseases(TDR)andtheFoundationforInnovativeNewDiagnostics(FIND)launchedanevalua-tionprogrammetoassessthecomparativeperformanceofcommerciallyavailablemalariaRDTs.Thisdataisguidingprocurementdecisionsandhelpingtodriveimprovementinthequalityofmanufacturing.TheresultsofthefirstandsecondroundsofProductTestingwerepublishedin2009and2010,andnowformthebasisofprocurementcriteriaofWHOandUNagenciesandnationalgovernments.
ThisSummarypresentsanoverviewoftheresultsofthefirst,secondandthirdroundsofWHOProductTestingofmalariaantigen-detectingRDTscompletedin2008,2009and2011respectively,andispublishedinconjunctionwiththereleaseoftheresultsofRound3.Theresultsofthethreeroundsoftestingshouldbeconsideredasasingledataset.Concerningproductsre-submittedforevaluation,theresultsofearlierroundsarereplacedbysubsequentroundsandthereforeonlyonesetofresultsperproductfeaturein
1 World Malaria Report 2010.Geneva,WorldHealthOrganization,2010.2 Guidelines for the Treatment of Malaria, Second Edition.Geneva,
WorldHealthOrganization,2010.
thissummary.Separatefullreportsofallroundsshouldbeconsultedforfurtherdetailonproductperformance,andontheinterpretationanduseoftheseresults.
1.2. the WHo product testing programmeTheRDTevaluationssummarizedherewereperformedasacollaborationbetweenWHO,TDR,FIND,theUSCentersforDiseaseControlandPrevention(CDC)andotherpartners3.AllcompaniesmanufacturingunderISO13485:2003QualitySystemStandardwereinvitedtosubmitupto3testsforevaluationundertheprogramme.Inthefirstroundoftesting,41productsfrom21manufacturerswereevaluatedagainstpreparedbloodpanelsofculturedPlasmodium falciparumparasites,while29productsfrom13manufacturerswereevaluatedinRound2.InRound3,50productswereevaluatedfrom23manufacturers,including23productsre-submittedfromearlierrounds(TableS3).Ofthese120totalproducts,118progressedtotestingagainstpanelsofpatient-derivedP. falciparumandP. vivaxparasites,andaparasite-negativepanel.Thermalstabilitywasassessedaftertwomonthsofstorageatelevatedtemperatureandhumidity,andadescriptiveeaseofuseassessmentwasrecorded.Ofthe118fullyevaluatedproducts,25havebeenevaluatedinmorethanoneround.Ofthe95uniqueproductstestedbytheprogramme,29detectP. falciparumalone,57detectanddifferentiateP. falciparumfromnon-P. falciparummalaria(eitherpan-specificorspecies-specific),8detectP. falciparumandnon-P. falciparummalariawithoutdistinguishingbetweenthem,andoneproductwasdesignedtodetectP. vivaxonly.Manufacturerssubmittedtwolotsofeachproductforevaluation.Wherethesameproducts4havebeenre-submittedinsubsequentroundsoftesting,thelatterresultsreplaceresultspublishedfromtheearlierround.Thus,theperformanceofmanytestsintheresultsbelowdifferfromthosepublishedintheRound1andRound2reports.
Theevaluationisdesignedtoprovidecomparativedataontheperformanceofthesubmittedproductionlotsofeachproduct.SuchdatawillbeusedtoguideprocurementdecisionsofWHOandotherUNagenciesandnationalgovernments.ProducttestingispartofacontinuingprogrammeofworktoimprovethequalityofRDTsthatareused,andtosupportbroadimple-mentationofreliablemalariadiagnosisinareaswheremalariaisprevalent.AfourthroundofproducttestingbeganinJune2011.
3 SeefullreportsofRounds1,2and3forfulllistofcollaboratingpartners.4 Workingdefinitionofaproductcanbefoundhereonpage13:http://
www.wpro.who.int/internet/resources.ashx/RDT/docs/pdf_version/web3_QARDTreport.pdf(accessed8September2011)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)2
1.3. results of the evaluationTheresults(summarizedinFiguresS1andS2andTablesS1andS2)providecomparativedataontwolotsofproductsagainstapanelofparasitesamplesdilutedtoalowparasitedensity(200parasites/µl)andahigherparasitedensity(2000or5000parasites/µl).Theformeriswellbelowthemeanparasitedensityfoundinmanypopulationswithendemicmalaria,andconsideredclosetothethresholdthattestsmustdetecttoreliablyidentifyclinicalmalariainmanysettings.5Forthepurposesofthisreport,themainmeasureofperform-anceisthe‘paneldetectionscore(PDS)’6;thepercentageofmalariasamplesinthepanelgivingapositiveresultbytwoRDTsperlotatthelowerparasitedensity,andasingleRDTperlotatthehigherparasitedensity.Thus,itisnotameasureofRDTclinicalsensitivity,orpositivityrateagainstthepanelbutratheracombinedmeasureofpositivityrate,alongwithinter-testandinter-lotconsistency.Thefiguresalsoshowthefalse-positiveratesagainstbloodsamplescontainingnomalariaparasitesorknownmarkersofotherdiseases,andtherateatwhichinvalidresultsoccurred.
TheclinicalsensitivityofanRDTtodetectmalariaishighlydependentonthelocalconditions,includingparasitedensityinthetargetpopulation.Sensitivityofatestwillthereforedifferbetweenpopulationswithdifferinglevelsoftransmission,astheirdifferentlevelofimmunitywillaffecttheparasitedensityatwhichtheyexhibitsymptomswarrantingadiagnostictest.Wheretransmissionratesarelow,parasitedensitiesinpeoplewithsymptomsofmalariaarelikelytobelower,resultingintestshavingalowersensitivity.Forthisreason,testperform-anceat200parasites/µlisparticularlyimportant.TheresultsinthisreportshowcomparativeperformancebetweenRDTs,andgiveanindicationofwhichproductsarelikelytoprovidehighersensitivityinthefield,particularlyinpopulationswithlow-densityinfections.Ingeneral,ascountriesreducemalariaprevalenceandevenmovetowardsmalariaelimination,detectionoflowparasitedensitiesbecomesincreasinglyimportantincasemanagement.Asthedetectionrateat2000parasites/µlindicates,thesensitivityofmanyoftheseproductswillbesimilarinpopulationswithhigherparasitedensities,althoughasubsetofanypopulationwillincludevulnerableindividualswhomaydevelopillnessatlowparasitedensities(e.g.youngchildren,pregnantwomen,thosewellprotectedbybednets)andmustalwaysbetakenintoaccountwheninterpretingRDTresults.AnimportantcaveatwhenpredictingfieldsensitivityfromthePDSprovidedinthisreportisthatthepanelsusedinthisevaluationonlyincludeparasitesknowntoexpressthetargetantigens.Whilenon-expressionofthetargetantigenshasnotbeenrecordedforaldolaseorpLDH,itisknownthatparasitesinfectingpeopleinsomeareasofSouthAmericadonotexpressHRP27.InareaswhereHRP2-deletedparasitesexist,HRP2-detecting
5 Parasitological Confirmation of Malaria Diagnosis. ReportofaWHOtechnicalconsultationGeneva,6–8October2009. Geneva,WorldHealthOrganization,2010.ISBN9789241599412
6 Termed‘DetectionRate’inthefullreportofRound1,publishedin2009.SeetheRound3reportforafullexplanationofthepaneldetectionscore(PDS).
7 GamboaDetal.PLoS One,2010:5(1):e8091
testswillhavegreatlyreducedsensitivityorbeincapableofdetectingP. falciparum.Insuchpopulations,onlytestsdetectingpLDHinP. falciparumparasiteswillbeeffectiveindiagnosingfalciparummalaria.
Heatstability(summarizedinTableS2)isvitaltomaintainingsensitivityofthetestinthefield.Asaresult,forprocurement,itisessentialthatcarefulconsiderationbegiventostabilityresultstoensurethatproductstobeusedinareaswithhightemperaturesoftransportandstoragehavedemonstratedstabilityintheproducttestingprogramme.Requirementswillvarybetweencountries:forexample,iftestsaretobedeployedinareaswheretemperaturesrarelyriseabove30°C,lessemphasismaybeplacedonstabilityathightemperaturescomparedtootheraspectsoftestquality.
Easeofuserequirementswillalsovary,dependingontheextentoftrainingandtheworkenvironmentoftheend-users.Particularlyinprimaryhealthcaresettings,thesimplerthetests,theeasieritwillbetoavoiderrorsinpreparationandinterpretation.
Detailedresultsoftheevaluationscanbefoundinthereportsofeachevaluation,8andatwww.wpro.who.int/sites/rdt.AninteractiveguidetoassistinselectingproductswithperformancecharacteristicsmostsuitableforaparticularcountryhealthprogrammeisfoundontheFINDwebsite.9
8 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
9 MalariaRDTInteractiveGuide:http://www.finddiagnostics.org/programs/malaria/find_activities/product_testing/malaria-rdt-product-testing/index.jsp(accessed8Sept.2011)
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 3
1.4. summary of outcomesThislaboratory-basedevaluationprovidesacomparativemeasureofRDTperformanceinastandardizedwaytodistinguishbetweenwellandpoorlyperformingteststoinformprocurementdecisionsofmalariacontrolprogrammesandguideUNprocurementpolicy.
Overall,animprovementwasnotedintheperformanceofproductsre-submittedtoRound3(TableS3),indicatingproductimprovementbythemanufacturers.Furthermore,theproportionoftestsachievingaPDS(>75%)at200parasites/µlishigherthanthatseeninpreviousreports.
SeveralRDTsfromthethreeroundsoftestingdemonstratedconsistentdetectionofmalariaatlowparasitedensities(200parasites/µl),havelowfalsepositiverates,arestableattropicaltemperatures,arerelativelyeasytouse,andcandetectP. falciparum,P. vivaxinfections,orboth.
Performancebetweenproductsvariedwidelyatlowparasitedensity(200parasites/µl);however,themajorityofproductsshowedahighlevelofdetectionat2000or5000parasites/µl.
P. falciparumteststargetingHRP2antigendemonstratedthehighestdetectionrates,butsometeststargetingpLDHalsoexhibitedhighdetectionrates.
Testperformancevariedbetweenlots,andwidelybetweensimilarproducts,confirmingtheadvisabilityoflot-testingpost-purchaseandpriortouseinthefield.
Theresultsunderscoretheneedformanufacturerstohaveadequatereferencematerialsforproductdevelopmentandlot-release.TheWHO-FINDMalariaRDTEvaluationProgramme,incollaborationwiththeCDC,offersqualitystandardpanelstomanufacturerstoassistinthisprocess.
1.5. Use of these resultsAccuratediagnosisisvitaltogoodmalariacasemanagement,whetherbasedonmicroscopyorRDTs.Theresultsofthisreportshouldbeusedtoshort-listRDTsforprocurementforuseincaseswheregoodmicroscopyisnotavailableorappropriate.Additionally,itisimperativethatprocurementdecisionsbasedontheseresultstakeintoconsiderationlocalconditionsofmalariatransmissionandillnesswherethetestswillbeused(e.g.Plasmodiumspecies,targetantigenvariation,parasitedensities,climate),aswellasotherimportantconsiderations,includingfield-basedeaseofuseassessments,andtraining/retrainingrequirements.Furthermore,inordertoensurethatthehighperformancedemonstratedbythelotsevaluatedintheproducttestingprogrammeismaintained,itisrecommendedthateachlotofRDTsisalsotestedinastandardizedwaypriortodispersaltothefield.10ProcurementofRDTsmustnotoccurwithoutprogrammaticandinfrastructurepreparationforproperuse,includingsupplychainmanagement,trainingontestusageanddisposal,andtrainingonpatientmanagementinresponsetoresults.Themainreportprovidesanalgorithm(Annex5a)toassistinthisdecision-makingprocessandcomprehensiveguidanceonseveralaspectsofprocurementcanbefoundin‘GoodPracticesforselectingandprocuringrapiddiagnostictestsformalaria’.11
10 TheWHO-FINDMalariaRDTEvaluationProgrammeprovideslot-testingcapacityinanumberofregionallaboratoriesfreeofcharge,[email protected]@finddiagnostics.org.
11 GoodPracticesforselectingandprocuringrapiddiagnostictestsformalaria,Geneva,WorldHealthOrganization,2011ISBN9789241501125
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)4
Figure S1: Malaria RDT performance in Phase 2 of Rounds 1-3 against wild-type (clinical) samples containing P. falciparum at low (200) and high (2000 or 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. (see Figure S2)
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 5
Figure S2: Malaria RDT performance in Phase 2 of Rounds 1-3 against wild-type (clinical) samples containing P. vivax at low (200) and high (2000 or 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.
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)6
Tabl
e S1
: Mal
aria
RDT
Pha
se 2
per
form
ance
in R
ound
s 1-
3 ag
ains
t w
ild t
ype
(clin
ical
) sa
mpl
es c
onta
inin
g P.
fal
cipa
rum
and
P. v
ivax
at
low
(20
0) a
nd
high
(20
00 o
r 50
00)
para
site
den
sitie
s (p
aras
ites
/µl)
and
clea
n ne
gati
ve s
ampl
es
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Pane
l Det
ectio
n Sc
orea
False
pos
itive
rat
es (%
)To
tal f
alse
pos
itive
ra
tesb
(%)
Inva
lid
rate
(%)
(n=1
204)
Roun
d
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
Fals
e po
sitiv
e
non-
Pf
infe
ctio
ne
Fals
e po
sitiv
e
Pf
infe
ctio
nf
Fals
e po
sitiv
e
non-
Pf
infe
ctio
ng
Fals
e po
sitiv
e
Pf
infe
ctio
nh
False
pos
itive
Pl
asm
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Infe
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Pf o
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03
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nim
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alar
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alar
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91.
00.
23
One
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Test
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37-C
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ngzh
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ondf
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 7
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Pane
l Det
ectio
n Sc
orea
False
pos
itive
rat
es (%
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alse
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(%)
Inva
lid
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para
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para
sites
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Clea
n-ne
gativ
e sa
mpl
es
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Pv samplesd
Pf samplesc
Pv samplesd
Pf s
ampl
esPv
sam
ples
Pf s
ampl
esPv
sam
ples
Fals
e po
sitiv
e
non-
Pf
infe
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ne
Fals
e po
sitiv
e
Pf
infe
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nf
Fals
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sitiv
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non-
Pf
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Fals
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Pf
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False
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nd 1
, n=1
58, R
ound
2, n
=200
; Rou
nd 3
, n=1
98)
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)
i Ro
und
1, n
=168
; Rou
nd 2
, n=2
00; R
ound
3, n
=200
j 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
re
sults
. Ref
er to
Tab
le S
3.
k PD
S pr
esen
ted
in th
e ta
ble
is b
ased
on
a po
sitiv
e pf
test
line
(eith
er p
f-H
RP2
or
pf-p
LDH
). P.
falc
ipar
um P
DS b
ased
on
indi
vidu
al te
st li
nes
was
: pf
-pLD
H (1
7.2%
at
200p
/µl;
97%
at 2
000p
/µl)
and
pf-H
RP2
(87.
9% a
t 200
p/µl
; 100
% a
t 200
0p/µ
l)
Dete
ctio
n ra
te (%
)≥9
585
-94
50-8
4<
50
Fals
e po
sitiv
e ra
te (%
)<2
2-5
6 -1
0>1
0
Inva
lid ra
te (%
)<1
% o
f tes
ts
cond
ucte
d1-
2% o
f tes
ts
cond
ucte
d2-
5% o
f tes
ts
cond
ucte
d>5
% o
f tes
ts
cond
ucte
d
Tabl
e S1
(co
ntin
ued)
sUM
Mar
Y r
oU
nd
s 1-
3
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 9
Tabl
e S2
: Mal
aria
RDT
Rou
nds
1-3
heat
sta
bilit
y re
sult
s on
a c
ultu
red
P. f
alci
paru
m s
ampl
e at
low
(20
0) a
nd h
igh
(200
0) p
aras
ite
dens
ity
(par
asit
es/µ
l).
Posi
tivi
ty r
ate
at b
asel
ine,
and
aft
er 6
0 da
ys in
cuba
tion
at 3
5°C
and
45°C
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pan
line
)Pe
rcen
t po
sitiv
e te
st r
esul
ts
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/
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
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia P
.f Te
sta
ITP1
1002
TC40
InTe
c Pr
oduc
ts, I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
N/A
N/A
3Ad
vanc
ed Q
ualit
y™M
alar
ia (p
.f) P
OCT
ITP1
1002
TC1
InTe
c Pr
oduc
ts, I
nc.
80.0
95.0
90.0
100.
010
0.0
100.
0N
/AN
/AN
/AN
/AN
/AN
/A1
Adva
ntag
e P.
f. M
alar
ia C
ard
IR01
6025
J. M
itra
& C
o. P
vt. L
td.
95.0
100.
010
0.0
100.
010
0.0
100.
0N
/AN
/AN
/AN
/AN
/AN
/A1
BION
OTE
MAL
ARIA
P.f.
Ag
Rapi
d Te
st K
it RG
19-1
1Bi
onot
e,In
c.10
0.0
100.
086
.710
0.0
90.0
80.0
N/A
N/A
N/A
N/A
N/A
N/A
3Ca
reSt
art™
Mal
aria
HRP
2 (P
f)G
0141
Acce
ss B
io, I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
N/A
N/A
1Ca
reSt
art™
Mal
aria
HRP
2/pL
DH P
f tes
tG
0181
Acce
ss B
io, I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
N/A
N/A
2Cl
earv
iew
® M
alar
ia P
.f.a
VB01
Visi
on B
iote
ch (P
ty) L
td10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
/AN
/AN
/AN
/AN
/AN
/A3
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
N/A
N/A
N/A
N/A
N/A
N/A
3di
agno
stic
ks-
Mal
aria
(Pf)
Cass
ette
KM
FC60
01SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s95
.070
.055
.095
.095
.095
.0N
/AN
/AN
/AN
/AN
/AN
/A2
diag
nost
icks
- M
alar
ia (P
f) Di
pstic
k K
MFD
6007
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
100.
010
0.0
100.
010
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
N/A
N/A
2Fi
rst R
espo
nse®
Mal
aria
Ag
HRP
2I1
3FRC
30Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
100.
010
0.0
100.
010
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
N/A
N/A
1Fi
rstS
ign™
– M
alar
ia P
f Car
d Te
st--
Uni
med
Inte
rnat
iona
l, In
c.20
.015
.00.
010
0.0
90.0
95.0
N/A
N/A
N/A
N/A
N/A
N/A
1H
exag
on M
alar
ia58
051
Hum
an G
mbH
50.0
35.0
60.0
95.0
100.
010
0.0
N/A
N/A
N/A
N/A
N/A
N/A
1H
iSen
s M
alar
ia A
g Pf
HRP
2 Ca
rd
HR3
023
HBI
Co.
, Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
/AN
/AN
/AN
/AN
/AN
/A2
ICT
Diag
nost
ics
Mal
aria
P.f.
aM
L01
ICT
Diag
nost
ics
100.
010
0.0
100.
010
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
N/A
N/A
3IM
MU
NOQ
UIC
K CO
NTA
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
unoq
uick
Mal
aria
Fal
cipa
rum
0502
_K25
Bios
ynex
100.
010
0.0
100.
010
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
N/A
N/A
1M
alar
ia P
lasm
odiu
m fa
lcip
arum
Rap
id te
st D
evic
e (W
hole
blo
od)
IMA-
402
ACON
Lab
orat
orie
s, In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
/AN
/AN
/AN
/AN
/AN
/A1
Nan
oSig
n M
alar
ia P
f Ag
RMAF
10Bi
olan
d, L
td96
.710
0.0
100.
010
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
N/A
N/A
3On
e St
ep M
alar
ia P
.F T
est (
cass
ette
)a 52
2352
Blue
Cro
ss B
io-M
edica
l (Be
ijing
) Co.
, Ltd
.63
.30.
00.
010
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
N/A
N/A
3On
e St
ep M
alar
ia P
.f Te
sta
W37
-CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
100.
093
.390
.010
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
N/A
N/A
3On
Sigh
t™ -
Mal
aria
Pf T
est
511-
25-D
BAm
geni
x In
tern
atio
nal,
Inc.
100.
095
.090
.010
0.0
100.
065
.0N
/AN
/AN
/AN
/AN
/AN
/A2
OnSi
te P
f Ag
Rapi
d Te
sta
R011
4CCT
K Bi
otec
h, In
c.96
.710
0.0
100.
010
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
N/A
N/A
3Pa
rach
eck®
Pf D
evic
e- R
apid
test
for P
. fal
cipa
rum
Mal
aria
Ver
. 3a
3030
1025
Orch
id B
iom
edic
al S
yste
ms
100.
010
0.0
100.
010
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
N/A
N/A
3Pa
rach
eck®
Pf D
ipst
ick-
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia V
er. 3
a 30
3020
25Or
chid
Bio
med
ical
Sys
tem
s10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
/AN
/AN
/AN
/AN
/AN
/A3
Para
HIT
® -
f (De
vice
)a 55
IC10
2-50
Span
Dia
gnos
tics
Ltd.
100.
096
.710
0.0
100.
010
0.0
90.0
N/A
N/A
N/A
N/A
N/A
N/A
3Pa
raH
IT®
-f (D
ipst
ick)
a 55
IC10
1-50
Span
Dia
gnos
tics
Ltd.
100.
010
0.0
56.7
100.
010
0.0
100.
0N
/AN
/AN
/AN
/AN
/AN
/A3
SD B
IOLI
NE
Mal
aria
Ag
P.f.
(HRP
2/pL
DH)b
05FK
90St
anda
rd D
iagn
ostic
s In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
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/AN
/AN
/AN
/AN
/AN
/A3
SD B
IOLI
NE
Mal
aria
Ag
Pf05
FK50
Stan
dard
Dia
gnos
tics,
Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
N/A
N/A
1Pf
and
Pan
ABON
Mal
aria
Pan
/P.f.
Rap
id T
est D
evic
e IM
A-B4
02AB
ON B
ioph
arm
(Han
gzho
u) C
o. L
td.
100.
080
.090
.010
0.0
100.
010
0.0
0.0
0.0
0.0
0.0
0.0
0.0
3Ad
vant
age
Mal
Car
dIR
2210
25J.
Mitr
a &
Co.
Pvt
. Ltd
.10
0.0
100.
055
.095
.010
0.0
95.0
55.0
45.0
40.0
100.
010
0.0
100.
01
Bina
x N
ow M
alar
ia T
est
IN66
0050
Inve
rnes
s M
edic
al In
nova
tions
, Inc
.10
0.0
100.
010
0.0
100.
010
0.0
95.0
5.0
0.0
0.0
95.0
95.0
75.0
1BI
ONOT
E M
ALAR
IA P
.f.&
Pan
Ag
Rapi
d Te
st K
it RG
19-0
8Bi
onot
e,In
c.10
0.0
100.
096
.710
0.0
100.
010
0.0
0.0
0.0
0.0
100.
010
0.0
90.0
3Ca
reSt
art™
Mal
aria
/Pre
gnan
cy C
ombo
(pLD
H/H
RP2/
HCG
) G
O221
Acce
ss B
io In
c10
0.0
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
ia H
RP2/
pLDH
(Pf/
PAN
) COM
BOG
0131
Acce
ss B
io, I
nc.
100.
095
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0.0
100.
010
0.0
100.
010
0.0
95.0
100.
010
0.0
100.
010
0.0
1Ca
reSt
art™
Mal
aria
pLD
H 3
Lin
e Te
st
GO1
21Ac
cess
Bio
, Inc
.10
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
100.
03
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)10
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pan
line
)Pe
rcen
t po
sitiv
e te
st r
esul
ts
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/
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
Care
Star
t™ M
alar
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cree
n G
O231
Acce
ss B
io, I
nc.
100.
010
0.0
93.3
100.
010
0.0
100.
010
0.0
100.
093
.310
0.0
100.
010
0.0
3Cl
earv
iew
® M
alar
ia C
ombo
a VB
11Vi
sion
Bio
tech
(Pty
) Ltd
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
90.0
20.0
0.0
3Cl
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alar
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ual T
est D
evic
ea VB
20Vi
sion
Bio
tech
(Pty
) Ltd
100.
010
0.0
96.7
100.
010
0.0
100.
00.
00.
00.
050
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.020
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diag
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MAL
ARIA
(Pan
/Pf)
Cass
ette
M
PNFW
BC10
07.4
SSA
Diag
nost
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& B
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ms
100.
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96.7
100.
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0.0
100.
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00.
00.
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0.0
90.0
90.0
3Fi
rst R
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nse®
Mal
aria
pLD
H/H
RP2
Com
bo T
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I16F
RC30
Prem
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n Lt
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0.0
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100.
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100.
010
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B-25
Uni
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l Inc
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010
0.0
100.
010
0.0
100.
095
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0.0
100.
010
0.0
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exag
on M
alar
ia C
ombi
5802
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uman
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bH65
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0.0
85.0
95.0
0.0
0.0
0.0
0.0
0.0
0.0
1H
iSen
s M
alar
ia A
g P.
f/P.
v Ca
rd
HR2
823
HBI
Co.
, Ltd
.35
.00.
05.
010
0.0
100.
010
0.0
0.0
0.0
0.0
35.0
0.0
0.0
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iSen
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alar
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ard
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923
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Co.
, Ltd
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100.
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100.
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100.
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T Di
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03
IMM
UN
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CON
TACT
MAL
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+4
0525
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ynex
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
50.0
50.0
100.
03
Imm
unoq
uick
Mal
aria
+4
0506
_K25
Bios
ynex
100.
010
0.0
100.
010
0.0
100.
010
0.0
0.0
0.0
0.0
100.
080
.080
.01
Mal
aria
P.F
/Viv
ax17
211O
P-25
Diag
nost
ics
Auto
mat
ion/
Cort
ez
Diag
nost
ics,
Inc.
65.0
15.0
20.0
65.0
45.0
5.0
0.0
0.0
0.0
0.0
0.0
0.0
1
Mal
aria
Pan
Tes
t M
AL-W
23N-
001
Dim
a •
Gese
llsch
aft f
ür D
iagn
ostik
a m
bH60
.033
.323
.310
0.0
100.
090
.013
.353
.340
.010
.060
.040
.03
Mal
aria
pf (
HRP
II) /
(PAN
-pLD
H) A
ntig
en D
etec
tion
Test
Dev
icea
MFV
-124
RAZ
OG, I
nc.
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
alar
ia p
f (pL
DH) /
PAN
-pLD
H T
est D
evic
e M
FV-1
24AZ
OG, I
nc.
3.3
0.0
0.0
40.0
10.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
3M
alas
can™
Dev
ice
- Ra
pid
test
for M
alar
ia P
f/Pa
na 50
4020
25Ze
phyr
Bio
med
ical
Sys
tem
s96
.710
0.0
96.7
100.
010
0.0
100.
00.
00.
06.
710
0.0
100.
010
0.0
3N
anoS
ign
Mal
aria
Pf/
Pan
Ag
RMAP
10Bi
olan
d, L
td10
0.0
100.
010
0.0
100.
010
0.0
90.0
0.0
0.0
0.0
0.0
0.0
0.0
3N
anoS
ign
Mal
aria
Pf/
Pv A
g RM
AD10
Biol
and,
Ltd
0.0
0.0
0.0
20.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
3On
e St
ep M
alar
ia A
ntig
en S
trip
820-
1IN
D Di
agno
stic
Inc.
15.0
0.0
0.0
65.0
50.0
0.0
15.0
0.0
0.0
65.0
50.0
5.0
1On
e St
ep M
alar
ia P
.f/Pa
n Te
sta
W56
-CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
46.7
13.3
26.7
100.
010
0.0
100.
00.
036
.773
.370
.080
.010
0.0
3On
Sigh
t™ –
Par
aQui
ck (P
an, P
f) Te
st53
6-25
DBAm
geni
x In
tern
atio
nal,
Inc.
100.
090
.060
.010
0.0
100.
010
0.0
0.0
0.0
0.0
100.
010
0.0
95.0
1On
Site
Pf/
Pan
Mal
aria
Ag
Rapi
d Te
st
R011
3CCT
K Bi
otec
h, In
c.10
0.0
100.
010
0.0
100.
010
0.0
100.
03.
366
.783
.310
0.0
100.
080
.03
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
.00.
03
Para
HIT
® to
tal (
dips
tick)
55IC
201-
10Sp
an D
iagn
ostic
s Lt
d55
.085
.055
.010
0.0
100.
095
.010
.00.
00.
050
.045
.070
.02
Para
hit-
Tota
l Dev
ice
Rapi
d te
st fo
r P. f
alci
paru
m a
nd P
an
mal
aria
l spe
cies
2598
9Sp
an D
iagn
ostic
s Lt
d.65
.075
.025
.095
.010
0.0
100.
05.
00.
00.
00.
00.
00.
01
Para
scre
en™
Dev
ice
- Ra
pid
test
for M
alar
ia P
an/P
f50
3100
25Ze
phyr
Bio
med
ical
Sys
tem
s10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
090
.010
0.0
100.
03
Quic
kstic
k M
alar
ia A
ntig
en T
est
--In
nova
tek
Med
ical
Inc.
15.0
0.0
0.0
65.0
50.0
0.0
15.0
0.0
0.0
65.0
50.0
5.0
1SD
BIO
LIN
E M
alar
ia A
g P.
f/Pa
na 05
FK60
Stan
dard
Dia
gnos
tics
Inc.
100.
096
.710
0.0
100.
010
0.0
100.
00.
00.
00.
010
0.0
70.0
90.0
3SD
BIO
LIN
E M
alar
ia A
ga 05
FK40
Stan
dard
Dia
gnos
tics
Inc.
0.0
0.0
0.0
100.
080
.090
.00.
00.
00.
080
.020
.090
.03
Sure
step
™ E
asy
Mal
aria
Pf/
Pan
Rapi
d Te
st D
evic
e IM
A-T4
02AC
ON B
iote
ch (H
angz
hou)
Co.
Ltd
.10
0.0
100.
010
0.0
100.
010
0.0
100.
00.
00.
00.
00.
00.
00.
03
Pf a
nd P
vAd
vanc
ed Q
ualit
y™ O
ne S
tep
Mal
aria
P.f/
P.v
Tri-
Line
Tes
t 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
/A3
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
N/A
N/A
N/A
N/A
N/A
N/A
3BI
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
N/A
N/A
N/A
N/A
N/A
N/A
3Ca
reSt
art™
Mal
aria
HRP
2/PL
DH (P
f/Pv
) COM
BOG
0161
Acce
ss B
io, I
nc.
100.
010
0.0
95.0
100.
010
0.0
100.
0N
/AN
/AN
/AN
/AN
/AN
/A2
Tabl
e S2
(co
ntin
ued)
sUM
Mar
Y r
oU
nd
s 1-
3
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 11
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pf
line)
Perc
ent
posit
ive
test
res
ults
fo
r P.
fal
cipa
rum
(Pan
line
)Pe
rcen
t po
sitiv
e te
st r
esul
ts
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/
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
Care
Star
t™ M
alar
ia H
RP2/
PLDH
(Pf/
VOM
) COM
BOG
0171
Acce
ss B
io, I
nc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
N/A
N/A
2Co
re™
Mal
aria
Pv/
PfM
AL-1
9002
2Co
re D
iagn
ostic
s10
0.0
100.
010
0.0
100.
010
0.0
100.
0N
/AN
/AN
/AN
/AN
/AN
/A3
diag
nost
icks
- M
alar
ia (P
v/Pf
) Cas
sett
eKM
VFC6
002
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
100.
095
.095
.010
0.0
100.
095
.0N
/AN
/AN
/AN
/AN
/AN
/A2
Falc
ivax
Rap
id T
est f
or M
alar
ia P
v/Pf
(dev
ice)
5030
0025
Zeph
yr B
iom
edic
als
100.
010
0.0
100.
010
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
N/A
N/A
2Fi
rstS
ign™
– P
araV
iew
-2 (P
v +
Pf) C
ard
Test
2102
CB-2
5U
nim
ed In
tern
atio
nal,
Inc.
95.0
70.0
0.0
100.
095
.075
.0N
/AN
/AN
/AN
/AN
/AN
/A1
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
eris
can®
Mal
aria
Pf/
Pv
MAT
-50
Bhat
Bio
-Tec
h In
dia
(P) L
td10
0.0
60.0
30.0
100.
090
.095
.0N
/AN
/AN
/AN
/AN
/AN
/A2
OnSi
ght™
- P
araQ
uick
-2 (P
v,Pf)
Mal
aria
Tes
t53
7-25
-DB
Amge
nix
Inte
rnat
iona
l, In
c.10
0.0
100.
010
0.0
100.
010
0.0
85.0
N/A
N/A
N/A
N/A
N/A
N/A
2On
Site
Mal
aria
Pf/
Pv A
g Ra
pid
Test
a R0
112C
CTK
Biot
ech,
Inc.
100.
010
0.0
100.
010
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
N/A
N/A
3SD
BIO
LIN
E M
alar
ia A
g Pf
/Pv
05FK
80St
anda
rd D
iagn
ostic
s, In
c.10
0.0
100.
010
0.0
100.
010
0.0
95.0
N/A
N/A
N/A
N/A
N/A
N/A
2Pf
, 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
3Fi
rstS
ign™
- P
araV
iew
-3 (P
an+P
v+Pf
) Mal
aria
Tes
t21
03 C
B-25
Uni
med
Inte
rnat
iona
l Inc
.10
0.0
100.
010
0.0
100.
010
0.0
100.
060
.050
.015
.010
0.0
90.0
100.
02
Para
max
-3 R
apid
Tes
t for
Mal
aria
Pan
/Pv/
Pf (d
evic
e)50
3200
25Ze
phyr
Bio
med
ical
s10
0.0
100.
010
0.0
100.
010
0.0
100.
010
0.0
25.0
30.0
100.
095
.010
0.0
2Pa
n O
nly
Adva
ntag
e Pa
n M
alar
ia C
ard
IR01
3025
J. M
itra
& C
o. P
vt. L
td.
N/A
N/A
N/A
N/A
N/A
N/A
50.0
65.0
70.0
100.
010
0.0
100.
01
Care
Star
t™ M
alar
ia p
LDH
(PAN
)G
0111
Acce
ss B
io, I
nc.
N/A
N/A
N/A
N/A
N/A
N/A
100.
010
0.0
90.0
100.
010
0.0
100.
01
Clea
rvie
w®
Mal
aria
pLD
Ha
7088
4025
Orge
nics
Ltd
. N
/AN
/AN
/AN
/AN
/AN
/A96
.793
.310
0.0
100.
010
0.0
100.
03
diag
nost
icks
MAL
ARIA
(Pan
) Cas
sett
e M
PNW
BC10
07.3
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
N/A
N/A
N/A
N/A
N/A
N/A
0.0
0.0
0.0
80.0
100.
080
.03
Firs
t Res
pons
e® M
alar
ia A
g pL
DHI1
2FRC
30Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
N/A
N/A
N/A
N/A
N/A
N/A
50.0
80.0
55.0
100.
010
0.0
100.
02
Firs
tSig
n™ -
Pan
Chec
k (P
an) M
alar
ia T
est
2104
CB-
25U
nim
ed In
tern
atio
nal I
nc.
N/A
N/A
N/A
N/A
N/A
N/A
25.0
5.0
10.0
100.
010
0.0
100.
02
OnSi
ght™
- P
anSc
reen
(Pan
) Mal
aria
Tes
t53
9-25
-DB
Amge
nix
Inte
rnat
iona
l, In
c.N
/AN
/AN
/AN
/AN
/AN
/A5.
035
.015
.010
0.0
100.
010
0.0
2Pa
raba
nk™
Dev
ice
- Ra
pid
test
for M
alar
ia P
ana
5030
1025
Zeph
yr B
iom
edic
al S
yste
ms
N/A
N/A
N/A
N/A
N/A
N/A
0.0
0.0
0.0
90.0
100.
010
0.0
3Pv
onl
ySD
BIO
LIN
E M
alar
ia A
g Pv
05FK
70St
anda
rd D
iagn
ostic
s, In
c.N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A2
Pf: P
lasm
odiu
m fa
lcip
arum
Pv
: Pla
smod
ium
viv
ax
pan:
Pla
smod
ium
spec
ies
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
S3.
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
on
200p
/µl a
nd 2
000p
/µl s
ampl
es w
ere,
resp
ectiv
ely
: pf-
pLDH
(0%
; 33.
3% d
etec
ted
at b
asel
ine
and
0% ;
33.3
% d
etec
ted
post
60
d in
cuba
tion
at 3
5°C,
45°
C) a
nd p
f-H
RP2
(100
%; 1
00%
at b
asel
ine
and
100%
; 100
% p
ost 6
0 d
incu
batio
n at
35°
C, 4
5°C)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)12
Tabl
e S3
: Pro
duct
Res
ubm
issi
ons:
WH
O M
alar
ia R
DT P
rodu
ct T
estin
g -
Roun
ds 1
-3
Man
ufac
ture
rIn
itial
Tes
ting
Subs
eque
nt T
estin
g
Roun
dPr
oduc
t N
ame
Cata
logu
e N
o Ro
und
Prod
uct
Nam
eCa
talo
gue
No
AZOG
, Inc
.1
Mal
aria
Pf (
HRP
II)/p
v-LD
H) A
ntig
en D
etec
tion
Test
Dev
icea
MFV
-124
R3
Mal
aria
pf (
HRP
II) /
(PAN
-LDH
) Ant
igen
Det
ectio
n Te
st D
evic
eM
FV-1
24R
Blue
Cro
ss B
io-M
edic
al (B
eijin
g) C
o., L
td.
2On
e St
ep M
alar
ia P
f Tes
t (ca
sset
te)
5223
523
One
Step
Mal
aria
P.F
Tes
t (ca
sset
te)
5223
52
CTK
Biot
ech,
Inc.
2On
site
Pf A
g Ra
pid
Test
R0
114C
3On
Site
Pf A
g Ra
pid
Test
R011
4C2
Onsi
te P
f/Pa
n Ag
Rap
id T
est
R011
3C3
OnSi
te P
f/Pa
n M
alar
ia A
g Ra
pid
Test
R011
3C2
Onsi
te P
f/Pv
Ag
Rapi
d Te
st
R011
2C3
OnSi
te M
alar
ia P
f/Pv
Ag
Rapi
d Te
stR0
112C
DiaM
ed -
A D
ivis
ion
of B
io-R
ad1
OptiM
AL-I
T 71
0024
3Op
tiMAL
-IT
7100
24
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.1
Won
dfo
One
Step
Mal
aria
Pf/
Pan
Who
le B
lood
Tes
t W
56-C
(4.0
mm
)3
One
Step
Mal
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 13
2.1. introductionTheWorldHealthOrganizationestimatesthathalftheworld’spopulationareatriskofmalaria,with225millionpeopledevelopingclinicalmalariain2009(78%inAfrica),and781,000deaths(91%inAfrica,mostbeingchildren).Malariaremainsendemicin106countries,,andwhileparasite-baseddiagnosisisincreasing,mostsuspectedcasesofmalariaarestillnotproperlyidentified,resultinginover-useofanti-malarialdrugsandpoordiseasemonitoring(1).
WHOrecommendsthatmalariacasemanagementbebasedonparasite-baseddiagnosisinallcases(2).Theuseofantigen-detectingrapiddiagnostictests(RDTs)formsavitalpartofthisstrategy,providingthepossibilityofparasite-baseddiagnosisinareaswheregoodqualitymicroscopycannotbemaintained.ThenumberofRDTsavailable,andthescaleoftheiruse,hasrapidlyincreasedoverthepastfewyears.However,limitationsofcomparativefieldtrialsandtheheterogeneousnatureofmalariatransmissionandepidemiologyhaslimitedtheavailabilityofgoodqualityperformancedatathatnationalmalariaprogrammesrequiretomakeinformeddecisionsonprocurementandimplemen-tation,andlimitstheabilitytoextrapolateresultsoffieldtrialstodifferentpopulationsandtimeperiods.Tothisendin2006,theWorldHealthOrganization(WHO),SpecialProgrammeforResearchandTraininginTropicalDiseases(TDR)andtheFoundationforInnovativeNewDiagnostics(FIND)launchedanevaluationprogrammetoassessthecomparativeperformanceofcommerciallyavailablemalariaRDTs.Thisdataisguidingprocurementdecisionsanddrivingimprovementinthequalityofmanufacturing.TheresultsofthefirstroundofProductTestingwerepublishedinApril2009,andpresentlyformthebasisofprocurementcriteriaofWHO,otherUNagenciesandnationalgovernments(3).
ThisReportprovidesdataonRound3ofProductTesting,performedattheUnitedStatesCentersforDiseaseControlandPrevention,DivisionofMalariaandParasiticDiseases(CDC) in2010-2011. Itprovidesperformancedataon50products.ThisevaluationshouldbeseenasadditivetotheRound1andRound2evaluationspublishedin2009and2010respectively(3,4).Thethreereportsshouldbeviewedtogetherasasingleevaluation,withtheexceptionthatwhereproductstestedinpreviousroundshavebeenre-submittedfortestinginRounds2or3,themostrecentresultreplacethosereportedpreviously.Theevaluationpanelswereessentiallyequivalent,andthesametestingprotocolswerefollowed.Thisreportexpandsthedatasetfrompreviousrounds,andthereforeincreasesthenumberofRDTsavailable
forprocurementthathavedetailedcomparativedataonaspectsofperformancerelevanttofielduse.
2.2. the WHo product testing programmeProductTestingispartoftheWHO-FINDMalariaRDTEvaluationProgramme.Thisprogrammedevelopsmethodsforevaluationandprovidesrelevantdataonantigen-detectingmalariarapiddiagnostictests.Theprogrammeisacollaborationofmanyinstitutionsinmalaria-endemicandnon-endemiccountries,withtheglobalspecimenbankmaintained,andthetestingperformed,atCDC(Figure2).
AllcompaniesmanufacturingunderISO13485:2003QualitySystemStandardwereinvitedtosubmituptotwotestsforevaluationundertheprogramme.The50productsfrom23manufacturers12wereevaluatedagainstpreparedbloodpanelsofculturedPlasmodium falciparumparasitesandpatient-derived,wild-typeP. falciparumandP. vivaxparasites,andaparasite-negativepanel.Thermalstabilitywasassessedaftertwomonthsofstorageatelevatedtemperatureandhumidity,andadescriptiveeaseofuseassessmentwasrecorded.Asinpreviousrounds,RDTsaregroupedintheresulttablesandfiguresintothosedetectingP. falciparum only,variouscombinationtests,andthosethathaveonlyapan-specific(orP. vivax-specific)line.Manufacturerssubmittedtwolotsofeachproductforevaluation.
Theevaluationisdesignedtoprovidecomparativedataontheperformanceofthesubmittedproductionlotsofeachproduct.Suchdatawillbeusedtoguideprocurementdeci-sionsofWHOandotherUNagenciesandnationalgovern-ments.ProducttestingispartofacontinuingprogrammeofworktoimprovethequalityofRDTsthatareused,andtosupportbroadimplementationofreliablemalariadiagnosisinareaswheremalariaisprevalent.AfourthroundofproducttestingbeganinJune2011,andresultswillbepublishedin2012.
2.3. results of the evaluation Theresults(summarizedinTables3,4,5andFiguresS1andS2)providecomparativedataontwolotsofproductsagainstapanelofparasitesamplesdilutedtoalowparasitedensity(200parasites/µl),consideredclosetothethresholdthattestsmustdetecttoreliablyidentifyclinicalmalariain
12 SincetheirapplicationforRound3,severalcompanieshavebeenacquiredbyAlere™(Table1).
2. WHo Malaria rdt prodUct testing: roUnd 3 eXecUtiVe sUMMarY
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)14
manysettings(5),andahigherparasitedensity(2000(or5000)parasites/µl).Forthepurposesofthisreport,themainmeasureofperformanceisthe‘paneldetectionscore(PDS)’;thepercentageofmalariasamplesinthepanelgivingaposi-tiveresultbytwoRDTsperlotatthelowerparasitedensity,andasingleRDTperlotatthehigherparasitedensity.Thus,itisnotameasureofRDTclinicalsensitivity,orpositivityrateagainstthepanelbutratheracombinedmeasureofpositivityrate,alongwithinter-testandinter-lotconsistency.
ConsistentwiththeperformanceofproductsincludedinpreviousroundsofProductTesting,thePDSvarieswidelybetweenproducts,withsomeproductsshowinghighperform-anceindetectingparasites,inthermalstabilityandotherperformancemeasures.Overall,thereisnoobvioustrade-offseenbetweenPDS(orpositivityrate)andfalse-positiverate,thesebeingsurrogatesforsensitivityandspecificityinthefield,respectively.Furthermore,anumberoftestsshowedgoodoutcomesonbothoftheseindicators,moresothaninpreviousrounds.Re-submittedproducts(23of50evaluated)generallymaintainedhighlevelsofperform-anceseeninearlierroundsorsubstantiallyincreasedtheirPDS.Highfalse-positiveratesareseenforseveralproductsagainstthebloodsamplescontainingspecificimmunologicalabnormalities(eg.rheumatoidfactor,anti-mouseantibodies)However,thenumberofsamplesevaluatedwassmallandtheclinicalsignificanceoftheseresultsislimited,butmaybecomeimportantincertainpopulationswithverylowparasiteprevalence.Someproductsshowavariationinperformanceindicatorsbetweenthetwolotsevaluated,underliningtheadvisabilityoflot-testingbeforefielduse.Heat(thermal)stabilityvarieswidely,withsomeproductsretaininghighpositivityratesaftertwomonthsstorageat45ºCin75%humidity.
TheclinicalsensitivityofanRDTtodetectmalariaishighlydependentonthelocalconditions,includingparasitedensityinthetargetpopulation,andsowillvarybetweenpopula-tionswithdifferinglevelsoftransmission.TheresultsinthisreportshowcomparativeperformancebetweenRDTs,andgiveanideaofwhichproductsarelikelytoprovidehighersensitivityinthefield,particularlyinpopulationswithlow-densityinfections.Ingeneral,ascountriesreducemalariaprevalenceandevenmovetowardsmalariaelimination,detectionoflowparasitedensitiesbecomesincreasinglyimportantincasemanagement.Asthepaneldetectionscoreat2000parasites/µlindicates,thesensitivityofmanyoftheseproductswillbesimilarinpopulationswithhigher
parasitedensities,althoughasubsetofanypopulationwillincludevulnerableindividualswhomaydevelopillnessatlowparasitedensities(e.g.youngchildren,pregnantwomen,thosewellprotectedbybednets)andmustalwaysbetakenintoaccountwheninterpretingRDTresults.
Inareaswheresignificantlevelsofnon-expressionofHRP2isknowntooccur,theresultsofHRP2-detectingtestsgiveninthisreportshouldnotbeconsideredpredictiveoffieldsensitivity.TeststargetingP. falciparum bydetectionofpLDHoraldolaseshouldonlybeconsidered.
Heatstability(summarizedinTable5)isvitaltomaintainingsensitivityofthetestinthefield.Asaresult,forprocurement,itisessentialthatcarefulconsiderationbegiventostabilityresultstoensurethatproductstobeusedinareaswithhightemperaturesoftransportandstoragehavedemon-stratedgreatstabilityintheproducttestingprogramme.Requirementswillvarybetweencountries:forexample,iftestsaretobedeployedinareaswheretemperaturesrarelyriseabove30°C,lessemphasisneedstobeplacedonstabilityathightemperatures.
Easeofuserequirementswillalsovary,dependingontheextentoftrainingandtheworkenvironmentoftheend-users.Particularlyinprimaryhealthcaresettings,thesimplerthetests,theeasieritwillbetoavoiderrorsinpreparationandinterpretation.
2.4. Use of these resultsTheresultsincludedinthisreportshouldbeconsideredtogetherwiththoseofRound1(2008)andRound2(2009),withtheresultsofre-submittedproductsreplacingthosereportedinearlierrounds(3,4).Ultimately,itisimperativethatprocurementdecisionsbasedontheseresultstakeintoconsiderationlocalconditionsofmalariatransmissionandillnesswherethetestswillbeused(e.g.Plasmodiumspecies,targetantigenvariation,parasitedensities,climate).ProcurementofRDTsmustnotoccurwithoutprogrammaticandinfrastructurepreparationforproperuse,includingsupplychainmanagement,trainingontestusageanddisposal,andtrainingonpatientmanagementinresponsetoresults.Thisreportprovidesanalgorithmtoassistinthisdecision-makingprocess(Annex5a).Furthermore,comprehensiveguidanceonseveralaspectsofprocurementcanbefoundin‘GoodPracticesforselectingandprocuringrapiddiagnostictestsformalaria’(6).
eXec
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 15
3. backgroUnd
In2010,WHOestimatedthat3.3billionpersonswereatriskofacquiringmalaria.Ofthese,225millionpeoplewereinfectedin2009(78%inAfrica),and781,000died(91%inAfrica,mostbeingchildren).Malariaremainsendemicin106countries(1).
Inthepastdecade,majornewopportunitiesforthecontrolofmalariahaveemerged, includingimplementationoflong-lastinginsecticidalnets,indoorresidualsprayingofinsecticidesandartemisinin-basedcombinationtherapy(ACT).Thesetools,incombinationwithincreasedcoverageofmalariacontrolprograms,arelikelytoreducetheburdenofmalariainfectionincountrieswheretheyareadequatelyimplemented.Inturn,theproportionoffebrileepisodesattributabletomalariaislikelytodecreasesubstantially.
DespiteWHOrecommendationsforlaboratory-confirmeddiagnosisofmalariainfectionspriortotreatmentinallcases(2),diagnosisisoftenmadeonclinicalgrounds(5).However,inmostendemicareasmalariamakesupaminorityof‘malaria-like’febrileillness.Microscopyhasbeenthecornerstoneofdiagnosisandisrecommendedformalariadiagnosiswhereitsqualitycanbemaintained,buttheneedfortrainedpersonnel,adequatereagentsandequipment,limititsavailabilityandaccessibilitytomanypeopleinmalaria-endemicareas.Rapid,accurateandaccessiblediagnostictoolsarebecomingincreasinglyimportant,asprogrammesexpandparasite-baseddiagnosisandtheprevalenceofmalariadecreases.Inrecentyears,rapiddiagnostictests(RDTs),whichdetectPlasmodium-specificantigens(proteins)inwholebloodofinfectedpeople,haveemergedasanattractive
alternativetomicroscopy.CurrentlyavailableRDTscomeinvariousformats(dipstick,cassetteorcard)andcontainboundantibodiestospecificantigenssuchashistidine-richprotein-2(HRP2)(specifictoP. falciparum),pan-specificorspecies-specificplasmodiumlactatedehydrogenase(pLDH)oraldolase(specifictoallthemajorPlasmodiumspecies:P. falciparum,P. vivax,P. malariae,P. ovale(Figure1).
Tobewidelyuseful,aRDTmusthavehighsensitivitytoensureallclinically-significantmalariainfectionsaredetected;highspecificitytoenablemonitoringoflowmalariaprevalenceandappropriatemanagementofnon-malarialfever;andhighstabilitytoallowtransportandstorageinambientconditionsinmalaria-endemicareas.PublishedfieldtrialsofRDTsshowhighvariabilityinperformance,likelyduetoinadequatequalityofmanufacture,incorrectstorageandhandling,poorpreparationandinterpretation,andsometimespoorstudymethods,analysisandreporting(7-13).Ingeneral,diagnostictesting(bymicroscopyorRDT)toalevelof200parasites/µlwillreliablydetectnearlyallclinicallyrelevantinfectionsinmalaria-endemicareas(5).
ThenumberofRDTsavailableonthemarkethasgrownrapidlysincetheirintroductioninthelate1990s.Itisestimatedthatthereare60brandsandover200testscommerciallyavailabletoday,withanestimated100milliontestsormorefinancedin201113However,regulatoryoversightofdiagnosticsisoftenweak,andprocurementagencieshavefacedconsiderableproblemsinselectingappropriateRDTsandensuringquality.Inviewoftheinconsistencyinfieldstudyresultsandtheinherentdifficultiesinassessinglargenumbersofproductsinastandardizedwaythroughfieldtrials,WHOandvariouspartnersembarkedonaMalariaRapidDiagnosticTestProductEvaluationProgrammein2002todevelopandemploystandardizedassessmentofmalaria
13 Tracking Progress in Scaling-Up Diagnosis and Treatment for Malaria.Geneva.2009.RollBackMalariaPartnership.
Figure 1: Mode of action of antigen-detecting malaria RDTs
a
b
c
Bound Ab
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Captured Ag–labelledAb complex
Capturedlabelled Ab
Parasite Agcaptured bylabelled Ab
Labelled Ab–Agcomplex capturedby bound Ab oftest band
Lysing agentand labelled Ab
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Labelled Abcaptured by bound Ab ofcontrol band
ModeofactionofcommonmalariaRDTformat:
(a)Dye-labeledantibody(Ab),specificfortargetantigen, is present on the lower end of thenitrocellulosestriporinawellprovidedwiththestrip.Antibody,alsospecificforthetargetantigen,isboundtothestripinathin(test)line,andeitherantibodyspecificforthelabeledantibody,orantigen,isboundatthecontrolline.
(b)Bloodandbuffer,whichhavebeenplacedonthestriporinthewell,aremixedwiththelabeledantibodyandaredrawnupthestripacrossthelinesofboundantibody.
(c)Ifantigenispresent,somelabeledantibodywillbetrappedonthetestline.Otherlabeledantibodyistrappedonthecontrolline.
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)16
RDTperformance,andtoguideprocurementdecisionsandregulatorymechanisms.TheProgrammehasbeenoverseenbyWHOandTDRinpartnershipwithFIND,andhasbeenguidedbyaSteeringCommitteeandtechnicalconsultationsfrom2003to2011overseeingthedevelopmentofstandardoperatingprocedures(SOPs)fortheprogramme(16 ).AnetworkofspecimencollectionsiteswasestablishedtocontributespecimenstoaglobalbankattheCDCandtofacilitatelocalqualitycontrolactivities(Figure2).
ThereportofthefirstandsecondroundsofProductTestingwasreleasedin2009and2010,respectively(3).Thisthirdreportaddsperformancedataon27newproductsand23re-submittedRDTs.TestingforRound3wasconductedagainstanevaluationpanelwithsimilarcharacteristicsintermsofoverallantigenconcentration,parasiteorigin,andparasite-negativebloodsamples,topreviouspanels.Themajorityofpanelsampleswereretainedfrompreviousrounds.TheresultsshouldbeconsideredtogetherwiththosefromRound1andRound2(3, 4).
4. objectiVe
EvaluatemalariaRDTstoproduceperformancedatatoguideprocurementofRDTsforuseinthefieldinmalaria-endemiccountries.
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
Abbreviations:CDCCentersforDiseaseControlandPrevention(Atlanta,UnitedStatesofAmerica);CIDEIMCentroInternacionaldeEntrenamientoyInvestigacionesMédicas(Cali,Colombia);DMRExperimentalMedicineResearchDivision(DepartmentofMedicalResearch,Yangon,Myanmar);EHNRIEthiopianHealthandNutritionResearchInstitute(AddisAbaba,Ethiopia);HTDHospitalforTropicalDiseases(London,UnitedKingdomofGreatBritainandIreland);IHRDCIfakaraHealthResearchandDevelopmentCenter(Bagamoyo,TheUnitedRepublicofTanzania);IMTInstitutodeMedicinaTropical(UniversidadPeruanaCayetanoHeredia,Lima,Peru);IPBInstitutPasteurdeBangui(Bangui,CentralAfricanRepublic);IPCInstitutPasteurduCambodge(PhnomPenh,Cambodia);IPMInstitutPasteurdeMadagascar(Antananarivo,Madagascar);KEMRI:KenyaMedicalResearchInstitute(Kisumu,Kenya);QIMRQueenslandInstituteofMedicalResearch(Brisbane,Australia);RITMResearchInstituteofTropicalMedicine(Manila,ThePhilippines);UCAD:UniversitéCheikhAntaDIOP(Dakar,Senegal);ULUniversityofLagos(Lagos,Nigeria).
Me
tHo
ds
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 17
5. Materials and MetHods
5.1. test selection InOctober2009,theWHO-FINDMalariaRDTEvaluationProgrammeissuedacallforexpressionofinteresttomanu-facturersofmalariaRDTsalongwithinformationregardingtherequirementsforsubmissionofaproducttoRound3oftheProductTestingProgrammeandtheconditionsforparticipationintheEvaluationProgramme.14Requirementsincluded:ISO13485:2003certification,supplyofsufficientquantitiesofproducts(1100testsfromeachof2lots),compliancewiththeproductdefinition15anddeadlinesfordocumentsubmission.
Twenty three manufacturers, including 62 products,respondedtothecall.Inordertokeeptoscheduleandbudget,manufacturerswereaskedtolimittheirproductsubmissionstotwo.ThefinalnumberofproductsincludedinRound3was50.Basedoncataloguenumbersandverificationwithmanufacturers,23ofthe50products(46%)werepreviouslysubmittedtoeitherRound1orRound2(TableS3).After
14 http://www.wpro.who.int/sites/rdt/who_rdt_evaluation/call_for_testing_round3.htm
15 Workingdefinitionofaproductcanbefoundhereonpage13:http://www.wpro.who.int/internet/resources.ashx/RDT/docs/pdf_version/web3_QARDTreport.pdf(accessed8September2011)
initialevaluationagainsttheP. falciparumculture-derivedpanel(Phase1),allproductsmetminimumperformancerequirements16andproceededtothefullevaluation.
Insummary,ofthe50productsfullyevaluated:15aredesignedtodetectP. falciparumalone,32todetectanddifferentiateP. falciparumfromnon-P. falciparummalaria,and3todetectP. falciparumandnon-P. falciparummalariawithoutdistinguishingbetweenthem.Annexes1and2provideacomprehensiveoverviewofproductcharacteristics.
5.2. outline of the product testing protocol ThetestingprocessisoutlinedinFigure3andintheMethodsManualforProductTestingofMalariaRapidDiagnosticTests-Version3(16).Inbrief,RDTsfromeachoftwolotsofeachproductwereevaluatedagainstapanelofparasite-positiveandparasite-negativecryo-preservedbloodsamples,andapanelofparasite-negativesamples.Bothlotswerealsotestedforheat(thermal)stability,evaluatedbeforeandaftertwomonths’storageat4°C,35°Cand45°C.Finally,anease-of-usedescriptionwasdevelopedusingastandardassessmentformat.
ThetestingprocessandallresultswereoverseenbytheWHO-FINDMalariaRDTEvaluationProgrammeCommittee,andmanufacturersweregiven60daystocommentonindividualproductresultspriortopublication.
16 PDS>80%againsthighdensity(2000p/µl)P. falciparumculturesamples
Figure 3: Malaria RDT Product Testing Overview
PANEL DETECTION SCOREAND FALSE POSITIVE RATE
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)18
Table 1: Manufacturers and products accepted into Round 3 of WHO Malaria RDT Product Testing Programme
Manufacturer Product Name Catalogue Numbera Target antigen(s)
ABON Biopharm (Hangzhou) Co. Ltdb
ABON Malaria Pan/P.f. Rapid Test Device (Whole Blood) IMA-B402 HRP2 aldolase
Access Bio, Inc.
CareStart ™Malaria pLDH 3 Line Test G0121 pan pLDH pf pLDHCareStart™ Malaria/Pregnancy Combo (pLDH/HRP2/HCG) G0221 HRP2 pan pLDH HCG
CareStart™ Malaria Screen G0231 Pf HRP2/Pf pLDH pan pLDH
ACON Biotech (Hangzhou) Co. Ltdb
Surestep™ Malaria Pf/Pan Rapid Test Device (Whole Blood) IMA-T402 HRP2 aldolase
AZOG,Inc
Malaria pf (pLDH) / PAN-pLDH Test Device MFV-124 pan pLDH pf pLDHMalaria pf (HRP II) / pv (pLDH) Antigen Detection Test Device MFV-124V pv pLDH HRP2
Malaria pf (HRP II) / (PAN-LDH) Antigen Detection Test Device MFV-124Rc pan pLDH HRP2
Bioland, LtdNano Sign Malaria Pf Ag RMAF10 HRP2NanoSign Malaria Pf/Pan Ag RMAP10 HRP2 pan pLDHNanoSign Malaria Pf/Pv Ag RMAD10 pan pLDH pf pLDH
BioNote,Inc.BIONOTE MALARIA P.f&P.v Ag Rapid Test Kit RG19-12 HRP2 pv pLDHBIONOTE MALARIA P.f&Pan Ag Rapid Test Kit RG19-08 HRP2 pan pLDHBIONOTE MALARIA P.f Ag Rapid Test Kit RG19-11 HRP2
BiosynexIMMUNOQUICK CONTACT falciparum 0519K25 HRP2IMMUNOQUICK CONTACT MALARIA +4 0525K25 HRP2 pan pLDH
Blue Cross Bio-Medical (Beijing) Co., Ltd. One Step Malaria P.F Test (cassette) 522352c HRP2
Core DiagnosticsCore™ Malaria Pf MAL-190020 HRP2Core™ Malaria Pv/Pf Mal-190022 HRP2 pv pLDHCore™ Malaria Pan/Pv/Pf Mal-190026 HRP2 pan pLDH Pv pLDH
CTK Biotech, Inc.OnSite Pf Ag Rapid Test R0114Cc HRP2OnSite Pf/Pan Malaria Ag Rapid Test R0113Cc HRP2 pan pLDHOnSite Malaria Pf/Pv Ag Rapid Test R0112Cc HRP2 Pv pLDH
DiaMed - A Division of Bio-Rad OptiMAL-IT 710024c Pan pLDH Pf pLDHDima • Gesellschaft für Diagnostika mbH Malaria Pan test MAL-W23N-001 HRP2 aldolase
ICT DiagnosticsICT Diagnostics Malaria Combo ML02c HRP2 aldolase ICT Diagnostics Malaria Dual ML03 HRP2 pan pLDHICT Diagnostics Malaria P.f ML01c HRP2
InTec Products, Inc.Advanced Quality™ One Step Malaria P.f/P.v Tri-line Test ITP11003 TC40 HRP2 pv pLDH
Advanced Quality™ One Step Malaria P.f Test ITP11002 TC40c HRP2J. Mitra & Co. Pvt. Ltd. Advantage Malaria Card IR211025 HRP2 Pv pLDH
Orchid Biomedical Systems
Paracheck® Pf Device - Rapid test for P. falciparum Malaria (Ver. 3) 30301025c HRP2
Paracheck® Pf Dipstick - Rapid test for P. falciparum Malaria (Ver. 3) 30302025c HRP2
Orgenics Ltd.b Clearview® Malaria pLDH 70884025 pan pLDH
Standard Diagnostics Inc.b SD BIOLINE Malaria Ag 05FK40c pan pLDH pf pLDHSD BIOLINE Malaria Ag P.f/Pan 05FK60c HRP2 pan pLDHSD BIOLINE Malaria Ag P.f (HRP2/pLDH) 05FK90 HRP2 Pf pLDH
Span Diagnotics Ltd.ParaHIT® - f (Device) 55IC102-10c HRP2ParaHIT® - f (Dipstick) 55IC101-10c HRP2
SSA Diagnostics & Biotech Systems
diagnosticks MALARIA (Pan) Cassette MPNWBC1007.3 pan pLDHdiagnosticks MALARIA (Pan/Pf) Cassette MPNFWBC1007.4 HRP2 pan pLDHdiagnosticks MALARIA (Pan/Pv/Pf) Cassette MPNVFC1007.5 HRP2 pan pLDH Pv pLDH
Vision Biotech (Pty) Ltd.bClearview® Malaria Combo VB11c HRP2 aldolase Clearview® Malaria Pf VB01c HRP2Clearview® Malaria Dual Test Device VB20c HRP2 pan pLDH
Guangzhou Wondfo Biotech Co. Ltd.
One Step Malaria P.f./Pan Whole Blood Test W56-Cc HRP2 pan pLDHOne Step Malaria P.f Test W37-Cc HRP2
Zephyr Biomedical SystemsMalascan™ Device - Rapid test for Malaria Pf/Pan 50402025c HRP2 aldolaseParabank™ Device - Rapid test for Malaria Pan 50301025c pan pLDHParascreen™ Device -Rapid test for Malaria Pan/Pf 50310025c HRP2 pan pLDH
a Some products may include different catalogue numbers for different box sizes, contact manufacturers for details.b Since enrolment in WHO Malaria Product Testing Round 3, these have become Alere ™ companies.c These products have also been submitted to previous rounds of WHO Malaria RDT Product Testing (Round 1 or 2). For details on all product resubmissions see Table S3.
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 19
5.3. evaluation panelsRDTswereevaluatedagainstthreepanels,specifically:i) P. falciparumculturelines(includesasubset,‘manufac-
turer’spanel’)atlow(200parasites/µl)andhighparasitedensities(2000parasites/µl).
ii) Wild-typePlasmodiumspecies(P. falciparum,P. vivax)fromnaturallyinfectedhumansandparasite-negativesamplesatlow(200parasites/µl)andhighparasitedensities(2000(or500017)parasites/µl).AllsamplesarepreparedfromisolatesthatexpressHRP2.
iii) Parasite-negativepanel(‘clean’samplesanddisease-specificorbloodfactor-specificsamples).
Anoverviewofthesamplecollectionandcharacterizationprocesscanbefoundinthemethodsmanualsdevelopedforthispurpose(16-17).CharacterizationresultscanbefoundontheWHO/WPRORDTandFINDwebsites18
Insummary,eachpanelspecimenwascharacterizedfor:i) Speciesbyduplicatemicroscopy(twomicroscopists)and
confirmationbynestedPCRofmono-speciesinfection
ii) Antigenconcentration,determinedbyquantitativeELISAforHRP2,pLDH,aldolase
iii) PCRformalariaandconfirmatorytestingforotherpathologyinthecaseofparasite-negativesamples
Mostsamplesintheglobalspecimenbankarealsocharacter-izedaccordingtoHRP2sequencebyPCRamplification.Thisisnolongerperformedonsamplescollectedafter2009,as
17 8(8%)ofthe99P. falciparumdilutionsamplessetswere200and5000parasites/µland2(6%)ofthe35P. vivaxdilutionsamplesetswere200and5000parasites/µl
18 http://www.wpro.who.int/sites/rdt/who_rdt_evaluation/call_for_testing_round3.htm-http://www.finddiagnostics.org/
accumulatedevidenceindicatesnosignificanteffectonRDTsensitivity(18).Allsampleshavetheirgeographicaloriginrecorded.
panel compositionP. falciparum-cultured parasites panel
Twentyculture-adaptedstrainsofP. falciparumofvariedgeographicaloriginwereselected,including15strainswithtypeBHRP2sequence,3withTypeA,and2withTypeCHRP2sequence.AllspecimenswerederivedfromtheculturebankofCDC,anddilutedinO+USAdonorblood(16).
Wild-type parasite panel
Theparasite-positivewild-type(clinical)panelconsistedofsamplesfrom99casesofP. falciparumand35casesofP. vivax,derivedfrom11collectionsitesinAsia,AfricaandSouthAmerica(Figures2,4aand4b).
Sampleswerecollectedfromfebrilepatientsandprocessedaccordingtostandardizedmethodsdesignedtopreservetargetantigenconcentration (17).Afterdilutionsandcryo-preservation,samplesweretransferredtotheglobalbankatCDCforfurthercharacterization.ThedistributionofconcentrationofHRP2,aldolaseandpLDHweredeterminedonalargersampleduringthefirstroundofproducttestingin2008,andatestpaneldevelopedforthatroundthatexcludedsampleswithextremesofhighorlowantigenconcentration.Panelsforsubsequentrounds,includingRound3,havebeenmaintainedwithintheseparameters.
Negative blood samples
Thenegativepanelconsistedof‘clean’parasite-negativesamplesfromdonor-derivedbloodobtainedinbanksorfromvolunteersinnon-endemic(USA)andendemicareas(Philippines,Madagascar,Senegal,NigeriaandKenya),having
Figure 4a: Origin of Phase 2 P. falciparum wild type (clinical) samples (n=99)
Figure 4b: Origin of Phase 2 P. vivax wild type (clinical) samples (n=35)
Nige
riaCe
ntra
l
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ited
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)20
beenmalaria-negativebymicroscopy.Thepanelfurthercontainsparasite-negativesamplesfromdonorswithdiseasesthatmaypotentiallybeinthedifferentialdiagnosesofmalaria,orcontainspecificbloodfactorsknowntobecommoninthecommunityorknowntohavethepotentialtocausefalse-positivereactionsonimmunochromatographictests(Table2).AllnegativecontrolsampleswereconfirmedtobefreeofPlasmodiumparasitesbyPCRamplification.
Furtherdetailsoftheculture,wild-typeandparasite-negativepanelscanbefoundat http://www.wpro.who.int/NR/rdonlyres/62AA6F12-638E-4C1E-B7CC-10014B2273CA/0/RndThreeProdTestEvalPanel_Pub.pdf(accessed13September,2011).
5.4. rdt registrationThereceiptofeachshipmentofRDTsattheevaluationcentrewasrecordedinadedicatedRDTregister.Temperaturemonitoringdeviceswereofferedtomanufacturersfreeofcharge,toaccompanyRDTsshipmentstoCDC.AllRDTswerestoredat≤25°Cimmediatelyandtemperaturemonitorswerelabelledwithreceiptdateandforwardedfordownloading,whenapplicable.
5.5. specimen panel registrationAllpanelspecimenswereassigneduniqueidentificationnumbersatthecollectionsitesandstoredinaliquotsof50µLat-70°Cuntilthetimeoftesting.Alldatapertainingtospecimenidentification,storagelocationandcharacterizationresultsarestoredinasecure,dedicateddatabase.
5.6. test phasesTheevaluationwasdividedintotwotestingphases:Phase 1 -AscreeningsteptoallowtheselectionofRDTsmeetingminimalqualityrequirements.Productsfromtwolotswereevaluatedagainstapanelof20culture-derivedP. falciparumsamplesathigh(2000parasites/µl)andlow(200parasites/µl)parasitedensities.ProductsnotdesignedtodetectP. falciparumwereexcludedfromPhase1.Tomovetothefullevaluation(Phase2),aproductevaluatedinPhase1musthaveachievedan80%paneldetectionscore(PDS)againstthe2000parasites/µlsamples(Figure6)
Phase 2 -Productsfromtwolotswereevaluatedagainstapanelofdilutedclinicalbloodsamplescontainingwild-typeparasitesandaparasite-negativepanel,evaluatedforheat(thermal)stability,andassessedforease-of-use.
a. Theparasite-positiveandparasite-negativepanelwascomprisedof99P. falciparum,35P. vivaxattwoparasitedensities(200parasites/µland2000(or5000)19parasites/µl),and100parasite-negativecontrols.
b. Heatstabilityevaluation:Baselinetestingof15RDTsfromeachoftwolotsagainstasingleculture-derivedP. falciparumisolate(NigeriaXIIstrain,PfHRP2sequencetypeBwith
19 Eight(8%)ofthe99P. falciparumdilutionsamplessetswere200and5000parasites/µland2(6%)ofthe35P. vivaxdilutionsamplesetswere200and5000parasites/µl
atypicalantigenconcentration)at200parasites/µland5RDTsfromeachlotat2000parasites/µl,and4RDTsfromeachlotagainstanegativesample.ThisprocedurewasrepeatedafterRDTsweremaintainedfor60daysat4°C,35°Cand45°Cat75%humidity.
c. Ease-of-useassessment:Afterbecomingfamiliarwiththetestdevice,techniciansjointlydescribedthetestforbloodsafetycharacteristics,qualityofinstructions,numberoftimedstepsandtotaltimetoresult,usingastandardreferenceguide (16).
5.7. performing rapid testsAllRDTswerebroughttoroomtemperaturepriortofirstuse.Desiccantwasinspectedforcolourchangesandproductswerediscardedifpresent.RDTswerelabelledwithsampleidentificationnumber,dilution,andthedatewhentestwasperformed.Performanceofrapidtestswasinaccordancewithmanufacturer’sinstructions,withtheexceptionthatbloodtransferwascarriedoutbymicro-pipettefromthesampletube.Theresultwasrecordedbyatechnicianattheminimumspecifiedreadingtime.Asecondtechnicianre-readtheresultwithin1hourforinternalmonitoringpurposesandforinformationformanufacturers.Technicianswererotated,andblindedtosampletypeandtoeachother’sresultsduringPhase2.Annexes1and2containadescriptiveandillustratedsummaryofthetestcharacteristics,stepsandguidetointerpretationofresults.
5.8. interpretation of resultsResultsofcontrolandtestlineswererecordedasnegativeorpositivebyeachtechnician.Eachtestwasreadagainstastandardcolourchartandthebandintensitygradedas0(novisibleband),1,2,3or4.Ifthecontrollineisrecordedasabsentbyeithertechnician,thetestisrecordedasinvalid.
Figures5and6illustratethetestingsequenceatlowandhighparasitedensities.
Table 2: Characteristics of Plasmodium spp. negative samples
Nature of negative samplea No.
Clean-negativeb 50
Anti-nuclear antibody positive (sera) 13
Anti-mouse antibody positive (plasma) 3
Rheumatoid factor positive (whole blood and sera) 4
Rapid plasma reagin positive (sera) 9
Chagas' disease antibody positive (plasma) 2
Dengue antibody positive (whole blood sera) 4
Leishmaniasis antibody positive (sera) 5
Schistosomiasis antibody positive (whole blood and sera) 10
a Whole blood, unless otherwise indicated. Sera and plasma samples were reconstituted packed cells
b Healthy volunteers with no known current illness or blood abnormality
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 21
6. data ManageMent
ThereceiptofproductswashandrecordedinanRDTregisterattheCDCasperStandardOperatingProcedures(SOPs).DataassociatedwithspecimencollectionandcharacterizationwasrecordedfirstonhardcopyreportformsaspertheSOPsatthecollectionsites(Figure2),HTD(ELISAreporting)and
CDC(PCR)andthenentereddirectlyintoExcelfollowedbyimportationintoaspeciallydevelopeddatabase.
TheresultsoftheproductpaneltestingandheatstabilitytestingconductedattheCDCwererecordedonreportformsbyeachtechnicianindividually,aspertheSOP.Theseresultsweredouble-dataentered,andanalysedfordiscrepancies.
Allsourcedocumentsandelectronicrecordsofstudydataaremaintainedinsecurestorageuntiltheconclusionoftheevaluation,dataanalysisandreportpublication.
Individualproducttestingreportsandaccompanyingrawdataweredistributedtomanufacturers’inJuly2011,fora60daysreviewperiodpriortopublicationofthefinalreport.
Figure 5: Testing procedure and calculation of ‘panel detection score’ and band intensity for Product A against a sample density of 200 parasites/µlThefirstreadingwasattheminimumtimespecifiedbythemanufacturer;thesecondreadingwasuptoonehourlatera.Asampleisconsidereddetectedonlyifallfirsttestreadings,frombothlots,arepositiveie.Readingsa,b,canddmustbepositive.
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
Detected if 4 positive
first-readings
Basedonthepositiveresultsoffirsttestreading(2testsperlot),themeanbandintensityscore=a+b+c+d/4(excludingnegativeresults).
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 Thefirstreadingwasattheminimumtimespecifiedbythemanufacturer;thesecondreadingwasuptoonehourlatera.Asampleisconsidereddetectedonlyifallfirsttestreadings,frombothlots,arepositiveie.Readingsaandbmustbepositive.
Product A
aReading
1Reading
2
Test 1
Lot 1
bReading
1Reading
2
Test 2
Lot 2
Detected if 2 positive
first-readings
Basedonpositiveresultsoffirsttestreading(2testsperlot),ineachlot,themeanbandintensityscore=a+b/2
a second reading results are for internal use only
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)22
7. QUalitY assUrance
ProducttestingfollowsSOPsdevelopedthroughpriortestingexperienceandarebasedonrecommendationsofexpertconsultations,withminormodificationsmadeonsuggestionbytheSteeringCommitteepriortoRound2 (16).Thequalityofcriticalstepswascontrolled,asfollows:
i) Quality of the malaria RDTs and their use:
AllRDTswerestoredinacontrolledenvironmentat≤25°C;thepouchwasopenedanddesiccantcheckedimmediatelybeforeuse;manufacturerinstructionswerefollowedwiththeexceptionofuseofthebloodtransferdeviceprovidedbythemanufacturer(amicropipettewasusedtoensurecorrectbloodvolume).
Atemperature-monitoringdevicewasofferedtobeincludedwiththeRDTsforshipmenttothetestingsite.Logswereanalysedforanytemperaturesbeloworabovemanufacturersrecommendedstorageconditions.
ii) Quality and objectivity of the RDT reading results:
Resultswerereadingoodlightingbytrainedtechnicianstestedforvisualacuity,anddoublyenteredintothedatabase.Technicianswererotated.Readingsofasecondtechnicianwereusedforinternalmonitoringpurposes,andsummarizedresultsreviewedindetailandpotentialdiscrepanciesidenti-fiedandcross-checkedagainstsourcelaboratoryreportforms.
Allwild-typeparasitesampleswererandomizedwithpara-site-negativesamplesandre-labelledforblindedreadingoftheRDTresults.
iii) Quality of the specimen bank samples:
SOPswereestablishedforthepreparationofallspecimenbanksamples (17).Culturelinesofparasitesandwild-typesampleswereselectedtakingintoaccountpreviousevidenceanddatafromspecificallyconductedstudies.Alldilutedparasitesampleswerestoredandtransportedat-70°C,andwereusedonlyoncewithin8hoursofthawing.
iv) Quality of the product testing site:
TheDivisionofMalariaandParasiticDiseases,CDC,isoneofthemajoroperatingcomponentsoftheDepartmentofHealthandHumanServices(HHS)oftheUSA.ThelaboratoryholdsClinicalLaboratoryImprovementAmendments(CLIA)accreditationandismonitoredbyinternalqualitymanage-mentsystems(QMS)programmes.
8. etHical considerations
EachspecimencollectionsiteobtainedapprovalfromaWHOResearchEthicsReviewCommitteeand/orlocalinstitutionalreviewboardforspecimencollection,transportandarchivingofbloodsamplesforthepurposeofproducttesting,lottestingandqualityassuranceprocedures.
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 23
9. data analYsis
9.1. Measures of parasite detection: panel detection score and positivity ratesMalariaRDTsdetectparasite-derivedantigen.Therelationshipoftheconcentrationofantigenavailablefromthebloodsample(afterlysisofredcellsandparasites)totheperipheralparasitedensityvarieshighlyduetoaseriesofhostandparasitefactors.Inaddition,thepopulationfrequencyofspecificfactorsthatcanresultinfalse-positiveresultsmayvary.Therefore,fieldsensitivityandspecificityofanRDTmaychangeindifferentepidemiologicalsituations.Theevaluationreportedheredoesnotpredictsensitivityorspecificityinagivenfieldsituation.Itreportscomparativedetectionoftargetantigensandfalse-positiveratesofRDTsagainstastandardizedpanel,inacontrolled,repeatablemanner.Asthepanelisdevelopedtobeacloseapproximationoffieldsamples,thecomparativedetectionratesbetweenproductsareexpectedtobereflectedbysimilarcomparativedetectionratesinthefield.AsthepanelisdesignedtoincludealargenumberofsamplesclosetothelimitsofdetectionofRDTs(200parasites/µl),thepanelislikelytodiscriminatemoreclearlythanafieldtrial.Itfollowsthatinsomesettings,suchaswhereparasitedensityisveryhigh,differencesinthepaneldetectionscore(PDS)andpositivityratesbetweentestsobservedagainsttheWHOevaluationpanelmaynotbeobservedinpatientpopulations,ormaybemuchsmaller.Furthermore,whereparasitedensitiesareverylow,detectionratesmaybelowerthanthosereportedhere.
ReferringtoFigure5,aproductmustreturnfourpositivetestresultsatthemanufacturers’recommendedminimumreadingtime(twofromLotOne,twofromLotTwoattheinitialreadingtime)whentestedagainstaparasitedensityof200parasites/µl,tocontributetoitsPDS.Whentestedagainst2000or5000parasites/µl(Figure6)theproductmustreturntwopositivetestsatthemanufacturers’recommendedminimumreadingtime(onefromeachlot).Thus,thePDSisameasureofinter-testandinter-lotconsistency,aswellastheabilitytodetectantigen.ThePDSforP. falciparumindicatesanRDTresultconfirmingthepresenceofP. falciparum, whentestedagainstculturedandwild-typeP. falciparumsamples,whilethenon-P. falciparum PDS(P. vivax detectioninthisReport)indicatesPlasmodium-positive/P. falciparum-negativeresultswhentestedonwild-typeP. vivaxsamples.
Thepositivityrateisthepercentageofalltestsofaparticularproductthatreturnedapositivetestresult,atthemanufac-turers’recommendedminimumreadingtime,whentestedagainstaP. falciparum or P. vivax sample.
9.2. false-positive resultsFalse-positiveresultsareanalysedandreportedastwoseparategroups;thosethathadincorrectspeciesidentifica-tion,andthosethatreturnedapositiveresultforsamplesnotcontainingPlasmodiumspp.parasites.Specifically,thefalse-positiverateisthepercentageofalltestsofaparticularproductthatreturnedapositivetestresultwhenitshouldn’thave,basedonresultsatthemanufacturersrecommendedminimumreadingtime.
9.2.1. incorrect species identificationAtestisconsideredasreturninganincorrectspeciesresultifapositiveP. falciparumtestlineappearsupontestingagainstasamplecontainingnon-P. falciparum (P. vivax)parasites.P. falciparumsamplesresultinginonlyavisiblepan-specific(ornon-P. falciparum-specific)testlineoncombinationtestsarealsoconsideredtobefalse-positives.
9.2.2. false-positives from plasmodium-negative samplesAnytestthatproducesapositivereadingtosampleswithnoPlasmodiumparasitesisconsideredafalse-positive.InPhase2,parasite-negativesamplesconsistofclean-negativesamplesandalsosamplescontainingotherinfectiousagents(e.g.Dengue,Leishmania,Chagas)andimmunologicalfactors(eg.rheumatoidfactor,anti-nuclearantibodies,anti-mouseantibodies)(Table2).
9.3. band intensityAllpositivetestsresultswererecordedaccordingtothebandintensityagainstastandardreferencechart,matchedcloselytolinecolour.Basedonthefirstreaderresults,thedistributionofbandintensityresultsispresentedasthemeanbandintensityofpositiveresults.Inaddition,theintensitywasexpressedforeachpossibleresult(0,1,2,3or4)20asthepercentagerecordedatthatlevel.
9.4. lot agreement Disagreementbetweentestlotsiscalculatedfromthenumberofsamplesthatreturnedapositiveresulton both RDTstestedinthatlotagainstparasite-positivesamplesat200parasites/µl,andonthesingleRDTfromeachlottestedagainstsamplesat2000(or5000)parasites/µl.Thus,highinter-lotagreementindicatesconsistencyindetectingmalariaparasites.Whereonetestwasinvalidandtheotherpositive,positiveagreementwasrecorded.
9.5. invalid testsThetotalnumberofteststhatweredeemedinvalidduringtestingofbothlots,usingsamplesat200parasites/µland2000(or5000)parasites/µl.
20AstandardintensitycomparisonchartisusedwhichallowsmatchingtotheclosestoffourcommoncolourvariantsoflabelledantibodiesusedonRDTs,eachatfourlevelsofintensity.
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)24
9.6. Heat (thermal) stability Theresultsofheatstabilitytestingarereportedasthenumberofpositivetestsfromtwolotsreturnedateachparasitedensity(maximumscore30against200parasites/µlsamples;10against2000parasites/µlsamples)21andmeanbandintensity(forpositivetestsonly)atbaselineandafterlotswerestoredat4°C,35°Cand45°CfortwomonthsagainstoneculturedP. falciparumparasitesampleat200and2000parasites/µl.
21 Fifteentestsperlotagainst200parasites/µlsamplesand5testsperlotagainst2000parasites/µlsamples.Invalidresultswereexcludedfromanalysis.
10. laboratorY VersUs field-based Malaria rdt eValUations
Despitethestrengthsoftheproducttestingprogramme,theevaluationisnotcompletelyanalogoustofieldtestingofmalariaRDTs.InordertocomposeapanelthatcouldbereproduciblyusedtoevaluateRDTs,bloodsampleswerediluted,frozenandstoredbelow−70°C.Bloodthathasundergoneafreezethawprocessandisthereforelysedmaynothaveexactlythesamecharacteristicsasfreshblood.Afurthervariationfromfieldequivalenceistheuseofamicro-pipettetosupplybloodtotheRDTdeviceratherthanthebloodtransferdeviceprovidedbythemanufacturer.Thiswasnecessarybecausebloodiscollectedfromacryo-tuberatherthanafinger-prick,andthebloodtransferdevicesprovidedwithaparticularproductcanvary.Thistechniquealsoensuredconsistencyoftestingbyreducingthelikeli-hoodofoperatorerror.AllsamplesinthepanelusedfortheevaluationarepreparedfromparasitesthatexpressHRP2.TheresultswillthereforenotbepredictiveoffieldtrialresultsinvolvingparasitepopulationswithsignificantlevelsofHRP2deletion(20).
Fieldtrialshaveaplaceinproductselection,particularlyindeterminingwhichofashort-listofproductsismostappropriateforthetechniciansandsituationofitsintendedusebyaprogramme(e.g.ease-of-usecharacteristics).Suchtrialsshouldhavecarefullydefinedobjectivesandproceduresdesignedtoachievethese.Trialstodeterminethelikelyfieldsensitivityandspecificityofaproductalsohaveaplace,butrequirelargesamplesizesandpopulationswithlowparasitedensitiestodeterminesignificantdifferencesbetweenwell-performingproducts,theyneedtobetightlycontrolled,andarethereforeexpensive.Theydonotallowcomparisonofalargenumberofproducts.WHOhasproducedrecommendationsongoodpracticeformalariafieldtrialswhichshouldbefollowedtoimprovetherepeatabilityandqualityofresults(19).
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 25
11. resUlts
11.1. summaryInRound3oftheWHOMalariaRDTProductTesting,50productswereevaluatedagainstP. falciparumculturesamples,andallproceededtoevaluationagainstwild-typesamplescollectedfromparasitaemicpatientsfromthreecontinentsandalargepanelofparasite-negativesamples.Heatstabilitywasassessedattemperaturescommonlyencounteredinmalariaendemiccountries.Thirteenresearchinstituteshavebeenengagedineithersamplecollectionorsamplecharacterizationtoestablishtheevaluationpanels.BetweenApril2010andFebruary2011over60,000testswereperformedattheCDC.
Theresultsof theevaluationreveal thefollowingkeyoutcomes:
i) TheoverallrangeofresultsincludingPDS[formerly‘DetectionRate’],positivityrate,false-positiveratesandheatstability,weresimilartothosereportedinRound1andRound2 (3,4).However,overallP.falciparumandP. vivaxPDSmeanandmedianwerehigheragainstthelowparasitedensitysamplescomparedtoearlierrounds.
ii) AnumberofRDTsdemonstratedconsistentdetectionofmalariaatlowparasitedensities(200parasites/µl),havelowfalse-positiverates,arestableattropicaltemperatures,arerelativelyeasytouse,andcandetectP. falciparum,P. vivaxinfections,orboth,addingtothenumberofavailablewell-performingtestsincludedinRounds1and2.
iii) Performancebetweenproductsvariedwidelyatlowparasitedensity(200parasites/µl);however,themajorityofproductsshowedahighlevelof P. falciparumand P. vivaxdetectionat2000(or5000)parasites/µl.
iv) P. falciparumteststargetingHRP2antigendemonstratedthehighestPDSforP. falciparum,andhadahigheraveragePDSthanteststargetingpLDH,buttherewassomeoverlap.
v) SeveralcombinationtestsachievedPDSinthehighpartoftherangeforbothP. falciparum andP. vivax.
vi) Testperformancevariedbetweenlotsofsomeproducts.
Tables3and4summarizetheperformanceofmalariaRDTsagainstP. falciparumculturedparasitesandbloodcontainingwild-typeP. falciparumandP. vivaxparasitesandPlasmodiumspp.negativesamples.Dataiscolourcodedaccordingtoarbitrarycategories,toeasetheinterpretationofresults,andthesedonotimplylimitsofacceptableorunacceptableperformance.DetailedinformationpertainingtoproducttestingPhase1andPhase2resultsisincludedinAnnex3andAnnex4,respectively.AgraphicalrepresentationofthisdatafollowsinFigures7-15.
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)26 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 27
Tabl
e 3:
Sum
mar
y Ph
ase
1 pe
rfor
man
ce o
f 50
mal
aria
RDT
s ag
ains
t 20
cul
ture
d P.
fal
cipa
rum
line
s at
low
(20
0) a
nd h
igh
(200
0) p
aras
ite
dens
ities
(pa
rasi
tes/
µl)
Prod
uct
Cata
logu
e nu
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)26 Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 27
Prod
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Cata
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nly
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t min
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dica
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ctio
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Dete
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te (%
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Fals
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)28
Tabl
e 4:
Sum
mar
y Ph
ase
2 pe
rfor
man
ce o
f 50
mal
aria
RDT
s ag
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t w
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Prod
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Cata
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False
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200
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Pf s
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Pf s
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Fals
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Fals
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Fals
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Fals
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 29
Prod
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d
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)30
11.2. phase 1 - p. falciparum culture panelThemajority(94%)oftestsconsistentlydetected≥95%ofP. falciparumculturedparasitesathighparasitedensities(2000(or5000)parasites/µl);however,thepaneldetectionscorewashighlyvariable(0-100%)atlowparasitedensities(200parasites/µl).Atlowparasitedensities,theproductswiththehighestPDStargetedHRP2(Figure7).AllproductshadaPDS≥80%onhighparasitedensitysamplesandtherefore,proceededontoPhase2.
Figure 7: Phase 1 P. falciparum panel detection score of malaria RDTs at low (200) and high (2000) parasite densities (parasites/µl) according to target antigen type (HRP2 or pLDH)
a 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 Refer to TableA3.1 for individual panel detection scores for HRP2 and pf-pLDH test lines
res
Ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 31
11.3. phase 2 - Wild-type p. falciparum and p. vivax and plasmodium spp. negative samples 11.3.1. p. falciparum detectionAll 50 products inRound3were designed to detectP. falciparum.ComparedtotheP. falciparumculturedparasitepanel,P. falciparumPDSandpositivityratesofwild-typesamplesweregenerallyhigher,reflectingtheincreased
antigencontentofwild-typesamples.AsinPhase1,themajorityoftests(45;90%)hadapaneldetectionscore≥95%ofP. falciparumsamplesathighparasitedensitiesbutonly5tests(10%)hadthishighaPDSatlowparasitedensity(200parasites/µl).AlloftheseproductstargetedHRP2.AllfifteenproductsspecificforP. falciparumaloneachievedPDSof≥50%againstlowparasitedensitysamples(Figure8).
Figure 8: Phase 2 P. falciparum panel detection score of malaria RDTs at low (200) and high (2000a) parasite density (parasites/µl) according to target antigen type (HRP2 or pLDH)b
a 8 (8%) of the 99 P. falciparum dilution samples sets were 200 and 5000 parasites/µl and 2 (6%) of the 35 P. vivax dilution sample sets were 200 and 5000 parasites/µl b Phase 2 evaluation panel consisted of 99 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; c A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive; d Refer to Table4 for individual panel detection scores for HRP2 and pf-pLDH test lines
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)32
11.3.2. p. vivax detection Figure9illustrates,thatofthe35productsdesignedtodetectP. vivaxmostdetectedhighparasitedensities(2000(or5000)parasites/µl)consistently,andseveralachievedahighPDSagainst200parasite/µLsamples.However,theoveralldetectionofthelowparasitedensitywild-typeP. vivaxsampleswaslowerthanthatforP. falciparum.Atlowparasitedensities(200parasite/µL),onlysevenproducts(20%)hadpaneldetectionscores≥90%and18and12productshadaPDSof≥50%and≥75%,respectively.(Table4)
Figure 9: Phase 2 P. vivax panel detection score of malaria RDTs at low (200) and high (2000a) parasite densities (parasites/µl) according to target antigen type (aldolase, pLDH)b
2000 (pLDH)
200 (pLDH)
2000 (Aldolase)
200 (Aldolase)
a 2 (6%) of the 35 P. vivax dilution sample sets were 200 and 5000 parasites/µl; b 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; c A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive
res
Ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 33
11.3.3. combined detection of p. falciparum and p. vivax Consideringthe32combinationtests,14(44%)hadaPDSof≥50%and8(25%)hadaPDSof≥75%forbothP. falciparumandP. vivaxatthelowparasitedensity(200parasites/µl)(Table4).Severalperformedwellathighparasitedensities.Twoofthethreepan-specificonlytestshadsubstantiallybetterpaneldetectionscoresforP. vivax than P. falciparum, particularlyagainstlowparasitedensitysamples.
11.3.4. p. falciparum and p. vivax positivity rate InadditiontothePDS,thepositivityratewasalsomeasured.ThisputsasidetestandlotdifferencescapturedinthePDSandmeasuresthetotalnumberoftimesatestreturnedapositiveresult.Asexpected,positivityrateswerehigherthanPDSbutmirroredPDSagainstwild-typeP. falciparumandP. vivaxsamples(Figures10and11).
Figure 10: Phase 2 P. falciparum panel detection score and positivity rate at 200 parasites/µla
Pan
el D
etec
tio
n S
core
b/P
osi
tivi
ty r
atec (%
)
Positivity rate (pLDH)
Panel Detection Score (pLDH)
Positivity rate (HRP2)Panel Detection Score (HRP2)
a Phase 2 evaluation panel consisted of 99 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/total number of times tested; d Refer to Table 4 for individual panel detection scores for HRP2 and pf-pLDH test lines
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)34
11.3.5. band intensity AlthoughRDTsarenotquantitative,techniciansdidgradepositiveresultsaccordingtoastandardcolourchartandmeanbandintensity(forpositiveresults)wascalculated(Annex4-TablesA4.2,A4.3).Therewasapositivecorrelationbetweenpaneldetectionscoreandbandintensity;suggestingthat,asexpected,strongtestbandsareinterpretedmorereliably.
Figure 11: Phase 2 P. vivax panel detection score and positivity rate at 200 parasites/µla
Pan
el D
etec
tio
n S
core
b/P
osi
tivi
ty r
atec (%
)
Positivity rate (pLDH)
Panel Detection Score (pLDH)
Positivity rate (Aldolase)
Panel Detection Score (Aldolase)
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 minimum specified reading time, are positivec The total number of times a test returned a positive result/total number of times tested
res
Ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 35
11.3.6. false-positive rates Overallfalse-positiverateswerelow,withonlysixtestshavingrates>10%onclean-negativesamples,onanytestline(Figures12,13).Highfalse-positiverateswereseenwithsometestsagainstparasite-negativebloodwithallfourimmunologicalbloodabnormalities,inthepanelincludingRPR,Rheumatoidfactor,anti-DNAantibodyandhumananti-mouseantibodysamples.However,samplesizesweresmall.
Fordetailedinformationregardingthebloodabnormalityorpathogenthatgeneratedfalse-positiveresultsforaspecificproductrefertoAnnex4(TablesA4.8,A4.9).
Importantly,therewasnocleartrendofhigherfalse-positiveratesfortestswithhigherPDS,indicatingthattherewasnotacleartrade-offbetweensensitivityandspecificityoftestsatthesedetectionthresholds(Figures14,15).
Figure 12: Phase 2 P. falciparum (P. falciparum test line) false positive rate against clean negative samplesa
a Phase 2 evaluation panel included 100 Plasmodium spp. negative samples of which 50 were clean negatives from healthy volunteers with no known current illness or blood abnormality;
b Refer to Table A4.7 for individual false positive rates for HRP2 and pf-pLDH test lines
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)36
Figure 13: Phase 2 Plasmodium spp. (pan or P. vivax test line) false positive rate against clean negativesa
a Phase 2 evaluation panel included 100 Plasmodium spp. negative samples of which 50 were clean negatives, from healthy volunteers with no known current illness or blood abnormality
Figure 14: Phase 2 P. falciparum false positive ratea versus P. falciparum panel detection scoreb at low (200) parasite density (parasites/µl)
Fal
se p
osi
tive
rate
(%)
P. falciparum PDS at 200 parasites/µla False positive rate is on clean negatives, onlyb A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive.
res
Ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 37
Figure 15: Phase 2 P. vivax false positive ratea versus P. vivax panel detection scoreb at low (200) parasite density (parasites/µl)
Fal
se p
osi
tive
rate
(%)
P. vivax PDS at 200 parasites/µla False positive rate is on clean negatives, onlyb A sample is considered detected only if all RDTs from both lots read by the first technician, at minimum specified reading time, are positive.
12. Heat stabilitY
AsingleP. falciparumculturesamplewasusedastherefer-encesampleforheatstabilitytesting.Variationsinbaselineperformancereflectinter-testvariationasthesampleat200parasites/µlwasatthelimitofdetectionofsomeproducts.
Severalproductswerestable,meaningthattheydetectedaP. falciparumculturedsamplethesamenumberoftimesatbaselineand following incubation for twomonths(75%humidity)at4°C,35°Cand45°C.(Table5).DetailedresultsarepresentedinAnnex4(TablesA4.11-A4.13a)andinFigures16-23,theresultsofbothlotsarecombined(maximumscore30;15testsperlotagainst200parasites/µl;maximumscore10;5testsperlotagainst2000parasites/µl).
Overall, products showed greater stability againstsampleswithhigh(2000parasites/µl)comparedtolow
(200parasites/µl)parasitedensities,Figures16,18,20,22andFigures17,19,21,23,respectively,assmalldeteriora-tionsatthesehighparasitedensitieswillnotbeapparent.Inseveralcasesproductswhichhadbase-linepositivitylessthan100%showedunpredictablevariationinpositivityratesonsubsequenttestingaftertwomonths,consistentwithtestlinesontheborderlineofvisibility.Sometestlinesshowedahighdegreeofstabilityat35°Cbutlosttheabilitytodetectantigenafterincubationat45°C.Asinpreviousrounds,someproductsshowedanimprovedperformancewithincubation(Figures17,18,20,2223).Overall,thestabilityofpLDH-detectingtestlineswaslowerthanthatforHRP2-detectingtestlines,butsometestsdidexhibitgoodstabilityofpLDHtestlines,indicatingheat-stablecombinationtests.
Thesummaryresultsofheat/thermalstability testingarepresentedinTable5.Notethat,asaculture-derivedP. falciparum sampleisusedforheatstabilitytesting,itisnotpossibletoprovidestabilitydataontestlinesthatdetectonlynon-P. falciparumparasites.Suchdata,andconfirmatorydataonthestabilityofrecentproductionlotsofalltests,shouldbeobtainedfrommanufacturersduringproductselectionprocesseswhenprocuringRDTs(Annex5a).
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)38
Tabl
e 5:
Hea
t st
abili
ty t
estin
g re
sult
s fo
r 50
mal
aria
RDT
s on
a c
ultu
red
P. f
alci
paru
m s
ampl
e at
low
(20
0) a
nd h
igh
(200
0) p
aras
ite
dens
ity
(par
asit
es/µ
l). P
ositi
vity
rat
e at
bas
elin
e, a
nd a
fter
60
days
in
cuba
tion
at 3
5°C
and
45°C
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
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
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
(
max
. 30)
Num
ber
of t
ests
pos
itive
(m
ax. 3
0)N
umbe
r of
tes
ts p
ositi
ve
(max
. 10)
Num
ber
of t
ests
pos
itive
(m
ax. 1
0)Lo
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
dPf
onl
yAd
vanc
ed Q
ualit
y™ O
ne S
tep
Mal
aria
P.f
Test
ITP1
1002
TC40
InTe
c Pr
oduc
ts, I
nc.
30.0
30.0
30.0
N/A
N/A
N/A
10.0
10.0
10.0
N/A
N/A
N/A
BION
OTE
MAL
ARIA
P.f.
Ag
Rapi
d Te
st K
it RG
19-1
1Bi
onot
e,In
c.30
.030
.026
.0N
/AN
/AN
/A10
.09.
08.
0N
/AN
/AN
/A
Clea
rvie
w®
Mal
aria
P.f.
VB
01Vi
sion
Bio
tech
(Pty
) Ltd
30.0
30.0
30.0
N/A
N/A
N/A
10.0
10.0
10.0
N/A
N/A
N/A
Core
™ M
alar
ia P
f M
AL-1
9002
0Co
re D
iagn
ostic
s30
.030
.029
.0N
/AN
/AN
/A10
.010
.010
.0N
/AN
/AN
/A
ICT
Diag
nost
ics
Mal
aria
P.f.
M
L01
ICT
Diag
nost
ics
30.0
30.0
30.0
N/A
N/A
N/A
10.0
10.0
10.0
N/A
N/A
N/A
IMM
UN
OQU
ICK
CON
TACT
falc
ipar
um
0519
K25
Bios
ynex
30.0
30.0
30.0
N/A
N/A
N/A
10.0
10.0
10.0
N/A
N/A
N/A
Nan
oSig
n M
alar
ia P
f Ag
RMAF
10Bi
olan
d, L
td29
.030
.030
.0N
/AN
/AN
/A10
.010
.010
.0N
/AN
/AN
/A
One
Step
Mal
aria
P.F
Tes
t (ca
sset
te)
5223
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.19
.00.
00.
0N
/AN
/AN
/A10
.010
.010
.0N
/AN
/AN
/A
One
Step
Mal
aria
P.f
Test
W
37-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.30
.028
.027
.0N
/AN
/AN
/A10
.010
.010
.0N
/AN
/AN
/A
OnSi
te P
f Ag
Rapi
d Te
st
R011
4CCT
K Bi
otec
h, In
c.29
.030
.030
.0N
/AN
/AN
/A10
.010
.010
.0N
/AN
/AN
/A
Para
chec
k® P
f Dev
ice-
Rap
id te
st fo
r P. f
alci
paru
m
Mal
aria
Ver
. 3
3030
1025
Orch
id B
iom
edic
al S
yste
ms
30.0
30.0
30.0
N/A
N/A
N/A
10.0
10.0
10.0
N/A
N/A
N/A
Para
chec
k® P
f Dip
stic
k- R
apid
test
for P
. fal
cipa
rum
M
alar
ia V
er. 3
30
3020
25Or
chid
Bio
med
ical
Sys
tem
s30
.030
.030
.0N
/AN
/AN
/A10
.010
.010
.0N
/AN
/AN
/A
Para
HIT
® -
f (De
vice
) 55
IC10
2-50
Span
Dia
gnos
tics
Ltd.
30.0
29.0
30.0
N/A
N/A
N/A
10.0
10.0
9.0
N/A
N/A
N/A
Para
HIT
® -f
(Dip
stic
k)
55IC
101-
50Sp
an D
iagn
ostic
s Lt
d.30
.030
.017
.0N
/AN
/AN
/A10
.010
.010
.0N
/AN
/AN
/A
SD B
IOLI
NE
Mal
aria
Ag
P.f.
(HRP
2/pL
DH)a
05FK
90St
anda
rd D
iagn
ostic
s In
c.30
.030
.030
.0N
/AN
/AN
/A10
.010
.010
.0N
/AN
/AN
/A
Pf a
nd P
anAB
ON M
alar
ia P
an/P
.f. R
apid
Tes
t Dev
ice
IMA-
B402
ABON
Bio
phar
m (H
angz
hou)
Co.
Ltd
.30
.024
.027
.00.
00.
00.
010
.010
.010
.00.
00.
00.
0
BION
OTE
MAL
ARIA
P.f.
& P
an A
g Ra
pid
Test
Kit
RG19
-08
Bion
ote,
Inc.
30.0
30.0
29.0
0.0
0.0
0.0
10.0
10.0
10.0
10.0
10.0
9.0
Care
Star
t™ M
alar
ia/P
regn
ancy
Com
bo
(pLD
H/H
RP2/
HCG
) G
O221
Acce
ss B
io, I
NC.
30.0
30.0
30.0
30.0
30.0
30.0
10.0
10.0
10.0
10.0
10.0
10.0
Care
Star
t™ M
alar
ia p
LDH
3 L
ine
Test
G
O121
Acce
ss B
io, I
NC.
30.0
30.0
30.0
30.0
30.0
30.0
10.0
10.0
10.0
10.0
10.0
10.0
Care
Star
t™ M
alar
ia S
cree
n G
O231
Acce
ss B
io, I
NC.
30.0
30.0
28.0
30.0
30.0
28.0
10.0
10.0
10.0
10.0
10.0
10.0
Clea
rvie
w®
Mal
aria
Com
bo
VB11
Visi
on B
iote
ch (P
ty) L
td30
.030
.030
.00.
00.
00.
010
.010
.010
.09.
02.
00.
0
Clea
rvie
w®
Mal
aria
Dua
l Tes
t Dev
ice
VB20
Visi
on B
iote
ch (P
ty) L
td30
.030
.029
.00.
00.
00.
010
.010
.010
.05.
09.
02.
0
diag
nost
icks
MAL
ARIA
(Pan
/Pf)
Cass
ette
M
PNFW
BC10
07.4
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
30.0
30.0
29.0
0.0
0.0
0.0
10.0
10.0
10.0
10.0
9.0
9.0
ICT
Diag
nost
ics
Mal
aria
Com
bo
ML0
2IC
T Di
agno
stic
s30
.030
.029
.00.
00.
00.
010
.010
.09.
09.
03.
00.
0
ICT
Diag
nost
ics
Mal
aria
Dua
l M
L03
ICT
Diag
nost
ics
30.0
30.0
28.0
0.0
0.0
0.0
10.0
10.0
10.0
10.0
8.0
0.0
IMM
UN
OQU
ICK
CON
TACT
MAL
ARIA
+4
0525
K25
Bios
ynex
30.0
30.0
30.0
0.0
0.0
0.0
10.0
10.0
10.0
5.0
5.0
10.0
Mal
aria
Pan
Tes
t M
AL-W
23N-
001
Dim
a •
Gese
llsch
aft f
ür D
iagn
ostik
a m
bH18
.010
.07.
04.
016
.012
.010
.010
.09.
01.
06.
04.
0
Mal
aria
pf (
HRP
II) /
(PAN
-pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
MFV
-124
RAZ
OG, I
nc.
30.0
30.0
30.0
0.0
0.0
0.0
10.0
10.0
10.0
0.0
0.0
0.0
res
Ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 39
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
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
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
(
max
. 30)
Num
ber
of t
ests
pos
itive
(m
ax. 3
0)N
umbe
r of
tes
ts p
ositi
ve
(max
. 10)
Num
ber
of t
ests
pos
itive
(m
ax. 1
0)Lo
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
dM
alar
ia p
f (pL
DH) /
PAN
-pLD
H T
est D
evic
e M
FV-1
24AZ
OG, I
nc.
1.0
0.0
0.0
0.0
0.0
0.0
4.0
1.0
0.0
0.0
0.0
0.0
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
29.0
30.0
29.0
0.0
0.0
2.0
10.0
10.0
10.0
10.0
10.0
10.0
Nan
oSig
n M
alar
ia P
f/Pa
n Ag
RM
AP10
Biol
and,
Ltd
30.0
30.0
30.0
0.0
0.0
0.0
10.0
10.0
9.0
0.0
0.0
0.0
Nan
oSig
n M
alar
ia P
f/Pv
Ag
-RM
AD10
Biol
and,
Ltd
0.0
0.0
0.0
0.0
0.0
0.0
2.0
0.0
0.0
0.0
0.0
0.0
One
Step
Mal
aria
P.f/
Pan
Test
W
56-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.14
.04.
08.
00.
011
.022
.010
.010
.010
.07.
08.
010
.0
OnSi
te P
f/Pa
n M
alar
ia A
g Ra
pid
Test
R0
113C
CTK
Biot
ech,
Inc.
30.0
30.0
30.0
1.0
20.0
25.0
10.0
10.0
10.0
10.0
10.0
8.0
OptiM
AL-I
T 71
0024
Diam
ed -
A D
ivis
ion
of B
io-R
ad0.
00.
00.
00.
00.
00.
010
.09.
00.
010
.09.
00.
0
Para
scre
en™
Dev
ice
- Ra
pid
test
for M
alar
ia P
an/P
f50
3100
25Ze
phyr
Bio
med
ical
Sys
tem
s30
.030
.030
.00.
00.
00.
010
.010
.010
.09.
010
.010
.0
SD B
IOLI
NE
Mal
aria
Ag
P.f/
Pan
05FK
60St
anda
rd D
iagn
ostic
s In
c.30
.029
.030
.00.
00.
00.
010
.010
.010
.010
.07.
09.
0
SD B
IOLI
NE
Mal
aria
Ag
05FK
40St
anda
rd D
iagn
ostic
s In
c.0.
00.
00.
00.
00.
00.
010
.08.
09.
08.
02.
09.
0
Sure
step
™ E
asy
Mal
aria
Pf/
Pan
Rapi
d Te
st D
evic
e IM
A-T4
02AC
ON B
iote
ch (H
angz
hou)
Co.
Ltd
.30
.030
.030
.00.
00.
00.
010
.010
.010
.00.
00.
00.
0
Pf a
nd P
vAd
vanc
ed Q
ualit
y™ O
ne S
tep
Mal
aria
P.f/
P.v
Tri-
Line
Test
IT
P110
03 T
C40
InTe
c Pr
oduc
ts, I
nc.
29.0
30.0
30.0
N/A
N/A
N/A
10.0
10.0
10.0
N/A
N/A
N/A
Adva
ntag
e M
alar
ia C
ard
IR21
1025
J. M
itra
& C
o. P
vt. L
td.
30.0
29.0
29.0
N/A
N/A
N/A
10.0
10.0
10.0
N/A
N/A
N/A
BION
OTE
MAL
ARIA
P.f.
& P
.v. A
g Ra
pid
Test
Kit
RG19
-12
Bion
ote,
Inc.
30.0
29.0
30.0
N/A
N/A
N/A
10.0
10.0
10.0
N/A
N/A
N/A
Core
™ M
alar
ia P
v/Pf
MAL
-190
022
Core
Dia
gnos
tics
30.0
30.0
30.0
N/A
N/A
N/A
10.0
10.0
10.0
N/A
N/A
N/A
Mal
aria
pf (
HRP
II) /
pv
(pLD
H) A
ntig
en D
etec
tion
Test
Dev
ice
MFV
-124
VAZ
OG, I
nc.
30.0
30.0
29.0
N/A
N/A
N/A
10.0
10.0
10.0
N/A
N/A
N/A
OnSi
te M
alar
ia P
f/Pv
Ag
Rapi
d Te
st
R011
2CCT
K Bi
otec
h, In
c.30
.030
.030
.0N
/AN
/AN
/A10
.010
.010
.0N
/AN
/AN
/A
Pf, P
an a
nd P
vCo
re™
Mal
aria
Pan
/Pv/
Pf
MAL
-190
026
Core
Dia
gnos
tics
30.0
30.0
30.0
0.0
0.0
0.0
10.0
9.0
10.0
8.0
5.0
7.0
diag
nost
icks
MAL
ARIA
(Pan
/Pv/
Pf) C
asse
tte
MPN
VFC1
007.
5SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s29
.030
.028
.00.
00.
00.
010
.010
.010
.07.
00.
05.
0
Pan
only
Clea
rvie
w®
Mal
aria
pLD
H
7088
4025
Orge
nics
Ltd
. (In
vern
ess
Med
ical
In
nova
tions
)N
/AN
/AN
/A29
.028
.030
.0N
/AN
/AN
/A10
.010
.010
.0
diag
nost
icks
MAL
ARIA
(Pan
) Cas
sett
e M
PNW
BC10
07.3
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
N/A
N/A
N/A
0.0
0.0
0.0
N/A
N/A
N/A
8.0
10.0
8.0
Para
bank
™ D
evic
e -
Rapi
d te
st fo
r Mal
aria
Pan
50
3010
25Ze
phyr
Bio
med
ical
Sys
tem
sN
/AN
/AN
/A0.
00.
00.
0N
/AN
/AN
/A9.
010
.010
.0
Pf: P
lasm
odiu
m fa
lcip
arum
Pv
: Pla
smod
ium
viv
ax
pan:
Pla
smod
ium
spec
ies
a Re
sults
pre
sent
ed in
the
tabl
e ar
e ba
sed
on s
tabi
lity
of a
pf t
est l
ine
(eith
er p
f-H
RP2
or p
f-pL
DH).
Resu
lts b
ased
on
stab
ility
of i
ndiv
idua
l tes
t lin
es o
n 20
0p/µ
l sam
ples
wer
e :
pf-p
LDH
(0/3
0 at
bas
elin
e an
d po
st 6
0 d
incu
batio
n at
35°
C, 4
5°C)
and
pf-
HRP
2 (3
0/30
at b
asel
ine
and
post
60
d in
cuba
tion
at 3
5°C,
45°
C)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)40
12.1. p. falciparum test lines
Figure 16: 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.
0
20
30
10
Baseline 35 °C 45 °C
No
. of
po
sitiv
e re
sults
fro
m t
wo
lots
a
a Maximum score is 30 (15 tests x 2 lots); b Refer to Table A4.11 for individual HRP2 and pf-pLDH test line performance
Figure 17: Heat stability of P. falciparum specific test line of P. falciparum tests against a high density P. falciparum sample (2000 parasites/µl). Positivity rate at baseline, and after 60 days incubation.
0
8
10
6
4
2
Baseline 35 °C 45 °C
No
. of
po
sitiv
e re
sults
fro
m t
wo
lots
a
a Maximum score is 10 (5 tests x 2 lots); b Refer to Table A4.12 for individual HRP2 and pf-pLDH test line performance
res
Ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 41
Figure 18: 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.
No
. of
po
sitiv
e re
sults
fro
m t
wo
lots
a
0
10
20
30
Baseline 35 °C 45 °C
a Maximum score is 30 (15 tests x 2 lots)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)42
Figure 19: 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.
No
. of
po
sitiv
e re
sults
fro
m t
wo
lots
a
Baseline 35 °C 45 °C0
8
10
6
4
2
a Maximum score is 10 (5 tests x 2 lots)
res
Ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 43
12.2. pan-specific test lines
Figure 20: Heat stability of pan-line of pan-specific tests against a low density P. falciparum sample (200 parasites/µl). Positivity rate at baseline, and after 60 days incubation.
No
. of
po
sitiv
e re
sults
fr
om
tw
o lo
tsa
Baseline 35 °C 45 °C0
30
20
10
a Maximum score is 30 (15 tests x 2 lots)
Figure 21: Heat stability of pan-line of pan-specific tests against a high density P. falciparum sample (2000 parasites/µl). Positivity rate at baseline, and after 60 days incubation.
No
. of
po
sitiv
e re
sults
fr
om
tw
o lo
tsa
Baseline 35 °C 45 °C0
10
8
6
4
2
a Maximum score is 10 (5 tests x 2 lots)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)44
Figure 22: 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
po
sitiv
e re
sults
fro
m t
wo
lots
a
0
20
30
10
Baseline 35 °C 45 °C
a Maximum score is 30 (15 tests x 2 lots)
res
Ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 45
Figure 23: 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.
No
. of
po
sitiv
e re
sults
fro
m t
wo
lots
a
Baseline 35 °C 45 °C0
10
8
6
4
2
a Maximum score is 10 (5 tests x 2 lots)
13. ease of Use description
Afterbecomingproficientatusingaproduct,twotechniciansjointlyproducedanagreedassessmentofproductusability.Theresults,whichconstituteadescriptionoftheproductwithemphasisonaspectsconsideredofimportancetoease-of-useinafieldsetting,arepresentedinTable6.Itisstronglyrecommendedthatease-of-useandscreeningformajortestanomaliesalsobeassessedduringproductselectionprocesseswhenprocuringRDTs(Annex5b).
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)46
Tabl
e 6:
Eas
e of
use
des
crip
tion
of m
alar
ia R
DTs
incl
uded
in R
ound
3: W
HO
Mal
aria
RDT
Pro
duct
Tes
ting
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
Bloo
d sa
fety
aIn
stru
ctio
n qu
ality
bCo
m-
bine
d sc
ore
(max
. 5)
Num
ber
of t
imed
st
eps
Tota
l tim
e to
re
sult
Bloo
d tr
ansf
er
devi
ce
Lang
uage
of
in
stru
ctio
n Ite
ms
incl
uded
in p
acka
gec
Mix
ing
wel
ls in
volv
ed
Retr
act-
able
ne
edle
St
rip
Expo
sed
Scor
e (m
ax. 3
) N
o di
agra
mDi
agra
m
of re
sult
Diag
ram
of
resu
lt
& m
etho
dSc
ore
(max
. 2)
Pf o
nly
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia P
.f Te
stIT
P110
02TC
40In
Tec
Prod
ucts
, Inc
.1
N/A
12
11
24
115
Pipe
tte
Engl
ish
Cass
ette
, Tra
nsfe
r Pip
ette
, Buf
fer,
Desi
ccan
t (n
on c
olor
cha
nge)
BION
OTE
MAL
ARIA
P.f.
Ag
Rapi
d Te
st K
it RG
19-1
1Bi
onot
e,In
c.1
N/A
12
11
24
120
Capi
llary
tu
beEn
glis
hCa
sset
te, C
apill
ary
Tube
s, Bu
ffer
, Des
icca
nt
(Non
-Col
or C
hang
e)
Clea
rvie
w®
Mal
aria
P.f.
VB
01Vi
sion
Bio
tech
(Pty
) Ltd
1N
/A1
21
12
41
15Pi
pett
e
Engl
ish,
Fr
ench
, Po
rtug
uese
, Sp
anis
h
Cass
ette
, Tra
nsfe
r Pip
ette
, Buf
fer,
Desi
ccan
t (c
olor
-Cha
nge)
Core
™ M
alar
ia P
f M
AL-1
9002
0Co
re D
iagn
ostic
s1
01
21
01
31
20lo
opEn
glis
hCa
sset
te, T
rans
fer L
oop,
Buf
fer,
Alco
hol
Swab
s, La
ncet
s, De
sicc
ant (
Colo
r-Ch
angi
ng)
ICT
Diag
nost
ics
Mal
aria
P.f.
M
L01
ICT
Diag
nost
ics
1N
/A1
21
12
41
15Pi
pett
eEn
glis
hCa
sset
te, T
rans
fer P
ipet
te, B
uffe
r, De
sicc
ant
(Col
or-C
hang
ing)
IMM
UN
OQU
ICK
CON
TACT
falc
ipar
um
0519
K25
Bios
ynex
1N
/A1
21
12
41
20N
/AEn
glis
hCa
sset
te, B
uffe
r, De
sicca
nt (N
on-C
olor
Cha
nge)
Nan
oSig
n M
alar
ia P
f Ag
RMAF
10Bi
olan
d, L
td1
01
21
12
41
15Ca
pilla
ry
tube
Engl
ish
Cass
ette
, Cap
illar
y Tu
bes,
Buff
er, L
ance
t, De
sicc
ant (
non
Colo
r Cha
nge)
One
Step
Mal
aria
P.F
Tes
t (ca
sset
te)d
5223
52Bl
ue C
ross
Bio
-Med
ical
(B
eijin
g) C
o., L
td.
1N
/A1
2N
/AN
/AN
/AN
/AN
/A1
15N
/Ana
Cass
ette
, Buf
fer,
Desic
cant
(Non
-Col
or C
hang
e)
One
Step
Mal
aria
P.f
Test
W
37-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.1
11
31
12
51
15Pi
pett
eEn
glis
hCa
sset
te, T
rans
fer P
ipet
tes,
Lanc
et (r
etra
ctab
le
Nee
dle)
, Alc
ohol
Sw
ab, B
uffe
r, De
sicc
ant
(col
or-c
hang
e)
OnSi
te P
f Ag
Rapi
d Te
st
R011
4CCT
K Bi
otec
h, In
c.0
N/A
11
11
23
130
Pipe
tte
Engl
ish
Cass
ette
, Tra
nsfe
r Pip
ette
s, Bu
ffer
, Des
icca
nt
(Non
-Col
or C
hang
e)Pa
rach
eck®
Pf D
evic
e- R
apid
test
for
P. fa
lcip
arum
Mal
aria
(Ver
. 3)
3030
1025
Orch
id B
iom
edic
al S
yste
ms
10
12
10
13
120
loop
Engl
ish
Cass
ette
, Tra
nsfe
r Loo
p, L
ance
t, Al
coho
l Sw
ab,
Buff
er, D
esic
cant
(Non
-Col
or C
hang
e)Pa
rach
eck®
Pf D
ipst
ick-
Rap
id te
st fo
r P.
falc
ipar
um M
alar
ia (V
er. 3
) 30
3020
25Or
chid
Bio
med
ical
Sys
tem
s1
00
11
01
21
20lo
opEn
glis
hDi
pstic
k, T
rans
fer L
oop,
Lan
cet,
Alco
hol S
wab
, Bu
ffer
, Des
icca
nt (N
on-C
olor
Cha
nge)
Para
HIT
® -
f (De
vice
) 55
IC10
2-50
Span
Dia
gnos
tics
Ltd.
10
12
11
24
130
Capi
llary
tu
beEn
glis
hCa
sset
te, C
apill
ary
Tube
s, La
ncet
, Alc
ohol
Sw
abs,
Buff
er, D
esic
cant
(Non
-Col
or-C
hang
e)
Para
HIT
® -f
(Dip
stic
k)
55IC
101-
50Sp
an D
iagn
ostic
s Lt
d.1
00
11
12
31
30Ca
pilla
ry
tube
Engl
ish
Dips
tick,
Capi
llary
Tub
es, L
ance
t, Al
coho
l Sw
abs,
Buff
er, D
esic
cant
(Non
-Col
or-C
hang
e)
SD B
IOLI
NE
Mal
aria
Ag
P.f.
(HRP
2/pL
DH)f
05FK
90St
anda
rd D
iagn
ostic
s In
c.1
N/A
12
11
24
115
Pipe
tte
Engl
ish
Cass
ette
, Tra
nsfe
r Pip
ette
, Buf
fer D
esic
cant
(N
on C
olor
Cha
nge)
Pf a
nd P
an
ABON
Mal
aria
Pan
/P.f.
Rap
id T
est D
evic
e IM
A-B4
02AB
ON B
ioph
arm
(Han
gzho
u)
Co. L
td.
1N
/A1
21
12
41
15Pi
pett
eEn
glis
hCa
sset
te, T
rans
fer P
ipet
te, B
uffe
r Des
icca
nt
(Non
Col
or C
hang
e)
BION
OTE
MAL
ARIA
P.f.
& P
an A
g Ra
pid
Test
Kit
RG19
-08
Bion
ote,
Inc.
1N
/A1
21
12
41
20Ca
pilla
ry
tube
Engl
ish
Cass
ette
, Cap
illar
y Tu
bes,
Buff
er, D
esic
cant
(N
on-C
olor
Cha
nge)
Care
Star
t™ M
alar
ia/P
regn
ancy
Com
bo
(pLD
H/H
RP2/
HCG
) G
O221
Acce
ss B
io, I
nc.
10
12
11
24
120
Pipe
tte
Engl
ish
Cass
ette
, Tra
nsfe
r Pip
ette
, Buf
fer,
Alc.
Sw
abs,
Lanc
ets,
Desi
ccan
t (no
n co
lor C
hang
e)
Care
Star
t™ M
alar
ia p
LDH
3 L
ine
Test
G
O121
Acce
ss B
io, I
nc.
10
12
11
24
120
Pipe
tte
Engl
ish
Cass
ette
, Tra
nsfe
r Pip
ette
, Buf
fer,
Alc.
Sw
abs,
Lanc
ets,
Desi
ccan
t (no
n co
lor C
hang
e)
Care
Star
t™ M
alar
ia S
cree
n G
O231
Acce
ss B
io, I
nc.
10
12
11
24
120
Pipe
tte
Engl
ish
Cass
ette
, Tra
nsfe
r Pip
ette
, Buf
fer,
Alc.
Sw
abs,
Lanc
ets,
Desi
ccan
t (no
n co
lor C
hang
e)
Clea
rvie
w®
Mal
aria
Com
bo
VB11
Visi
on B
iote
ch (P
ty) L
td1
N/A
12
11
24
115
Pipe
tte
Engl
ish,
Fr
ench
, Po
rtug
ese,
Sp
anis
h
Cass
ette
, Tra
nsfe
r Pip
ette
, Buf
fer,
Desi
ccan
t (c
olor
-Cha
nge)
res
Ult
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 47
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
Bloo
d sa
fety
aIn
stru
ctio
n qu
ality
bCo
m-
bine
d sc
ore
(max
. 5)
Num
ber
of t
imed
st
eps
Tota
l tim
e to
re
sult
Bloo
d tr
ansf
er
devi
ce
Lang
uage
of
in
stru
ctio
n Ite
ms
incl
uded
in p
acka
gec
Mix
ing
wel
ls in
volv
ed
Retr
act-
able
ne
edle
St
rip
Expo
sed
Scor
e (m
ax. 3
) N
o di
agra
mDi
agra
m
of re
sult
Diag
ram
of
resu
lt
& m
etho
dSc
ore
(max
. 2)
Clea
rvie
w®
Mal
aria
Dua
l Tes
t Dev
ice
VB20
Visi
on B
iote
ch (P
ty) L
td1
N/A
12
11
24
120
Pipe
tte
Engl
ish
Cass
ette
, Tra
nsfe
r Pip
ette
, Buf
fer,
Desi
ccan
t (c
olor
-Cha
nge)
diag
nost
icks
MAL
ARIA
(Pan
/Pf)
Cass
ette
M
PNFW
BC10
07.4
SSA
Diag
nost
ics
& B
iote
ch
Syst
ems
10
12
10
13
120
Loop
Engl
ish
Cass
ette
, Tra
nsfe
r Loo
p, L
ance
t, Al
coho
l Sw
ap,
Buff
er, D
esic
cant
(Non
-col
or C
hang
e)
ICT
Diag
nost
ics
Mal
aria
Com
bo
ML0
2IC
T Di
agno
stic
s1
N/A
12
11
24
115
Pipe
tte
Engl
ish
Cass
ette
, Tra
nsfe
r Pip
ette
, Buf
fer,
Desi
ccan
t (C
olor
-Cha
ngin
g)
ICT
Diag
nost
ics
Mal
aria
Dua
l M
L03
ICT
Diag
nost
ics
1N
/A1
21
12
41
20Pi
pett
eEn
glis
hCa
sset
te, T
rans
fer P
ipet
te, B
uffe
r, De
sicc
ant
(Col
or-C
hang
ing)
IMM
UN
OQU
ICK
CON
TACT
MAL
ARIA
+4
0525
K25
Bios
ynex
1N
/A1
21
12
41
20N
/AEn
glis
hCa
sset
te, B
uffe
r, De
sicca
nt (N
on-C
olor
Cha
nge)
Mal
aria
Pan
Tes
t M
AL-
W23
N-0
01Di
ma
• G
esel
lsch
aft f
ür
Diag
nost
ika
mbH
1N
/A1
21
12
41
15Pi
pett
eEn
glis
hCa
sset
te, B
uffe
r, Tr
ansf
er P
ipet
te, D
esic
cant
(N
on-C
olor
Cha
nge)
Mal
aria
pf (
HRP
II) /
(PAN
-pLD
H) A
ntig
en
Dete
ctio
n Te
st D
evic
e M
FV-1
24R
AZOG
, Inc
.1
N/A
12
11
24
120
N/A
Engl
ish
Cass
ette
, Buf
fer,
Desi
ccan
t (N
on c
olor
cha
nge)
Mal
aria
pf (
pLDH
) / P
AN-p
LDH
Tes
t Dev
ice
MFV
-124
AZOG
, Inc
.1
N/A
12
11
24
120
N/A
Engl
ish
Cass
ette
, Buf
fer,
Desi
ccan
t (N
on c
olor
cha
nge)
Mal
asca
n™ D
evic
e -
Rapi
d te
st fo
r Mal
aria
Pf
/Pan
50
4020
25Ze
phyr
Bio
med
ical
Sys
tem
s1
01
21
01
31
20Lo
opEn
glis
hCa
sset
te, T
rans
fer L
oop,
Lan
cet,
Alco
hol S
wab
, Bu
ffer
, Des
icca
nt (c
olor
-cha
nge)
Nan
oSig
n M
alar
ia P
f/Pa
n Ag
RM
AP10
Biol
and,
Ltd
10
12
11
24
115
Capi
llary
tu
beEn
glis
hCa
sset
te, C
apill
ary
Tube
s, Bu
ffer
, Lan
cet,
Desi
ccan
t (no
n Co
lor C
hang
e)
Nan
oSig
n M
alar
ia P
f/Pv
Ag
RMAD
10Bi
olan
d, L
td1
01
21
12
41
15Ca
pilla
ry
tube
Engl
ish
Cass
ette
, Cap
illar
y Tu
bes,
Buff
er, L
ance
t, De
sicc
ant (
non
Colo
r Cha
nge)
One
Step
Mal
aria
P.f/
Pan
Test
W
56-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.1
11
31
12
51
15Pi
pett
eEn
glis
hCa
sset
te, T
rans
fer P
ipet
tes,
Lanc
et (r
etra
ctab
le
Nee
dle)
, Alc
ohol
Sw
ab, B
uffe
r, De
sicc
ant
(col
or-c
hang
e)
OnSi
te P
f/Pa
n M
alar
ia A
g Ra
pid
Test
R0
113C
CTK
Biot
ech,
Inc.
0N
/A1
11
12
31
30Pi
pett
eEn
glis
hCa
sset
te, T
rans
fer P
ipet
tes,
Buff
er, D
esic
cant
(N
on-C
olor
Cha
nge)
OptiM
AL-I
T 71
0024
Diam
ed -
A D
ivis
ion
of
Bio-
Rad
00
11
10
12
420
Capi
llary
tu
be
Engl
ish,
Fr
ench
, Po
rtug
uese
, Sp
anis
h ,G
erm
an,
Italia
n
Cass
ette
, Cap
illar
y Tu
bes,
Buff
er, A
lcoh
ol S
wab
s, La
ncet
, Des
icca
nt (N
on-C
olor
Cha
nge)
, Cov
er
Para
scre
en™
Dev
ice
- Ra
pid
test
for M
alar
ia
Pan/
Pf50
3100
25Ze
phyr
Bio
med
ical
Sys
tem
s1
01
21
01
31
20Lo
opEn
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)48
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Tabl
e 6
(con
tinue
d)
dis
cUss
ion
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 49
14. discUssion of keY findings
Thisreportdescribestheperformanceofmanyoftheavailablemalariaantigen-detectingRDTsmanufacturedundertheISO13485:2003qualitystandard.MalariaRDTshavethepotentialtoprovideahugestepforwardinthemanagementoffebrileillnessinmalaria-endemicareas.Tobeusefulinthiscontext,malariaRDTsmusthaveadequate:i. sensitivity,todetectnearlyallclinically-significantcases
ofmalaria;
ii. specificity,toaccuratelydiscriminatenon-malarialfebrileillnessfrommalaria,toensureappropriatemanagementandaccuratediseasemonitoring;
iii. stability,foraccuracytobemaintainedaftertransportandstorageinambientconditions;
iv. easeofuseandsafety,toallowsafeandcorrectprepara-tion,andcorrectinterpretationofresults.
InordertoassistNationalMalariaControlProgrammesandotherprocurementagenciesintheselectionofproductsappropriatetotheirneeds,malariaRDTswereevaluatedintermsofthesefourmajorrequirements.ThepanelusedsuccessfullydiscriminatedbetweentheRDTsevaluated,showingaconsiderablerangeofperformance.Importantly,anumberofproductsdemonstratedahighrateofantigendetectioncombinedwithalowfalse-positiverateandgoodheat(thermal)stability,attributesessentialiftheyaretobereliedonasabasisformalariatreatmentdecisionsinmostendemicpopulations.DeservingspecialnoteinRound3isthemarkedimprovementinPDSofmanyproductsre-submittedforevaluationfrompreviousrounds(TableS1,S3).Againstthe200parasites/µlpanels,themeanandmedianPDSofthe23re-submittedproductsrosefrom61.3%to74.7%and63.1%to83.8%,respectivelyforP. falciparumdetection.ForP. vivax,themeanandmedianrosefrom31.1%to60.7%andfrom30.0%to62.9%,respectively.Theresultsforre-submittedproductsinRound3replacethoseofpreviousrounds.Theprogrammeadherestoaworkingdefinitionof‘product’whichlaysoutspecificconditions/modificationsthatdenoteachangeinproduct.
Overall,themeanPDSforRound3washigherthanpreviousroundswhile,importantly,themeanfalsepositiveraterosefrom3.5%and4.3%inRounds1and2,respectively,to5.9%;however,themedianfellfrom1.8%and2.0%(Rounds1and2)to1.0%inRound3.Overall,thisindicatesanimprovementintestqualityassociatedwiththeperiodoftheWHO-FINDRDTEvaluationProgramme.
TheprincipalresultsinthisreportarepresentedinTables3and4.ThetablesgrouptheRDTsbytype,dependingonwhattheyaimtodetect,e.g.P. falciparumonly,P. falciparumandnon-falciparumspecies,non-P. falciparum species only, orallmalariaspecieswithoutdiscrimination.Paneldetectionscores
atbothhighandlowparasiteconcentrationsarepresented,asarefalse-positiverates,andthepercentageofinvalidtestresults.Testsineachcategoryarelistedalphabetically,buttheresultsarecolour-codedtoassistthereaderinquickinterpretationofthedata.Thesecolourcodesareintendedtobeusedtoquicklycompareperformanceinthedifferentcategoriesandnotasperformancecut-offstoguidetestselectionorprocurement.WHOrecommendationsforprocurementshouldbereferredtoregardingthesecriteria22.Whenchoosinganappropriateproduct,itisimportanttoalsoreviewthestabilityresults(Table5)inthecontextoftheexpectedconditionsoftransportandstorageoftheRDTsinthefield.
Thisevaluationisperformedagainstastandardizedpanelofcultured P. falciparum andfrozenbloodsamplesbyexpe-riencedtechniciansinaresearchlaboratory,andisnotthereforeafieldevaluationofRDTaccuracyinaspecificepidemiologicalcontextinthehandsofintendedusers.Thepanelisdesignedtomimicfreshbloodsamplesfromactualcasesascloselyaspossible,whileallowingdirectcomparisonofalargenumberofproductssimultaneouslyinamannerthatcontrolsforconfoundingfactorsandiscalibratedtoalevellikelytodiscriminateperformancedifferencesofvariousproducts.Ininterpretingtheresults,itisthereforeimportantthatthefollowingdiscussionpointsaretakenintoaccount.
14.1. panel detection score (pds) and its relationship to sensitivity EvaluationoftheRDTsagainstthePhase2wild-typeparasitepanelwithparasitedensitiesof200parasites/µl(Figures8,9)revealedawiderangeoffrequencyandconsistencyofantigendetectionbetweenproducts,recordedasthe“PanelDetectionScore”(PDS).23Asexpected,testingathigherparasitedensities(2000[or5000]parasites/µl)resultsinsmallerdifferencesinperformance.Astwotestseachfromtwodifferentlotsweretestedat200parasites/µl,andasallfourresultshadtobepositiveforasampletobeconsidereddetectedbyanRDT,apositiveresultindicatedboththeabilityofaproducttodetectthetargetantigeninthesample,andtodothisconsistently(bothtestsfrombothlots).Parasitedensitiesofaround200parasites/µlshouldbedetectedtoensurehighfieldsensitivityforclinically-significantmalariainfectioninmanymalaria-endemicpopulations(5).
ThePDSagainstthepanelsusedinthisevaluationisexpectedtodifferfromthetestsensitivityinaspecificclinicalsettingforfivemainreasons.
i. Performancemayvarybetweenlotsorbatchesofthesameproduct.Variabilityinlotperformanceisanissuewithalldiagnostics,anditcannotbeguaranteedthattheresultsfoundherewillpredictresultsfromsubsequentRDTlots.Itisimportanttotestlotspriortodistributiontothe
22 Informationnoteoninterimselectioncriteriaforprocurementofmalariarapiddiagnostictests(RDTs)(January2010)http://new.paho.org/hq/dmdocuments/2010/infoRDTinterimcriteria.pdf(accessed25September,2011)
23 InthereportofWHOProductTesting:Round1thePDSwastermedthe‘DetectionRate’(3).
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)50
field,toensurethatexpectedperformanceismaintained(Section15.2).
ii. Inclinicalsettings,patientsshowawidevarietyofparasitedensities,therangeofwhichwilldependonthelocalepidemiologyofthedisease.Themagnitudeoftheparasitedensityinthepopulationtestedaffectstheclinicalsensitivityofthetest.PDSagainstthetestpanelofbloodsamplesdilutedto200parasites/µlarelikelytounderestimatetheclinicalsensitivityofanRDTinareasofhigh-transmissionwheresymptomaticpatientsoftenhavemuchhigherparasitedensitiesintheirblood.Manyteststhatshowedonlymoderatedetectionofthe200parasites/µlpanelmayperformwellinsuchsettings,asindicatedbythebetterPDSofmostprod-uctsagainstthepanelsetat2000parasites/µl. Importantly,wheninterpretingFiguresS1,S2,7-9,andthecolourcodinginTables3,4,thesmalldifferencesinpaneldetectionscoresfoundamongthebetter-performingRDTs in this evaluation areunlikely toresultinnoticeabledifferencesinclinicalsensitivity,andotherissuessuchasstability,cost,priorexperi-enceand trainingof the intendedusers, andeaseofuse(Annex5b)andmanufacturingcapacitymaybeequallyimportantfactorsintestselection. TakingintoconsiderationtheparasitedensityofthetargetpopulationsandthelikelyfieldsensitivityofRDTs,itisimportanttonotethat,eveninareaswithhightransmissionandstrongmalariaimmunity,populationsmayincludeindividualswithlowparasitedensitiesbutclinicallysignificantinfections(e.g.youngchildren,preg-nantwomen,thoseregularlyusingbednets,immigrants,andotherswithreducedimmunity).Theabilitytodetectlowparasitedensityinfectionsreliablythereforeremainsimportantinthesecases.Assomecountriesmovetowardselimination,populationimmunitywilldecreaseanditwillbecomeincreasinglyimportanttousediagnosticteststhatdetectlowparasitedensities(i.e.withhighPDSagainst200parasites/µlsamples).
iii. Performanceoftestsagainstthechallengepanelmaysometimesnotbepredictiveofsensitivityinclinicaltestingwhereantigenexpressionbycertainparasitepopulationsdiffersgreatlyfromthatinthepanel.Specifically,thereisevidencethatP. falciparumstrainsinsomeareasofSouthAmericadonotexpressHRP2antigensduetogenedeletions(18, 20). IfasignificantproportionofparasitesinagivenareadonotexpressHRP2,itisnecessarytousetestsdetectingothertargetantigens(eg.pLDHoraldolaseinthecaseofHRP2,3deletions).Thedistributionofsuchstrainsiscurrentlybeingmapped.Todate,nosignificantparasitepopulationswithhighfrequenciesofnon-expressionoftargetantigenshavebeenrecordedoutsideofSouthAmerica.
iv. TheconditionsunderwhichRDTsaretransportedandstoredcanaltertheirfieldsensitivity.Thetestsusedinthisevaluationwereshippedandstoredunderconditionsintendedtosafeguardagainstdegradationcausedbyhightemperatureorotherextremeconditions.IfsimilarprecautionsarenottakenwithpurchasedRDTs,lossofperformancecouldresult.Ambienttemperaturesofstorageconditionsvarywidelyinsettingswherethese
testsarecommonlyused,asdotemperaturesduringtransport,andrequirementsforheatstabilityofaproductwillthereforediffer.Testsshouldbetransportedandstoredwellwithinthetemperaturerangerecommendedbythemanufacturer,andextremesoftemperatureavoided.
v. Diagnosticsensitivityandspecificityaredependentonthequalityofpreparationandinterpretationofthetests.Highlytrainedindividualsperformedallthetestinginthisproductevaluation.Inclinicalsettings,malariaRDTswilloftenbeusedbyhealthworkerswithlimitedtrainingandsupervision.Simplicityofdesignandclearly-interpretableresultswillhaveaninfluenceonensuringthatthetech-nicalproficiencyofaproducttranslatesintoaccuratediagnosisinthefield.24
14.2. false-positive rate and specificity False-positiveratesarereportedhereagainstapanelofclean-negativesamplestakenfromblooddonatedinlow-transmissionsettingsbypeoplewithoutmalariasymptoms.Inaddition,false-positiverateswerecalculatedagainstasmallernumberofsampleswithspecificcharacteristicsthataffectthelikelihoodofafalse-positiveresultfromanimmuno-diagnostictest(e.g.rheumatoidfactor,anti-nuclearantibody),orthatmaybeofsignificanceinaspecificpopula-tioninmalaria-endemicareas(e.g.leishmaniasis,dengue).Theimportanceoftheseresultswillvarywiththeintendedareaofuse.Highfalse-positiveratesagainstsamplesofbloodfromdenguepatients,forexample,maynotbeasignificantfactortoconsiderinregionswheredenguedoesnotoccur.Inviewofthesmallnumberofsamplesineachcategoryinthisevaluation,theresultsshouldbeconsideredprimarilyasaguidetohighlightpotentialcross-reactionsthatwillrequireclosemonitoringifrelevanttothetargetpopulation.
Ingeneral,itispreferabletoprocureaproductwithalowrateoffalse-positivereactions.Inthecaseofmanydiagnostictests,atrade-offmustbemadebetweenapreferenceforahighrateofantigendetection(sensitivity)andalowfalse-positiverate(specificity).Thecontextinwhichthetestwillbeusedwillguidetherelativeimportanceofthesetwofactorsinchoosingoneproductoveranother.Overall,inthisevaluationtherewasnocorrelationoflowerPDS(lossofsensitivity)associatedwithlowfalse-positiverates(highspecificity).AnumberofproductsattainedbothahighPDSandalowfalse-positiverate.
14.3. Heat (thermal) stability RDTsinthisevaluationwereheldfortwomonthsat35°Cand45°Cand75%humidityandthenretestedtoevaluatestabilityatthesetemperatures.Theimportanceofthermalstabilitywillvaryaccordingtotheambientconditionsunderwhichaproductisexpectedtobetransportedandstored.Thus,stabilityathightemperatureswillbevitalifanRDTistobe
24Examplesavailablehere:http://www.wpro.who.int/sites/rdt/using_rdts/training/main.htm(accessed25September,2011);http://www.finddiagnostics.org/programs/malaria/find_activities/rdt-job-aids/(accessed25September,2011)
dis
cUss
ion
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 51
storedatcliniclevelinacountrywhereambienttemperaturescanreach45°Cinthehotseason,butlesscriticalinahigh-altitudeorcoolerenvironmentwheretemperaturesrarelyriseabove35°C.Manycommercially-availableRDTslist30°Casthemaximalstoragetemperature.Highertemperatureswereusedforthisevaluationbecauseitiscommonformalaria-endemiccountriestohavemaximumambienttemperaturesof35°Corabove,althoughtheuseofcoolstoragemethodscanallowstorageanduseofproductsdesignedforstoragebelowthesetemperatures.WheretransportandstorageofRDTsislikelytooccurathighambienttemperatures,heat(thermal)stabilityshouldbeseenasasignificantfactorinensuringmaintenanceofsensitivity.
HighhumiditywillacceleratethedegradationofmalariaRDTsandotherlateralflowtests.Alltheproductsinthisevaluationwerepackagedinindividualenvelopesthatcontainadesiccantandaredesignedtobemoisture-proof.Thisallowstheusertoopentheenvelopeofaspecifictestatthetimeofuse,limitingexposuretohighhumidity.Duringthestabilitytestingphaseofthisevaluation,RDTswerestoredat75%humidity.Thepackagingshould,ifingoodcondition,protectthecontentsfromexposuretohighhumidityduringstorage.Assuch,thestabilitytestingresultspresentedhereprovideanassessmentofboththestabilityoftheRDTandthequalityofitspackaging.
Severalproductsshowedhighstabilityatthetemperaturesandtimeperiodsusedinthisevaluation.Ingeneral,pan-specificlines(pLDH)performedlesswellatbaselineandwerelessstablethanHRP2testlines,buttherewasoverlapbetweenthestabilityoftestsagainstthesetargetswiththreepLDHtestlinesoncombinationtestsmaintainingverygoodpositivityratesonlowparasitedensities,aftertwomonthsat45°C.
Thoughtemperatureandhumiditywereheldconstantinthisevaluation,temperaturesinthefieldfluctuatewithtimeofdayandseason.Whiletwomonths’storageatasettemperaturecannotaccuratelypredictlong-termstabilityunderfieldconditions,lossofparasitedetectionoverthisperiodindicatesalikelihoodthatsignificantsensitivitywillbelostwhensimilarorhigherstoragetemperaturescompriseasignificantamountofthestoragetime,andindicateslikeli-hoodofahighersusceptibilitytodegradationduringshortperiodsofexposuretomuchhighertemperatures,suchasduringtransport(21, 22).
14.4. ease of use descriptionThesensitivityandspecificityofRDTresultsaredependentonthequalityofpreparationandinterpretationofthetest.Ingeneral,asimplerformatwithfewerstepsorfewerrequiredextraneousmaterialsislikelytobepreparedandinterpretedmorereliably.Thus,cassette-formatRDTsaregenerallymorereliablypreparedandinterpretedthanproductsindip-stickformat(23).Theextracostinvolvedinsuchaformatmaybeoffsetbytheadvantagesofincreasedaccuracyand,insomecases,lessadditionalequipmentrequiredtoperformthem.
Themethodofbloodtransferfromthepatienttothetestisimportantforthesafetyoftheuser,andfortheaccuracyof
volumeofbloodtransferred.DevicesforbloodtransferaresuppliedwithRDTs,andvarywidelyindesign.Theperform-anceofbloodtransferdeviceswasnotformallyassessedinthisevaluation,asbloodwastransferredfromatubebyamicro-pipettetoensurethemanufacturer-specifiedvolumewasused.ProgrammesprocuringRDTsshouldconsidertheadequacyofthebloodtransferdevicesupplied,includingpreviousexperienceofhealthworkersandthecostsandtimerequiredforre-training.Itmayoftenbeappropriatetodiscusswithmanufacturersthepossibilityofchangingthebloodtransferdevicefromthatnormallysupplied.
Clarityofresultsisimportanttotestinterpretation.Aclearlyvisible(intense)testlineislesslikelytobeoverlookedthanalinethatisbarelyvisible.Whilereadingproficiencyandadequateworkplacesshouldalwaysbeensured,healthworkersmaysometimeshavesub-optimalvisionorworkinconditionsofinadequatelighting.TheintensityofthelineofthetestbandiscloselyassociatedwiththePDSachievedbyRDTsinthisreport(TablesA4.2,A4.3).
Theimportanceofformatandsimplicityoftestdesignwilldependontheintendedend-users.Trainedlaboratorytechniciansmayhandleacomplicatedproceduremorereli-ablythanvillage-levelvolunteerswithlimitedsupervision.Inallcases,specificproficiency-basedtrainingandadequatesupervisionshouldbeincludedinanyRDT-baseddiagnosticprogramme,andclearinstructionsshouldbeprovidedinalanguageandformatappropriatefortheend-user(23-25).Annex5bprovidesguidanceonconductingafield-basedeaseofuseassessment.
14.5. inter-lot variability Thistestingprogrammeevaluatedonlytwoproductionlotsofeachproduct.MalariaRDTsarecomplexbiologicalproductsmadeofcomponentscommonlysuppliedfrommultiplesources,andsubjecttovariousconditionsduringmanufacturethatmayaffectthequalityofthefinalproduct.AllmanufacturersenteredinthisevaluationhavecurrentISO13485:2003certification,astandarddesignedtogiveassur-anceofconsistencyofqualityoffinalproduct,ifcorrectlyimplemented.Theresultspresentedhereindicatethatinter-lotvariabilitydoesoccur,andWHOstronglyrecommendsthatasampleofRDTsfromeachproductionlotbetestedpriortodisseminationtothefieldtoensureitmeetsanappropriatestandard.ThiscanbefacilitatedbyWHO(Section15.2).
Sinceinter-testvariabilityalsooccurs,thiswillbedetectedtosomeextentbyroutinelottesting.Ensuringmanufacturershavegoodmanufacturingstandardsshouldminimizethelikelihoodofinconsistenciesduetopoorpracticeinthemanu-facturingprocess.Culture-basedpanels25thataresubsetsofthePhase1panelofthisevaluationareavailableasreferencestandardsformanufacturerstosettheirownlot-releasecriteriaagainst,andthedevelopmentofpanelsbasedonrecombinantantigensisafocusofworkbyFIND,TDRandWHO.
25Toaccessthesepanels,[email protected],[email protected]@finddiagnostics.org.
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)52
14.6. target antigens and speciesMalariaRDTsincludedinthisevaluationdetectoneormoreofthreeparasiteantigens(HRP2,pLDH,andaldolase)invariouscombinations.HRP2ispresentonlyinP. falciparum,whereasaldolaseandpLDHarepresentinallfourspeciesandmaybeusedaspanorall-speciestargets.SometestsusedifferencesinpLDHsequencesbetweenspeciesasameanstodifferentiateP. falciparumfromP. vivaxandotherspecies.ThereisconsiderableoverlapinthePDSofproductstargetingthedifferentantigensinthisevaluation.WhiletheproductswiththehighestPDSforP. falciparumtargetedHRP2,anumberofpLDH-detectingproductsdemonstratedhighPDSagainstP. vivax.Thestabilityofteststargetingthesedifferentantigensalsooverlapped.
ThechoiceofRDTshouldtaketargetantigenintoaccount:HRP2-detectingRDTsshouldnotbeusedinareaswherehighratesofHRP2non-expressionoccur(18,20).TestsdetectingonlyHRP2(withoutpLDHoraldolaselines)willhavelimitedutilitywherenon-falciparummalariaiscommon.pLDH(andpossiblyaldolase)RDTsmayhavefurtheradvantageswhereantigenpersistence(commonwithHRP2)mayresultinahighfalse-positiverateinareaswhereearlyretestingintheweeksimmediatelyaftertreatmentiscommon.
Therequiredsensitivityofatestmayalsovarywithspecies;alesssensitivetestmaybeacceptablefordetectionofP. vivaxcomparedtodetectionofP. falciparum,assevereoutcomesduetomisseddiagnosesarelesslikely.Useofasufficientlysensitivepan-specifictestmaybeappropriateinareaswherebothP. falciparumandP. vivaxoccur,ifallinfectionsweretobemanagedinitiallyasaP. falciparuminfectionwithartemisinin-basedcombinationtherapy(ACT),butspecies-specificmonitoringdatawouldbelost.TestswithhighPDSforbothP. falciparumandP. vivaxweredemonstratedinthisandpreviousroundsofproducttesting(3, 4).
Itshouldbenotedthatpan-speciestestswerenotevaluatedfordetectionofP. ovaleorP. malariaeinthisevaluationduetolackofsourcesofsuitablemono-speciesinfectionsoftheseparasites.
15. Using tHese resUlts to ensUre QUalitY of diagnosis in tHe field
Thisreportprovidesdatatoguidemalariacontrolandmanagementprogrammesinselectingproductslikelytoperformtoahighstandardintheparticularcontextsinwhichtheprogrammeoperates.Thefinaldecisiononproductselectionrequiresthatthisdatabeconsideredinasystematicway,takingintocontextthedistributionofparasitedensitiesofthetargetpopulationamongwhomthetestswillbeused,andtheexperienceandtrainingoftheintendedusers.Furtherinformationshouldbesoughtfromthemanufacturerandothersources.AnalgorithmtoguidethisprocessisgiveninAnnex5a.26
WhilemalariaRDTscanbeappliedinanumberofsettings,thegreatestpotentialforimpactonpublichealthisinextensionofaccesstoaccurate,parasite-baseddiagnosisofmalariatoregionsandpopulationswheregoodqualitymicroscopy-basedanalysisisimpracticaltomaintain.ThismakespossibletheimplementationofrecentWHOrecommendationsonuniversalparasite-baseddiagnosispriortoanti-malarialtherapy(2).Thiscurrentlyappliestomostpeopleatriskofmalariainendemiccountries(1).InmanysettingswhereRDTshavebeenintroduced,thetruerateofparasitaemiahasbeenfoundtobeconsiderablylowerthanexpected,allowinghealthsystemstoreducewastageofanti-malarialmedicinesandtofocusontheappropriatemanagementofnon-malarialcausesoffever,includingearlypneumoniaandsepsis.AsuccessfulRDTprogrammemustthereforeaddressnotjustmalariabutalsothemanagementofothercommonandseverefebrileillnessesthatoccurlocally,inthedifferentialdiagnosesofmalaria,ifthepotentialfullpublichealthimpactofanRDTprogrammeistobeachieved.
15.1. beyond procurementDiagnostictestsnormallyrepresentthestartingpointinahealthsystemintervention,andtheirusepresumesthatappropriatepatientmanagement,basedontesting,willfollow.Thus,successfulintroductionofRDTsrequirescarefulplanningbeyondrationalprocurementtoensureconsistent
26Aninteractiveguidedesignedtohelpshort-listtestaccordingtoindividualprogrammeneeds,basedontheperformanceoftestsinrounds1,2and3oftheWHOProductTestingProgrammecanbefoundathttp://www.finddiagnostics.org/programs/malaria/find_activities/product_testing/
dis
cUss
ion
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 53
suppliesofallnecessarymaterials(includinggloves,sharpsdisposalcontainers,andsuppliesrequiredforfurthercasemanagement),trainingofend-users,communitysensitization,andmonitoringofdiagnosticqualityandresults.Thisextendsbeyondmalariamanagementtomanagementofotherfebrilediseasesandhealthservicedeliverysystems,andrequiresanintegratedapproachwithotherhealthprogrammesimpactingonthemanagementoffebrileillness.
ThisreportprovidesinformationtoguideprocurementofRDTswithinthisframework.Anumberoffactorsbeyondperformancecharacteristicsreportedheremustinfluenceprocurementdecisions.Anexamplealgorithm,includingeaseofuseassessment,isprovidedtoguidethesedecisionsinAnnexes5a,5b.
Details of implementation will vary widely betweenprogrammesaccordingtolocalcapacityandneeds.Furtherrecommendationsonbudgeting,planningandimplementationcanbefoundinAnnex6.
15.2. lot testingComplementarytotheproducttestingprogramme,WHO,TDRandFINDcurrentlysupportlaboratoriesthatperformcontinualqualityassuranceofRDTsintheformoflottesting.Thisprogrammerespondstorequestsfromnationalmalariaprogrammes,manufacturers,andprocurementbodiestoassessthequalityofRDTlotspriortopurchaseorwhentheyarriveincountry,priortodispersaltothefieldandclinicaluse.Testingisperformedagainstparasite-positiveandnegativepanelspreparedandcharacterizedinthesamewayasthepanelsusedinthisevaluation.Anumberofothernationalinstitutionshavealsodevelopedthiscapacity.Lot-testingreassurescountriesthattheproducttheyhavepurchasedisperformingtoahighstandardbeforedistribution,andhelpstoensurethatmanufacturersproduceconsistentlygoodlotsandimprovetheirproducts.
Countriesand/ormanufacturersshipbetween125-175RDTstotheregionallottestingcentreswheretheyareevaluatedagainstasmallpanelofparasitesathighandlowparasitedensitiesandnegativesamples(Figure2-IPC,RITM).Theyaresubsequentlyincubatedatatemperatureclosetothemanufacturer’sspecifiedstoragetemperatureandretestedatintervalsuntiltheirexpirydate.Initialresultsareavailableafterfivedaysandthensentatregularintervals.Detailsoftheprotocolcanbefoundinthepublishedmethodsmanualforlottesting (17).Nationalmalariaprogrammesandprocuringagenciesareencouragedtoparticipateinthelottestingprogramme.
ToaccesslottestingthroughtheWHO-FINDprogramme,contact:[email protected]@finddiagnostics.orgatleast2weeksbeforeRDTsarereadyforshipment.Furtherinformationisavailableatwww.wpro.who.int/sites/rdt/who_rdt_evalu-ation/lot_testing.htm,orthroughwww.finddiagnostics.org
16. conclUsions
ThisstudyaddstothelargedatasetonmalariaRDTperform-ancepublishedin2009and2010afterthefirstandsecondroundsofevaluations(3, 4).TheproducttestingprogrammeisalandmarkinthefieldofmalariaRDTevaluationsintermsofthenumberofproductsevaluatedanditscomprehensiveness.NewlaboratorymethodsweredevelopedandvalidatedtosupportparasitecharacterizationandthisworkgeneratednewfindingsregardingthevariationinantigencontentatsimilarparasitedensitiesandthevariationinthestructureandexpressionofHRPproteins.ThepublicationoftheWHOProductTestingRound1andRound2resultsimpactedontheprocurementpracticesofcountriesandprocurementagencies,andthisReportofRound3willaddconsiderablytothenumberofwell-performingRDTsforwhichcomprehensiveperformancedataisnowavailable,andprovidesupdateddataonproductsthathavebeenre-submittedfollowingproductmodification.
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)54
17. references
1. World Malaria Report 2010.Geneva,WorldHealthOrganization,2010.
2. Guidelines for the Treatment of Malaria, Second Edition.Geneva,WorldHealthOrganization,2010.
3. Malaria Rapid Diagnostic Test Performance : Results of WHO product testing of malaria RDTs: Round 1 (2008).Geneva,WorldHealthOrganization,2009.ISBN9789241598071
4. Malaria Rapid Diagnostic Test Performance : Results of WHO product testing of malaria RDTs: Round 2 (2009).Geneva,WorldHealthOrganization,2010.ISBN97892415994675.
5. Parasitological Confirmation of Malaria Diagnosis. Report of a WHO technical consultation Geneva, 6-8 October 2009. Geneva,WorldHealthOrganization,2010.ISBN9789241599412
6. Good practices for selecting and procuring rapid diagnostic tests for malaria.Geneva,WorldHealthOrganization,2011.ISBN9789241501125
7. Kolaczinski,J.,etal.,ComparisonoftheOptiMALrapidantigentestwithfieldmicroscopyforthedetectionofPlasmodium vivaxandP. falciparum:considerationsfortheapplicationoftherapidtestinAfghanistan. Ann Trop Med Parasitol,2004.98(1):p.15-20.
8. Richter,J.,etal.,Co-reactivityofplasmodialhistidine-richprotein2andaldolaseonacombinedimmuno-chromographic-malariadipstick(ICT)asapotentialsemi-quantitativemarkerofhighPlasmodium falciparumparasitaemia. Parasitol Res,2004.94(5):p.384-5.
9. Huong,N.M.,etal.,Comparisonofthreeantigendetectionmethodsfordiagnosisandtherapeuticmonitoringofmalaria:afieldstudyfromsouthernVietnam.Trop Med Int Health,2002.7(4):p.304-8.
10. Mason,D.P.,etal.,Acomparisonoftworapidfieldimmunochromatographicteststoexpertmicroscopyinthediagnosisofmalaria.Acta Trop,2002.82(1):p.51-9.
11. VandenBroek,I.,etal.,EvaluationofthreerapidtestsfordiagnosisofP. falciparumandP. vivaxmalariainColombia. Am J Trop Med Hyg,2006.75(6):p.1209-15.
12. McMorrow,M.L.,etal.,Challengesinroutineimplementationandqualitycontrolofrapiddiagnostictestsformalaria--RufijiDistrict,Tanzania.Am J Trop Med Hyg,2008.79(3):p.385-90.
13. Wanji,S.,etal.,PerformanceandusefulnessoftheHexagonrapiddiagnostictestinchildrenwithasymptomaticmalarialivingintheMountCameroonregion.Malar J,2008.7:p.89.
14. Willcox,M.L.,etal.,Rapiddiagnostictestsforthehome-basedmanagementofmalaria,inahigh-transmissionarea. Ann Trop Med Parasitol,2009.103(1):p.3-16.
15. Belizario,V.Y.,etal.,FieldevaluationofmalariarapiddiagnostictestsforthediagnosisofP. falciparumandnon-P. falciparuminfections.Southeast Asian J Trop Med Public Health,2005.36(3):p.552-61.
16 WHO-TDR-FIND-CDC.Methods manual for product testing of malaria rapid diagnostic tests (Version Three).Geneva,WorldHealthOrganization,2010.
17. WHO-TDR-FIND.Methods Manual for Laboratory Quality Control Testing of Malaria Rapid Diagnostic Tests, Version Six.Geneva,WorldHealthOrganization,2010.
18. BakerJ,HoMF,PelecanosA,GattonM,ChenN,AbdullahS,AlbertiniA,ArieyF,BarnwellJ,BellD,etal,Globalsequencevariationinthehistidine-richproteins2and3ofPlasmodium falciparum:implicationsfortheperformanceofmalariarapiddiagnostictests.MalarJ2010,9:129.
19. Methods for Field Trials of Malaria Rapid Diagnostic Tests.Manila, WorldHealthOrganizationRegionalOfficefortheWesternPacific,2009.
20. 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.
21. Jorgensen,P.,etal.,Malariarapiddiagnostictestsintropicalclimates:Theneedforacoolchain.American Journal of Tropical Medicine and Hygiene,2006.74(5).
22. Chiodini,P.L.,etal.,TheheatstabilityofPlasmodiumlactatedehydrogenase-basedandhistidine-richprotein2-basedmalariarapiddiagnostictests. Trans R Soc Trop Med Hyg,2007.101(4):p.331-7.
23. Rennie,W.,etal.,Minimisinghumanerrorinmalariarapiddiagnosis:clarityofwritteninstructionsandhealthworkerperformance.Trans R Soc Trop Med Hyg,2007.101(1):p.9-18.
24. Harvey,S.A.,etal.,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):p.160.
25. Tavrow,P.,EKnebel,LCogswell,Using quality design to improve malaria rapid diagnostic tests in Malawi, in Operations Research Results 1(4). 2000,PublishedfortheUnitedStatesAgencyforInternationalDevelopment(USAID)bytheQualityAssuranceProject(QAP):Bethesda,Maryland.
26. ThiamS,ThiorM,FayeB,NdiopM,DioufML,DioufMB,DialloI,FallFB,NdiayeJL,AlbertiniA,etal:Majorreductioninanti-malarialdrugconsumptioninsenegalafternation-wideintroductionofmalariarapiddiagnostictests.PLoSOne2011,6:e18419
ann
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anneXes
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)56
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 57
Plas
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3030
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s in
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tte
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card
(B);
cass
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rid (C
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pstic
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prod
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houl
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mpa
nied
by
all r
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C T1 T2C
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sam
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and
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T1C T2
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)58
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 59
annex 2: Malaria rdt guide to results interpretation
type a: Malaria generic pf rdt results guideResults Window:C=controlline;T=testlinewithboundHRP-2orPf-specificpLDHantibody.
C T
Negative Results:Oneline‘C’appearsintheresultswindow.
C T
Positive Results:P. falciparuminfection.Twolines‘C’and‘T’appearintheresultswindow.Testispositiveevenifthetestlineisfaint.
C T
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T
C T
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)60
type b: Malaria generic Major plasmodium species (pan) rdt results guide Results Window:C=controlline;T=testlinewithboundpan-specificpLDHoraldolaseantibody.
C T
Negative Results:Oneline‘C’appearsintheresultswindow.
C T
Positive Results: Plasmodiumspecies(P. falciparum, P. vivax, P.malariae, P.ovale)infection.Twolines‘C’and‘T’appearintheresultswindow.Testispositiveevenisthetestlineisfaint.
C T
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T
C T
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 61
type c: Malaria generic pan-pf rdt results guideResults Window:C=controlline;T1=testlinewithboundpLDHoraldolaseantibody;T2=testlinewithboundHRP2
and/orPfspecificpLDHantibody.
C T2T1
Negative Results:Onlyoneline‘C’appearsintheresultswindow.
C T1 T2
Positive Results:
P. falciparum:Twolines‘C’and‘T2”appearintheresultswindow.
C T1 T2
Non-falciparum infection(P. vivax, P.ovale, P.malariae)ormixedinfectionofthese:Twolines‘C’and‘T1”appearintheresultswindow.
C T1 T2
P. falciparumormixedinfection.Threelines‘C’,‘T1’and‘T2’appearintheresultswindow.
C T1 T2
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)62
type d: Malaria generic pf-pan rdt results guideResults Window:C=controlline;T1=testlinewithboundHRP2orPfspecificLDHantibody;
T2=testlinewithboundpLDHoraldolaseantibody.
C T2T1
Negative Results:Onlyoneline‘C’appearsintheresultswindow.
C T1 T2
Positive Results:
P. falciparum infection.Twolines‘C’and‘T1’appearintheresultswindow.
C T1 T2
Non-falciparum infection(P. vivax, P.ovale, P.malariae)ormixedinfectionofthese.Twolines‘C’and‘T2’appearintheresultswindow.
C T1 T2
P. falciparumormixedinfection.Threelines‘C’,‘T1’and‘T2’appearintheresultswindow.
C T1 T2
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 63
type e: Malaria generic pv-pf rdt results guideResults Window:C=controlline;T1=testlinewithboundP. vivaxspecificpLDH;
T2=testlinewithboundHRP2orPf-specificpLDHantibody.
C T2T1
Negative Results:Onlyoneline‘C’appearsintheresultswindow.
C T1 T2
Positive Results:
P. falciparuminfection.Twolines‘C’and‘T2’appearintheresultswindow.
C T1 T2
P. vivaxinfection.Twolines‘C’and‘T1’appearintheresultswindow.
C T1 T2
P. falciparum and P. vivax mixedinfection.Threelines‘C’,‘T1’and‘T2’appearintheresultswindow.
C T1 T2
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)64
type f: Malaria generic pf-pv rdt results guideResults Window:C=controlline;T1=testlinewithboundHRP2orPf-specificpLDHantibody;
T2=testlinewithboundP. vivaxspecificpLDH.
C T2T1
Negative Results:Onlyoneline‘C’appearsintheresultswindow.
C T1 T2
Positive Results:
P. falciparuminfection.Twolines‘C’and‘T1’appearintheresultswindow.
C T1 T2
P. vivaxinfection.Twolines‘C’and‘T2’appearintheresultswindow.
C T1 T2
P. falciparum and P. vivax mixedinfection.Threelines‘C’,‘T1’and‘T2’appearintheresultswindow.
C T1 T2
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 65
type g: Malaria generic pan-pv-pf rdt results guideResults Window:C=controlline;T1=testlineboundwithpLDHoraldolaseantibody;T2=testlinewithboundP. vivaxspecific
pLDH;T3=testlinewithboundHRP2orPf-specificpLDHantibody
C T2 T3T1
Negative Results:Onlyoneline‘C’appearsintheresultswindow.
C T1 T2 T3
Positive Results:
P. falciparuminfection.Twolines‘C’and‘T3’appearintheresultswindow.
C T1 T2 T3
P. vivaxinfection.Twolines‘C’and‘T2’appearintheresultswindow.
C T1 T2 T3
P. falciparum withorwithoutmixedinfectionwithP. ovaleorP. malariae.Threelines‘C’,‘T1’and‘T3’appearintheresultswindow.
C T1 T2 T3
P. falciparum andP. vivaxmixedinfection.Threelines‘C’,‘T2’and‘T3’appearintheresultswindow.
C T1 T2 T3
P. falciparum andP. vivaxmixedinfectionwithorwithoutP. ovaleand/orP. malariaeinfection.Fourlines‘C’,‘T1’,‘T2’and‘T3’appearintheresultswindow.
C T1 T2 T3
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)66
P. vivaxwithorwithoutP. ovaleand/orP. malariaeinfection.Threelines‘C’,‘T1’and‘T2’appearintheresultswindow.
C T1 T2 T3
P. malariaeand/orP. ovaleP. vivaxinfection.Twolines‘C’and‘T1’appearintheresultswindow.
C T1 T2 T3
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
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
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 67
type H: Malaria generic VoM1-pf rdt results guideResults Window:C=controlline;T1=testlineboundwithpLDHspecificfornon.P. falciparum(P. vivax, P. ovaleandP. malariae);
T2=testlinewithboundHRP2orPf-specificpLDHantibody
C T2T1
Negative Results:Onlyoneline‘C’appearsintheresultswindow.
C T1 T2
Positive Results:
P. falciparuminfection.Twolines‘C’and‘T2’appearintheresultswindow.
C T1 T2
P. falciparummixedinfection(withanyoneormoreofP. vivax, P. ovaleandP. malariae).Threelines‘C’,‘T1’and‘T2’appearintheresultswindow.
C T1 T2
Non-P. falciparum infection(P. vivax, P. ovaleandP. malariae)ormixedinfectionofthese.Twolines‘C’and‘T1’appearintheresultswindow.
C T1 T2
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
1 VOM-P. vivax, P. ovale, P. malariae
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)68
type i: Malaria generic pv rdt results guide Results Window:C=controlline;T=testlineboundwithP. vivaxspecificpLDH.
C T
Negative Results:Onlyoneline‘C’appearsintheresultswindow.
C T
Positive Results: P. vivaxinfection.Twolines‘C’and‘T’appearintheresultswindow.
C T
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T
C T
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 69
type j: Malaria generic pf-pf rdt results guideResults Window:C=controlline;T1=testlineboundwithpLDHspecificforP. falciparum;
T2=testlineboundwithHRP2.
C T2T1
Negative Results:Onlyoneline‘C’appearsintheresultswindow.
C T1 T2
Positive Results:
P. falciparuminfection.Twolines‘C’and‘T1’appearintheresultswindow.
C T1 T2
P. falciparum infection.Twolines‘C’and‘T2’appearintheresultswindow.
C T1 T2
P. falciparum infection.Threelines‘C’,‘T1’and‘T2’appearintheresultswindow.
C T1 T2
Invalid Results:No‘C’lineappearsintheresultswindow.RepeatthetestusinganewRDTifnocontrollineappears.
C T1 T2
C T1 T2
C T1 T2
C T1 T2
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)70
anne
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.020
.017
.017
.020
.019
.0 (1
9)IM
MU
NOQ
UIC
K CO
NTA
CT M
ALAR
IA +
4 05
25K2
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osyn
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.016
.0 (1
9)16
.0 (1
9)17
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alar
ia P
an T
est
MAL
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01Di
ma
• G
esel
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aft f
ür D
iagn
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a m
bH15
.019
.015
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.014
.014
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alar
ia p
f (H
RP II
) / (P
AN-p
LDH
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igen
Det
ectio
n Te
st D
evic
e M
FV-1
24R
AZOG
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.20
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alar
ia p
f (pL
DH) /
PAN
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est D
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e
MFV
-124
AZOG
, Inc
.1.
01.
00.
01.
00.
00.
018
.019
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alas
can™
Dev
ice
- Ra
pid
test
for M
alar
ia P
f/Pa
n 50
4020
25Ze
phyr
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tem
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8)17
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00.
00.
00.
00.
00.
019
.017
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e St
ep M
alar
ia P
.f/Pa
n Te
st
W56
-CG
uang
zhou
Won
dfo
Biot
ech
Co. L
td.
8.0
9.0
6.0
11.0
(19)
11.0
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19.0
(19)
20.0
OnSi
te P
f/Pa
n M
alar
ia A
g Ra
pid
Test
R0
113C
CTK
Biot
ech,
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19.0
18.0
20.0
20.0
20.0
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ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 71
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
P. f
alci
paru
m s
ampl
es (n
=20)
Tota
l pos
itive
res
ults
ret
urne
d
200
para
sites
/µl
2000
par
asite
s/µl
Lot
1Lo
t 2
Lot
1Lo
t 2
Test
1Te
st 2
No.
pos
itive
ag
reem
ents
b (m
ax=2
0)Te
st 1
Test
2N
o. p
ositi
ve
agre
emen
tsb
(max
=20)
Test
1Te
st 2
OptiM
AL-I
T 71
0024
Diam
ed -
A D
ivis
ion
of B
io-R
ad15
.015
.013
.012
.013
.09.
020
.020
.0Pa
rasc
reen
™ D
evic
e -
Rapi
d te
st fo
r Mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
al S
yste
ms
20.0
20.0
20.0
20.0
20.0
20.0
20.0
20.0
SD B
IOLI
NE
Mal
aria
Ag
P.f/
Pan
05FK
60St
anda
rd D
iagn
ostic
s In
c.20
.020
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BIO
LIN
E M
alar
ia A
g 05
FK40
Stan
dard
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gnos
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1.0
0.0
1.0
1.0
0.0
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20.0
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step
™ E
asy
Mal
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Pan
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st D
evic
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angz
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.019
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and
Pv
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lity™
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Ste
p M
alar
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v Tr
i-Li
ne T
est
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Tec
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ucts
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.020
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.0Ad
vant
age
Mal
aria
Car
d IR
2110
25J.
Mitr
a &
Co.
Pvt
. Ltd
.18
.018
.017
.019
.017
.017
.020
.020
.0BI
ONOT
E M
ALAR
IA P
.f.&
P.v.
Ag
Rapi
d Te
st K
it RG
19-1
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e,In
c.20
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.0 (1
9)18
.0 (1
9)19
.020
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re™
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aria
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PfM
AL-1
9002
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re D
iagn
ostic
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.0 (1
9)19
.0 (1
9)20
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alar
ia p
f (H
RP II
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v (p
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igen
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st D
evic
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FV-1
24V
AZOG
, Inc
.20
.019
.019
.019
.019
.018
.020
.020
.0On
Site
Mal
aria
Pf/
Pv A
g Ra
pid
Test
R0
112C
CTK
Biot
ech,
Inc.
20.0
20.0
20.0
17.0
19.0
16.0
20.0
20.0
Pf, P
an a
nd P
vCo
re™
Mal
aria
Pan
/Pv/
Pf
MAL
-190
026
Core
Dia
gnos
tics
20.0
20.0
20.0
20.0
20.0
20.0
19.0
20.0
diag
nost
icks
MAL
ARIA
(Pan
/Pv/
Pf) C
asse
tte
MPN
VFC1
007.
5SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s19
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.0 (1
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n on
lyCl
earv
iew
® M
alar
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LDH
70
8840
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geni
cs Lt
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nver
ness
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19.0
18.0
19.0
19.0
19.0
20.0
20.0
diag
nost
icks
MAL
ARIA
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) Cas
sett
e M
PNW
BC10
07.3
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
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9.0
4.0
2.0
5.0
2.0
20.0
20.0
Para
bank
™ D
evic
e -
Rapi
d te
st fo
r Mal
aria
Pan
50
3010
25Ze
phyr
Bio
med
ical
Sys
tem
s8.
05.
03.
06.
06.
04.
020
.020
.0
Pf: P
lasm
odiu
m fa
lcip
arum
Pv
: Pla
smod
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
rs 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.
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)72
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
(20
0) a
nd h
igh
(200
0) p
aras
ite
dens
ities
(pa
rasi
tes/
µl)
Prod
uct
Cata
logu
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mbe
rM
anuf
actu
rer
200
para
sites
/µl
2000
par
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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
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nced
Qua
lity™
One
Ste
p M
alar
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.f Te
stIT
P110
02TC
40In
Tec
Prod
ucts
, Inc
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313
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.811
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00.
00.
010
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/AN
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E M
ALAR
IA P
.f. A
g Ra
pid
Test
Kit
RG19
-11
Bion
ote,
Inc.
7.5
10.0
51.3
22.5
8.8
0.0
0.0
2.5
12.5
85.0
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Clea
rvie
w®
Mal
aria
P.f.
VB
01Vi
sion
Bio
tech
(Pty
) Ltd
3.8
15.0
42.5
30.0
8.8
0.0
0.0
2.5
12.5
85.0
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Core
™ M
alar
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f M
AL-1
9002
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re D
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03.
827
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00.
010
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T Di
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stic
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alar
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020
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00.
02.
510
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NTA
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00.
00.
07.
527
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anoS
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g RM
AF10
Biol
and,
Ltd
10.0
12.5
63.8
11.3
2.5
5.0
2.5
7.5
27.5
57.5
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
One
Step
Mal
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Tes
t (ca
sset
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5223
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ross
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Beiji
ng) C
o., L
td.
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33.8
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
One
Step
Mal
aria
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Test
W
37-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
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30.
02.
57.
532
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Site
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pid
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114C
CTK
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ech,
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8.8
65.0
22.5
0.0
0.0
0.0
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42.5
47.5
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Para
chec
k® P
f Dev
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alci
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3030
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N/A
N/A
N/A
N/A
N/A
N/A
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Para
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apid
test
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alar
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012
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Para
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f (De
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IC10
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7.5
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57.5
22.5
2.5
0.0
0.0
7.5
15.0
77.5
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Para
HIT
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00.
015
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LIN
E M
alar
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f. (H
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93.8
13.8
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26.3
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0.0
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20.0
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62.5
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17.5
92.5
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Pf a
nd P
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alar
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an/P
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apid
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00.
012
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0.0
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0.0
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OTE
MAL
ARIA
P.f.
& P
an A
g Ra
pid
Test
Kit
RG19
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ote,
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1.3
10.0
25.0
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0.0
0.0
0.0
12.5
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0.0
0.0
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w®
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bo
VB11
Visi
on B
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ty) L
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tech
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M
PNFW
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nost
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0.0
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00.
00.
00.
00.
067
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50.
00.
0
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aria
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0.0
0.0
0.0
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85.0
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0.0
0.0
92.5
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0.0
0.0
0.0
45.0
55.0
0.0
0.0
0.0
Mal
asca
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evic
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st fo
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1.3
6.3
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37.5
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0.0
0.0
2.5
5.0
92.5
70.0
30.0
0.0
0.0
0.0
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alar
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anoS
ign
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0.0
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00.
010
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0.0
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One
Step
Mal
aria
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Test
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05.
015
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ann
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s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 73
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
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rer
200
para
sites
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Perc
enta
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Pf
te
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and
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Perc
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Pf
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Perc
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Perc
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and
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0a1
23
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OptiM
AL-I
T 71
0024
Diam
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A D
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io-R
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80.
00.
00.
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80.
00.
00.
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™ D
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97.5
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22.5
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0.0
0.0
0.0
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82.5
10.0
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012
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LIN
E M
alar
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g 05
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dard
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97.5
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0.0
0.0
0.0
0.0
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0.0
0.0
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™ E
asy
Mal
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Pf/
Pan
Rapi
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evic
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and
Pv
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia P
.f/P.v
Tri-L
ine
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IT
P110
03 T
C40
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oduc
ts, I
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0.0
27.5
53.8
17.5
1.3
0.0
0.0
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40.0
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Adva
ntag
e M
alar
ia C
ard
IR21
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J. M
itra
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o. P
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0.0
0.0
7.5
27.5
65.0
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
BION
OTE
MAL
ARIA
P.f.
& P
.v. A
g Ra
pid
Test
Kit
RG19
-12
Bion
ote,
Inc.
3.8
6.3
28.8
46.3
15.0
0.0
0.0
0.0
15.0
85.0
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Core
™ M
alar
ia P
v/Pf
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-190
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gnos
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0.0
0.0
31.3
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0.0
0.0
12.5
87.5
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Mal
aria
pf (
HRP
II) /
pv
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H) A
ntig
en D
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tion
Test
Dev
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MFV
-124
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3.8
26.3
33.8
30.0
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0.0
0.0
5.0
12.5
82.5
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
OnSi
te M
alar
ia P
f/Pv
Ag
Rapi
d Te
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R011
2CCT
K Bi
otec
h, In
c.5.
011
.362
.517
.53.
80.
00.
05.
037
.557
.5N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/APf
, Pan
and
Pv
Core
™ M
alar
ia P
an/P
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M
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re D
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s0.
00.
036
.343
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.02.
50.
00.
010
.087
.510
0.0
0.0
0.0
0.0
0.0
17.5
35.0
47.5
0.0
0.0
diag
nost
icks
MAL
ARIA
(Pan
/Pv/
Pf) C
asse
tte
MPN
VFC1
007.
5SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s1.
33.
822
.536
.336
.30.
00.
00.
07.
592
.597
.52.
50.
00.
00.
05.
050
.045
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00.
0Pa
n on
ly
Clea
rvie
w®
Mal
aria
pLD
H
7088
4025
Orge
nics
Ltd
. (In
vern
ess
Med
ical
In
nova
tions
)N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A6.
356
.337
.50.
00.
00.
00.
00.
057
.542
.5
diag
nost
icks
MAL
ARIA
(Pan
) Cas
sett
e M
PNW
BC10
07.3
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
73.8
23.8
2.5
0.0
0.0
0.0
20.0
65.0
15.0
0.0
Para
bank
™ D
evic
e -
Rapi
d te
st fo
r Mal
aria
Pan
50
3010
25Ze
phyr
Bio
med
ical
Sys
tem
sN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A68
.827
.53.
80.
00.
00.
05.
067
.527
.50.
0
Pf: P
lasm
odiu
m fa
lcip
arum
Pv
: Pla
smod
ium
viv
ax
pan:
Pla
smod
ium
spec
ies
N/A
: not
app
licab
lea
Deno
tes
no b
and
visi
ble
b Ca
lcul
atio
ns in
clud
e in
valid
test
sc
Resu
lts fo
r pf-
HRP
2 lin
e/pf
-pLD
H li
ne, r
espe
ctiv
ely
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)74
anne
x 4:
pha
se 2
res
ults
Tabl
eA4.
1: L
ot v
aria
bilit
y 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
(20
0) a
nd h
igh
(200
0) p
aras
ite
dens
ity
(par
asit
es/µ
l)
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
P. f
alci
paru
m s
ampl
es (n
=99)
P. v
ivax
sam
ples
(n=3
5)To
tal p
ositi
ve r
esul
tsa
retu
rned
Tota
l pos
itive
res
ults
a re
turn
ed
200
para
sites
/µl
2000
b pa
rasit
es/µ
l20
0 pa
rasit
es/µ
l20
00b
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=9
9)Te
st 1
Test
2N
o. p
ositi
ve
agre
emen
tsc
(max
=99)
Test
1Te
st 2
Test
1Te
st 2
No.
pos
itive
ag
reem
ents
c (m
ax=4
0)Te
st 1
Test
2N
o. p
ositi
ve
agre
emen
tsc
(max
=40)
Test
1Te
st 2
Pf o
nly
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia P
.f Te
stIT
P110
02TC
40In
Tec
Prod
ucts
, Inc
.94
.097
.094
.098
.096
.095
.099
.099
.0N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
BION
OTE
MAL
ARIA
P.f.
Ag
Rapi
d Te
st K
it RG
19-1
1Bi
onot
e,In
c.93
.093
.091
.086
.0.0
(9
8)86
.084
.0 (9
8)99
.098
.0N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Clea
rvie
w®
Mal
aria
P.f.
VB
01Vi
sion
Bio
tech
(Pty
) Ltd
90.0
87.0
84.0
91.0
90.0
87.0
99.0
99.0
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Core
™ M
alar
ia P
f M
AL-1
9002
0Co
re D
iagn
ostic
s97
.097
.096
.096
.0 (9
8)97
.096
.0 (9
8)99
.099
.0N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AIC
T Di
agno
stic
s M
alar
ia P
.f.
ML0
1IC
T Di
agno
stic
s89
.088
.086
.092
.092
.092
.097
.099
.0N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AIM
MU
NOQ
UIC
K CO
NTA
CT fa
lcip
arum
05
19K2
5Bi
osyn
ex85
.086
.083
.087
.084
.0 (9
8)83
.0 (9
8)99
.099
.0N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
anoS
ign
Mal
aria
Pf A
g RM
AF10
Biol
and,
Ltd
92.0
90.0
88.0
91.0
(98)
91.0
87.0
(98)
98.0
(98)
98.0
(98)
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
One
Step
Mal
aria
P.F
Tes
t (ca
sset
te)
5223
52Bl
ue C
ross
Bio
-Med
ical
(B
eijin
g) C
o., L
td.
86.0
81.0
(98)
78.0
(98)
80.0
78.0
73.0
96.0
97.0
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
One
Step
Mal
aria
P.f
Test
W
37-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.75
.076
.070
.072
.072
.065
.097
.0 (9
8)98
.0N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
OnSi
te P
f Ag
Rapi
d Te
st
R011
4CCT
K Bi
otec
h, In
c.89
.094
.088
.096
.092
.090
.099
.099
.0N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/APa
rach
eck®
Pf D
evic
e- R
apid
test
for
P. fa
lcip
arum
Mal
aria
Ver
. 3
3030
1025
Orch
id B
iom
edic
al S
yste
ms
97.0
95.0
(98)
95.0
(98)
96.0
(98)
96.0
95.0
(98)
95.0
(95)
98.0
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Para
chec
k® P
f Dip
stic
k- R
apid
test
for
P. fa
lcip
arum
Mal
aria
Ver
. 3
3030
2025
Orch
id B
iom
edic
al S
yste
ms
94.0
91.0
89.0
93.0
95.0
92.0
98.0
98.0
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Para
HIT
® -
f (De
vice
) 55
IC10
2-50
Span
Dia
gnos
tics
Ltd.
87.0
88.0
85.0
93.0
89.0
89.0
99.0
99.0
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Para
HIT
® -f
(Dip
stic
k)
55IC
101-
50Sp
an D
iagn
ostic
s Lt
d.86
.085
.083
.088
.087
.083
.099
.098
.0N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/ASD
BIO
LIN
E M
alar
ia A
g P.
f. (H
RP2/
pLDH
)05
FK90
Stan
dard
Dia
gnos
tics
Inc.
97.0
96.0
96.0
93.0
90.0
88.0
99.0
99.0
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Pf a
nd P
an
ABON
Mal
aria
Pan
/P.f.
Rap
id T
est D
evic
e IM
A-B4
02AB
ON B
ioph
arm
(Han
gzho
u)
Co. L
td.
79.0
78.0
75.0
79.0
77.0
74.0
99.0
98.0
0.0
0.0
0.0
0.0
0.0
0.0
24.0
27.0
BION
OTE
MAL
ARIA
P.f.
& P
an A
g Ra
pid
Test
Kit
RG19
-08
Bion
ote,
Inc.
97.0
95.0
95.0
95.0
95.0
94.0
99.0
98.0
34.0
32.0
32.0
33.0
33.0
32.0
35.0
35.0
Care
Star
t™ M
alar
ia/P
regn
ancy
Com
bo
(pLD
H/H
RP2/
HCG
) G
O221
Acce
ss B
io, I
NC.
95.0
95.0
94.0
87.0
87.0
83.0
99.0
98.0
(98)
35.0
35.0
35.0
35.0
32.0
(34)
32.0
(34)
34.0
35.0
Care
Star
t™ M
alar
ia p
LDH
3 L
ine
Test
G
O121
Acce
ss B
io, I
NC.
96.0
96.0
96.0
91.0
91.0
88.0
99.0
99.0
35.0
35.0
35.0
34.0
33.0
32.0
35.0
35.0
Care
Star
t™ M
alar
ia S
cree
n G
O231
Acce
ss B
io, I
NC.
96.0
94.0
93.0
90.0
91.0
86.0
99.0
99.0
34.0
34.0
33.0
35.0
33.0
33.0
35.0
35.0
Clea
rvie
w®
Mal
aria
Com
bo
VB11
Visi
on B
iote
ch (P
ty) L
td85
.086
.084
.093
.090
.087
.099
.099
.010
.09.
04.
011
.011
.06.
032
.034
.0Cl
earv
iew
® M
alar
ia D
ual T
est D
evic
e VB
20Vi
sion
Bio
tech
(Pty
) Ltd
86.0
80.0
78.0
81.0
80.0
74.0
98.0
97.0
27.0
(34)
30.0
25.0
(34)
28.0
28.0
22.0
34.0
34.0
diag
nost
icks
MAL
ARIA
(Pan
/Pf)
Cass
ette
M
PNFW
BC10
07.4
SSA
Diag
nost
ics
& B
iote
ch
Syst
ems
99.0
98.0
98.0
97.0
(98)
97.0
(98)
96.0
(97)
99.0
99.0
31.0
28.0
26.0
29.0
26.0
23.0
34.0
(34)
34.0
ICT
Diag
nost
ics
Mal
aria
Com
bo
ML0
2IC
T Di
agno
stic
s90
.090
.087
.093
.092
.090
.098
.098
.015
.014
.09.
09.
012
.06.
033
.033
.0IC
T Di
agno
stic
s M
alar
ia D
ual
ML0
3IC
T Di
agno
stic
s81
.085
.079
.087
.0 (9
8)87
.0 (9
8)85
.0 (9
7)98
.098
.0 (9
8)28
.030
.025
.033
.033
.031
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.0IM
MU
NOQ
UIC
K CO
NTA
CT M
ALAR
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4 05
25K2
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.078
.077
.079
.0 (9
8)82
.077
.0 (9
8)98
.098
.011
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.0 (3
3)8.
0 (3
3)15
.013
.010
.033
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Mal
aria
Pan
Tes
t M
AL-
W23
N-0
01Di
ma
• G
esel
lsch
aft f
ür
Diag
nost
ika
mbH
84.0
82.0
77.0
68.0
66.0
56.0
99.0
96.0
6.0
2.0
1.0
8.0
6.0
1.0
30.0
20.0
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 75
Prod
uct
Cata
logu
e nu
mbe
rM
anuf
actu
rer
P. f
alci
paru
m s
ampl
es (n
=99)
P. v
ivax
sam
ples
(n=3
5)To
tal p
ositi
ve r
esul
tsa
retu
rned
Tota
l pos
itive
res
ults
a re
turn
ed
200
para
sites
/µl
2000
b pa
rasit
es/µ
l20
0 pa
rasit
es/µ
l20
00b
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=9
9)Te
st 1
Test
2N
o. p
ositi
ve
agre
emen
tsc
(max
=99)
Test
1Te
st 2
Test
1Te
st 2
No.
pos
itive
ag
reem
ents
c (m
ax=4
0)Te
st 1
Test
2N
o. p
ositi
ve
agre
emen
tsc
(max
=40)
Test
1Te
st 2
Mal
aria
pf (
HRP
II) /
(PAN
-pLD
H) A
ntig
en
Dete
ctio
n Te
st D
evic
e M
FV-1
24R
AZOG
, Inc
.97
.095
.0 (9
8)95
.0 (9
8)98
.096
.096
.099
.099
.01.
00.
00.
01.
01.
00.
034
.034
.0
Mal
aria
pf (
pLDH
) / P
AN-p
LDH
Tes
t Dev
ice
M
FV-1
24AZ
OG, I
nc.
8.0
(98)
10.0
4.0
(98)
7.0
9.0
(98)
5.0
(98)
77.0
78.0
11.0
14.0
9.0
7.0
6.0
(34)
4.0
(34)
35.0
34.0
Mal
asca
n™ D
evic
e -
Rapi
d te
st fo
r Mal
aria
Pf
/Pan
50
4020
25Ze
phyr
Bio
med
ical
Sys
tem
s96
.093
.0 (9
8)92
.0 (9
8)86
.0 (9
7)91
.0 (9
8)82
.0 (9
6)95
.0 (9
5)95
.0 (9
8)30
.0 (3
4)33
.0 (3
4)29
.0 (3
3)24
.0 (3
3)24
.019
.0 (3
3)34
.0 (3
4)34
.0 (3
4)
Nan
oSig
n M
alar
ia P
f/Pa
n Ag
RM
AP10
Biol
and,
Ltd
87.0
88.0
82.0
88.0
90.0
84.0
99.0
99.0
4.0
3.0
2.0
1.0
1.0
1.0
34.0
33.0
Nan
oSig
n M
alar
ia P
f/Pv
Ag
-RM
AD10
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and,
Ltd
13.0
14.0
9.0
9.0
12.0
7.0
92.0
91.0
7.0
7.0
(34)
6.0
(34)
4.0
6.0
3.0
35.0
35.0
One
Step
Mal
aria
P.f/
Pan
Test
W
56-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.49
.0 (9
6)45
.0 (9
5)39
.0 (9
3)58
.0 (9
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.0 (9
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.0 (9
3)91
.0 (9
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.0 (9
8)32
.0 (3
4)32
.0 (3
4)31
.0 (3
4)31
.0 (3
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.0 (3
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te P
f/Pa
n M
alar
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g Ra
pid
Test
R0
113C
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90.0
92.0
89.0
88.0
91.0
85.0
99.0
99.0
32.0
32.0
30.0
34.0
34.0
33.0
35.0
35.0
OptiM
AL-I
T 71
0024
Diam
ed -
A D
ivis
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io-R
ad68
.067
.058
.061
.063
.058
.096
.097
.035
.035
.035
.034
.035
.034
.024
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.0 (3
4)Pa
rasc
reen
™ De
vice
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test
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alar
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an/P
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3100
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phyr
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med
ical
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tem
s99
.098
.098
.092
.093
.0 (9
7)88
.0 (9
7)99
.096
.026
.027
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.022
.033
.032
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BIO
LIN
E M
alar
ia A
g P.
f/Pa
n 05
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Stan
dard
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gnos
tics
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96.0
96.0
95.0
94.0
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95.0
(98)
92.0
(97)
99.0
98.0
35.0
35.0
35.0
34.0
35.0
34.0
35.0
35.0
SD B
IOLI
NE
Mal
aria
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05FK
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anda
rd D
iagn
ostic
s In
c.25
.027
.020
.031
.030
.023
.097
.094
.035
.035
.035
.035
.034
.034
.035
.035
.0Su
rest
ep™
Eas
y M
alar
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f/Pan
Rap
id Te
st D
evic
e IM
A-T4
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ON B
iote
ch (H
angz
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87.0
90.0
87.0
89.0
91.0
87.0
99.0
99.0
3.0
2.0
1.0
2.0
35.0
35.0
Pf a
nd P
vAd
vanc
ed Q
ualit
y™ O
ne S
tep
Mal
aria
P.f/
P.v
Tri-
Line
Tes
t IT
P110
03
TC40
InTe
c Pr
oduc
ts, I
nc.
92.0
(98)
92.0
88.0
(98)
96.0
93.0
92.0
99.0
99.0
2.0
0.0
0.0
2.0
1.0
0.0
5.0
3.0
Adva
ntag
e M
alar
ia C
ard
IR21
1025
J. M
itra
& C
o. P
vt. L
td.
89.0
86.0
86.0
82.0
81.0
78.0
98.0
99.0
29.0
27.0
25.0
17.0
12.0
11.0
35.0
35.0
BION
OTE
MAL
ARIA
P.f.
& P
.v. A
g Ra
pid
Test
Kit
RG19
-12
Bion
ote,
Inc.
95.0
96.0
94.0
95.0
94.0
93.0
99.0
97.0
35.0
35.0
35.0
34.0
35.0
34.0
35.0
35.0
Core
™ M
alar
ia P
v/Pf
MAL
-190
022
Core
Dia
gnos
tics
98.0
99.0
98.0
97.0
98.0
97.0
99.0
99.0
32.0
33.0
32.0
27.0
25.0
21.0
35.0
34.0
Mal
aria
pf (
HRP
II) /
pv
(pLD
H) A
ntig
en
Dete
ctio
n Te
st D
evic
e M
FV-1
24V
AZOG
, Inc
.92
.092
.088
.084
.082
.080
.099
.099
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00.
00.
00.
00.
00.
013
.016
.0
OnSi
te M
alar
ia P
f/Pv
Ag
Rapi
d Te
st
R011
2CCT
K Bi
otec
h, In
c.91
.089
.086
.092
.088
.087
.099
.099
.035
.035
.035
.035
.034
.034
.035
.035
.0Pf
, Pan
and
Pv
Core
™ M
alar
ia P
an/P
v/Pf
M
AL-1
9002
6Co
re D
iagn
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s96
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8)93
.0 (9
7)92
.0 (9
6)96
.0 (9
8)95
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8)93
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7)98
.0 (9
8)98
.010
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07.
09.
0 (3
4)7.
0 (3
3)6.
0 (3
2)34
.034
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agno
stic
ks M
ALAR
IA (P
an/P
v/Pf
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sett
eM
PNVF
C100
7.5
SSA
Diag
nost
ics &
Bio
tech
Sys
tem
s94
.0 (9
6)96
.0 (9
7)92
.0 (9
4)97
.0 (9
8)94
.0 (9
8)92
.0 (9
7)97
.0 (9
7)98
.012
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09.
0 (3
4)8.
06.
0 (3
4)34
.0 (3
4)33
.0Pa
n on
ly
Clea
rvie
w®
Mal
aria
pLD
H
7088
4025
Orge
nics
Ltd
. (In
vern
ess
Med
ical
Inno
vatio
ns)
90.0
87.0
87.0
89.0
(98)
88.0
82.0
(98)
98.0
98.0
(98)
32.0
30.0
(34)
29.0
(34)
34.0
35.0
34.0
35.0
34.0
(34)
diag
nost
icks
MAL
ARIA
(Pan
) Cas
sett
e M
PNW
BC10
07.3
SSA
Diag
nost
ics
& B
iote
ch
Syst
ems
34.0
34.0
28.0
25.0
(98)
25.0
18.0
(98)
92.0
(98)
95.0
30.0
27.0
(34)
23.0
(34)
26.0
23.0
22.0
35.0
35.0
Para
bank
™ D
evic
e -
Rapi
d te
st fo
r Mal
aria
Pan
50
3010
25Ze
phyr
Bio
med
ical
Sys
tem
s34
.0 (9
8)31
.023
.0 (9
8)31
.034
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.096
.090
.0 (9
8)28
.026
.024
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.028
.027
.035
.035
.0
Pf: P
lasm
odiu
m fa
lcip
arum
Pv
: Pla
smod
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
rs in
stru
ctio
ns.
b 8
(8%
) of t
he 9
9 P.
falc
ipar
um d
ilutio
n sa
mpl
es s
ets
wer
e 20
0 an
d 50
00 p
aras
ites/
µl a
nd 2
(6%
) of t
he 3
5 P.
viv
ax d
ilutio
n sa
mpl
e se
ts w
ere
200
and
5000
par
asite
s/µl
c
Num
ber o
f sam
ples
that
retu
rned
a p
ositi
ve re
sult
for b
oth
test
s. W
here
one
test
was
inva
lid a
nd th
e ot
her p
ositi
ve, p
ositi
ve a
gree
men
t was
reco
rded
.
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)76
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
(20
0) a
nd h
igh
(200
0) p
aras
ite
dens
ities
(pa
rasi
tes/
µl)
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
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
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia
P.f T
est
ITP1
1002
TC40
InTe
c Pr
oduc
ts, I
nc.
2.8
12.6
53.0
20.2
11.4
0.0
1.0
6.6
14.7
77.8
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
BION
OTE
MAL
ARIA
P.f.
Ag
Rapi
d Te
st K
it RG
19-1
1Bi
onot
e,In
c.9.
614
.426
.319
.730
.10.
50.
02.
59.
187
.9N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
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/AN
/AN
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/ACl
earv
iew
® M
alar
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.f.
VB01
Visi
on B
iote
ch (P
ty) L
td9.
612
.125
.313
.139
.90.
01.
53.
53.
591
.4N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/ACo
re™
Mal
aria
Pf
MAL
-190
020
Core
Dia
gnos
tics
2.3
6.8
15.4
22.2
53.3
0.0
0.0
1.0
3.5
95.5
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
ICT
Diag
nost
ics
Mal
aria
P.f.
M
L01
ICT
Diag
nost
ics
8.8
13.6
24.2
15.9
37.4
1.0
0.0
2.0
6.1
90.9
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
IMM
UN
OQU
ICK
CON
TACT
falc
ipar
um
0519
K25
Bios
ynex
13.4
25.8
28.0
22.5
10.4
0.0
2.0
4.6
15.2
78.3
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Nan
oSig
n M
alar
ia P
f Ag
RMAF
10Bi
olan
d, L
td8.
114
.129
.817
.230
.81.
00.
03.
06.
189
.9N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
One
Step
Mal
aria
P.F
Tes
t (ca
sset
te)
5223
52Bl
ue C
ross
Bio
-Med
ical
(B
eijin
g) C
o., L
td.
17.9
18.2
30.8
13.9
19.2
2.5
1.0
4.6
11.6
80.3
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
One
Step
Mal
aria
P.f
Test
W
37-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.25
.521
.029
.315
.98.
31.
52.
511
.616
.268
.2N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
OnSi
te P
f Ag
Rapi
d Te
st
R011
4CCT
K Bi
otec
h, In
c.6.
315
.928
.534
.314
.90.
00.
05.
114
.180
.8N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/APa
rach
eck®
Pf D
evic
e- R
apid
test
for
P. fa
lcip
arum
Mal
aria
Ver
. 3
3030
1025
Orch
id B
iom
edic
al
Syst
ems
2.5
3.5
14.4
26.3
53.3
0.5
0.0
0.0
4.0
95.5
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Para
chec
k® P
f Dip
stic
k- R
apid
test
fo
r P. f
alci
paru
m M
alar
ia V
er. 3
30
3020
25Or
chid
Bio
med
ical
Sy
stem
s5.
812
.625
.329
.626
.81.
00.
51.
57.
689
.4N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Para
HIT
® -
f (De
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Span
Dia
gnos
tics
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9.9
17.9
25.0
23.2
24.0
0.0
1.5
2.5
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84.9
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Para
HIT
® -f
(Dip
stic
k)
55IC
101-
50Sp
an D
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d.12
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51.
05.
116
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/ASD
BIO
LIN
E M
alar
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g P.
f. (H
RP2/
pLDH
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0 /2
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0 /1
0.6
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Pf a
nd P
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ON M
alar
ia P
an/P
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apid
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52.
05.
611
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50.
00.
040
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63.
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BION
OTE
MAL
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P.f.
& P
an A
g Ra
pid
Test
Kit
RG19
-08
Bion
ote,
Inc.
3.5
6.3
15.2
26.5
48.5
0.5
0.0
0.5
4.0
95.0
69.2
25.8
4.0
0.8
0.3
4.0
12.6
31.3
36.4
15.7
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Care
Star
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alar
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mbo
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8.1
13.1
29.3
22.2
27.3
0.0
0.0
3.5
8.6
87.9
9.6
25.8
35.9
21.5
7.3
0.5
0.0
4.6
26.8
68.2
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Care
Star
t™ M
alar
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LDH
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Test
G
O121
Acce
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5.6
10.6
27.3
23.2
33.3
0.0
0.0
1.0
7.1
91.9
8.6
23.5
37.1
22.2
8.6
0.0
0.0
4.0
24.8
71.2
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Care
Star
t™ M
alar
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cree
n G
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Acce
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6.3
9.1
26.0
26.3
32.3
0.0
0.5
4.6
4.6
90.4
9.1
22.7
33.1
23.7
11.4
0.0
0.5
4.6
23.2
71.7
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Clea
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w®
Mal
aria
Com
bo
VB11
Visi
on B
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ty) L
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02.
04.
06.
687
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80.
05.
116
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iew
® M
alar
ia D
ual T
est D
evic
e VB
20Vi
sion
Bio
tech
(Pty
) Ltd
17.4
10.4
22.2
18.2
31.8
1.5
2.0
2.0
6.6
87.9
78.3
17.2
3.5
1.0
0.0
9.6
16.2
34.3
27.3
12.6
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
diag
nost
icks
MAL
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(Pan
/Pf)
Cass
ette
M
PNFW
BC10
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Diag
nost
ics
&
Biot
ech
Syst
ems
0.8
5.6
21.0
24.8
48.0
0.0
0.0
1.0
4.0
95.0
74.2
18.9
5.1
1.5
0.3
6.1
14.1
37.4
25.3
17.2
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
ICT
Diag
nost
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Mal
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Com
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agno
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00.
03.
57.
188
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00.
03.
013
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T Di
agno
stic
s M
alar
ia D
ual
ML0
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T Di
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00.
53.
54.
090
.971
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.27.
10.
50.
55.
614
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02.
04.
018
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51.
00.
05.
624
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Mal
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t M
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31.
51.
014
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00.
025
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60.
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Mal
aria
pf (
HRP
II) /
(PAN
-pLD
H)
Antig
en D
etec
tion
Test
Dev
ice
MFV
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RAZ
OG, I
nc.
2.5
9.1
22.7
24.2
41.4
0.0
0.0
2.5
5.1
92.4
99.0
0.3
0.8
0.0
0.0
41.9
30.8
25.3
1.5
0.5
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 77
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
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para
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and
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Perc
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Perc
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pa
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and
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Perc
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pa
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and
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)
Perc
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ban
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Perc
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test
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0a1
23
40a
12
34
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23
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12
34
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23
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34
Mal
aria
pf (
pLDH
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AN-p
LDH
Tes
t De
vice
M
FV-1
24AZ
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nc.
91.4
7.6
1.0
0.0
0.0
21.7
28.3
39.4
9.6
1.0
98.7
1.0
0.3
0.0
0.0
54.0
25.8
19.2
1.0
0.0
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Mal
asca
n™ D
evic
e -
Rapi
d te
st fo
r M
alar
ia P
f/Pa
n 50
4020
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phyr
Bio
med
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50.
01.
02.
593
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51.
05.
14.
032
.825
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.8N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
Nan
oSig
n M
alar
ia P
f/Pa
n Ag
RM
AP10
Biol
and,
Ltd
10.9
12.6
31.6
14.4
30.6
0.0
0.5
4.0
8.6
86.9
98.7
1.0
0.3
0.0
0.0
57.6
24.2
17.7
0.0
0.5
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Nan
oSig
n M
alar
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f/Pv
Ag
-RM
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and,
Ltd
87.9
10.1
1.3
0.8
0.0
7.6
22.2
41.9
17.7
10.6
99.2
0.8
0.0
0.0
0.0
95.5
4.6
0.0
0.0
0.0
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
One
Step
Mal
aria
P.f/
Pan
Test
W
56-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.47
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.016
.27.
87.
16.
66.
111
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.170
.226
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50.
50.
312
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/AN
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/AN
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OnSi
te P
f/Pa
n M
alar
ia A
g Ra
pid
Test
R0
113C
CTK
Biot
ech,
Inc.
8.8
11.9
30.6
31.1
17.7
0.0
0.0
5.1
16.2
78.8
50.5
35.9
12.4
1.3
0.0
2.0
11.6
41.4
34.3
10.6
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
OptiM
AL-I
T 71
0024
Diam
ed -
A D
ivis
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of
Bio-
Rad
34.6
37.1
26.3
1.3
0.8
2.5
3.5
24.8
25.3
43.9
35.1
38.4
24.5
1.3
0.8
2.0
3.0
27.3
25.8
41.9
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Para
scre
en™
Dev
ice
- Ra
pid
test
for
Mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
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al
Syst
ems
3.5
2.3
20.7
15.9
57.6
1.5
0.0
0.0
1.5
97.0
69.4
20.7
8.3
0.8
0.8
7.1
12.6
37.4
23.2
19.7
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
SD B
IOLI
NE
Mal
aria
Ag
P.f/
Pan
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iagn
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50.
00.
53.
096
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80.
53.
53.
022
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/ASD
BIO
LIN
E M
alar
ia A
g 05
FK40
Stan
dard
Dia
gnos
tics I
nc.
71.5
20.2
4.0
1.5
2.8
3.5
11.6
30.3
32.3
22.2
76.0
17.9
4.8
1.3
0.0
3.5
13.1
34.9
32.8
15.7
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Sure
step
™ E
asy
Mal
aria
Pf/
Pan
Rapi
d Te
st D
evic
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A-T4
02AC
ON B
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ch
(Han
gzho
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o. L
td.
9.9
12.4
35.4
22.7
19.7
0.0
0.0
5.6
12.6
81.8
100.
00.
00.
00.
00.
082
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00.
00.
0N
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Pf a
nd P
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vanc
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ualit
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ne S
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Mal
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P.
f/P.
v Tr
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819
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01.
58.
614
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50.
50.
083
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00.
0
Adva
ntag
e M
alar
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ard
IR21
1025
J. M
itra
& C
o. P
vt. L
td.
14.7
11.6
27.3
19.4
27.0
0.5
1.0
4.6
7.1
86.9
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
99.5
0.5
0.0
0.0
0.0
99.5
0.0
0.5
0.0
0.0
BION
OTE
MAL
ARIA
P.f.
& P
.v. A
g Ra
pid
Test
Kit
RG19
-12
Bion
ote,
Inc.
4.0
7.1
18.2
26.8
43.9
1.0
0.0
0.5
3.5
95.0
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
99.8
0.3
0.0
0.0
0.0
97.0
0.5
2.0
0.5
0.0
Core
™ M
alar
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v/Pf
MAL
-190
022
Core
Dia
gnos
tics
1.0
5.3
12.6
24.2
56.8
0.0
0.0
0.0
3.0
97.0
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
99.8
0.3
0.0
0.0
0.0
100.
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00.
00.
00.
0M
alar
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f (H
RP II
) / p
v (p
LDH
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tigen
Det
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FV-1
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01.
05.
17.
686
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/AN
/AN
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0.0
0.0
0.0
0.0
0.0
100.
00.
00.
00.
00.
0
OnSi
te M
alar
ia P
f/Pv
Ag
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st
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K Bi
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113
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05.
115
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/AN
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alar
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515
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03.
596
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31.
524
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610
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0.0
0.0
0.0
0.0
99.5
0.5
0.0
0.0
0.0
diag
nost
icks
MAL
ARIA
(Pan
/Pv/
Pf)
Cass
ette
MPN
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007.
5SS
A Di
agno
stic
s &
Bi
otec
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610
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0.0
0.0
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0.0
Pan
only
Clea
rvie
w®
Mal
aria
pLD
H
7088
4025
Orge
nics
Ltd
. (In
vern
ess
Med
ical
Inno
vatio
ns)
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
10.6
23.2
36.4
21.2
8.6
0.5
0.0
2.0
13.6
83.8
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
diag
nost
icks
MAL
ARIA
(Pan
) Cas
sett
e M
PNW
BC10
07.3
SSA
Diag
nost
ics
&
Biot
ech
Syst
ems
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
70.2
18.9
9.6
0.5
0.8
5.6
8.1
33.8
24.8
27.8
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Para
bank
™ D
evic
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Calc
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inva
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sults
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RP2
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line
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pect
ivel
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)78
Tabl
e A
4.3:
Dis
trib
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n of
Pan
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test
ban
d in
tens
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5040
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 79
Prod
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)80
Tabl
eA4.
4: P
anel
det
ectio
n sc
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of P
hase
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 81
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
200
para
sites
/µl
2000
b pa
rasit
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lPa
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ntin
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l det
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Afric
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2)As
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0)So
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7)Af
rica
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Asia
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Sout
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SD B
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Afric
a -
Uni
ted
Repu
blic
of T
anza
nia,
Cen
tral
Afr
ican
Rep
ublic
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agas
car,
Nig
eria
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ya, E
thio
pia
Asia
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yanm
ar, T
he P
hilip
pine
s, Ca
mbo
dia
Sout
h Am
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Peru
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ombi
aPf
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smod
ium
falc
ipar
um
Pv: P
lasm
odiu
m v
ivax
pa
n: P
lasm
odiu
m sp
ecie
sa
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 te
chni
cian
, at m
inim
um s
peci
fied
read
ing
time,
are
pos
itive
b 8
(8%
) of t
he 9
9 P.
falc
ipar
um d
ilutio
n sa
mpl
es s
ets
wer
e 20
0 an
d 50
00 p
aras
ites/
µl
c PD
S pr
esen
ted
in th
e ta
ble
is b
ased
on
a po
sitiv
e pf
test
line
(eith
er p
f-H
RP2
or p
f-pL
DH).
P. fa
lcip
arum
PDS
bas
ed o
n in
divi
dual
test
line
s w
as :
pf-p
LDH
( 25
.8, 5
, 0%
at 2
00p/
µl (A
fric
a/As
ia/S
.Am
eric
a); 9
6.8,
95,
100%
at 2
000p
/µl (
Afric
a/As
ia/S
. Am
eric
a) a
nd p
f-H
RP2
(85.
5, 9
0,
94.1
% a
t 200
p/µl
(Afr
ica/
Asia
/S.A
mer
ica)
; 100
, 100
, 100
% a
t 200
0p/µ
l (Af
rica/
Asia
/S.A
mer
ica)
)
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)82
Tabl
e A
4.5:
P. f
alci
paru
m t
est
line
fals
e po
siti
ve r
ates
for
Pha
se 2
P. v
ivax
sam
ples
at
low
(20
0) a
nd h
igh
(200
0) p
aras
ite
dens
ities
(pa
rasi
tes/
µl)
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
P. v
ivax
sam
ples
(n=3
5)
200
para
sites
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2000
a pa
rasit
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lFa
lse
posi
tive
Pf in
fect
ionb
(%
)Fa
lse
posi
tive
Pf in
fect
ionb
(%
)
Lot
1 (n
=70)
Lot
2 (n
=70)
Ove
rall
(n=1
40)
Lot
1 (n
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Lot
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Ove
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0)Pf
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ne S
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Test
ITP1
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34.3
35.7
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ntig
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etec
tion
Test
Dev
ice
MFV
-124
RAZ
OG, I
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7.9
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0.0
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AN-p
LDH
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t Dev
ice
M
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0.0
0.0
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0.0
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00.
00.
0M
alas
can™
Dev
ice
- Ra
pid
test
for M
alar
ia P
f/Pa
n 50
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phyr
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tem
s0.
0 (6
8)1.
5 (6
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7 (1
36)
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Nan
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n M
alar
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f/Pa
n Ag
RM
AP10
Biol
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Nan
oSig
n M
alar
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f/Pv
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0.0
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e St
ep M
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0 (6
8)On
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st
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00.
00.
0Op
tiMAL
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amed
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31.4
8.8
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20.3
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Para
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test
for M
alar
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91.
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BIO
LIN
E M
alar
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g P.
f/Pa
n 05
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dard
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0.0
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0.0
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ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 83
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
P. v
ivax
sam
ples
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5)
200
para
sites
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2000
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rasit
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posi
tive
Pf in
fect
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(%
)Fa
lse
posi
tive
Pf in
fect
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(%
)
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1 (n
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Lot
2 (n
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Ove
rall
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0)SD
BIO
LIN
E M
alar
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g 05
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0.0
0.0
0.0
0.0
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™ E
asy
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Pan
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st D
evic
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ch (H
angz
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00.
00.
00.
00.
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and
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lity™
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Ste
p M
alar
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i-Li
ne T
est
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ucts
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98.
65.
75.
72.
94.
3Ad
vant
age
Mal
aria
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2110
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Mitr
a &
Co.
Pvt
. Ltd
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01.
40.
70.
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00.
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E M
ALAR
IA P
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re D
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alar
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v (p
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igen
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41.
41.
40.
00.
00.
0On
Site
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aria
Pf/
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g Ra
pid
Test
R0
112C
CTK
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ech,
Inc.
0.0
0.0
0.0
0.0
0.0
0.0
Pf, P
an a
nd P
vCo
re™
Mal
aria
Pan
/Pv/
Pf
MAL
-190
026
Core
Dia
gnos
tics
0.0
0.0
(67)
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01.
4di
agno
stic
ks M
ALAR
IA (P
an/P
v/Pf
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sett
eM
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Diag
nost
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ch S
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ms
0.0
0.0
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0.0
(139
)2.
9 (3
4)2.
92.
9 (6
9)Pa
n on
ly
Clea
rvie
w®
Mal
aria
pLD
H
7088
4025
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nics
Ltd
. (In
vern
ess
Med
ical
In
nova
tions
)N
/AN
/AN
/AN
/AN
/AN
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diag
nost
icks
MAL
ARIA
(Pan
) Cas
sett
e M
PNW
BC10
07.3
SSA
Diag
nost
ics
& B
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ch S
yste
ms
N/A
N/A
N/A
N/A
N/A
N/A
Para
bank
™ D
evic
e -
Rapi
d te
st fo
r Mal
aria
Pan
50
3010
25Ze
phyr
Bio
med
ical
Sys
tem
sN
/AN
/AN
/AN
/AN
/AN
/A
Pf: P
lasm
odiu
m fa
lcip
arum
Pv
: Pla
smod
ium
viv
ax
pan:
Pla
smod
ium
spec
ies
a 2
(6%
) of t
he 3
5 P.
viv
ax d
ilutio
n sa
mpl
e se
ts w
ere
200
and
5000
par
asite
s/µl
b Pf
line
pos
itive
indi
cate
s a
fals
e po
sitiv
e P.
falc
ipar
um in
fect
ion
c Bo
th p
f-H
RP2
and
pf-p
LDH
test
line
s in
divi
dual
ly re
turn
ed 0
% fa
lse
posi
tive
rate
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)84
Tabl
e A
4.6:
Pan
(or
Pv)
tes
t lin
e fa
lse
posi
tive
rat
e fo
r no
n-Pf
infe
ctio
n on
Pha
se 2
P. f
alci
paru
m s
ampl
es a
t lo
w (
200)
and
hig
h (2
000)
par
asit
e de
nsiti
es (
para
site
s/µl
)
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
P. f
alci
paru
m s
ampl
es (n
=99)
200
para
sites
/µl
2000
a pa
rasit
es/µ
lFa
lse p
ositi
ve n
on-P
f in
fect
ion
(%)
False
pos
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non
-Pf
infe
ctio
n (%
)
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1 (n
=198
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t 2
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98)
Ove
rall
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96)
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1 (n
=99)
Lot
2 (n
=99)
Ove
rall
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98)
Pf o
nly
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia P
.f Te
stIT
P110
02TC
40In
Tec
Prod
ucts
, Inc
.N
/AN
/AN
/AN
/AN
/AN
/ABI
ONOT
E M
ALAR
IA P
.f. A
g Ra
pid
Test
Kit
RG19
-11
Bion
ote,
Inc.
N/A
N/A
N/A
N/A
N/A
N/A
Clea
rvie
w®
Mal
aria
P.f.
VB
01Vi
sion
Bio
tech
(Pty
) Ltd
N/A
N/A
N/A
N/A
N/A
N/A
Core
™ M
alar
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f M
AL-1
9002
0Co
re D
iagn
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/AN
/AN
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T Di
agno
stic
s M
alar
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ML0
1IC
T Di
agno
stic
sN
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MU
NOQ
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NTA
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lcip
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/AN
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anoS
ign
Mal
aria
Pf A
g RM
AF10
Biol
and,
Ltd
N/A
N/A
N/A
N/A
N/A
N/A
One
Step
Mal
aria
P.F
Tes
t (ca
sset
te)
5223
52Bl
ue C
ross
Bio
-Med
ical
(Bei
jing)
Co.
, Ltd
.N
/AN
/AN
/AN
/AN
/AN
/AOn
e St
ep M
alar
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.f Te
st
W37
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uang
zhou
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dfo
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ech
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td.
N/A
N/A
N/A
N/A
N/A
N/A
OnSi
te P
f Ag
Rapi
d Te
st
R011
4CCT
K Bi
otec
h, In
c.N
/AN
/AN
/AN
/AN
/AN
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rach
eck®
Pf D
evic
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apid
test
for P
. fal
cipa
rum
Mal
aria
Ver
. 3
3030
1025
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id B
iom
edic
al S
yste
ms
N/A
N/A
N/A
N/A
N/A
N/A
Para
chec
k® P
f Dip
stic
k- R
apid
test
for P
. fal
cipa
rum
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aria
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. 3
3030
2025
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id B
iom
edic
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yste
ms
N/A
N/A
N/A
N/A
N/A
N/A
Para
HIT
® -
f (De
vice
) 55
IC10
2-50
Span
Dia
gnos
tics
Ltd.
N/A
N/A
N/A
N/A
N/A
N/A
Para
HIT
® -f
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stic
k)
55IC
101-
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an D
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s Lt
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LIN
E M
alar
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g P.
f. (H
RP2/
pLDH
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FK90
Stan
dard
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gnos
tics
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N/A
N/A
N/A
N/A
N/A
N/A
Pf a
nd P
anAB
ON M
alar
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an/P
.f. R
apid
Tes
t Dev
ice
IMA-
B402
ABON
Bio
phar
m (H
angz
hou)
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Ltd
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00.
00.
00.
00.
00.
0BI
ONOT
E M
ALAR
IA P
.f.&
Pan
Ag
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it RG
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00.
00.
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ombo
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O221
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ss B
io, I
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4.0
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0.0
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reSt
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Mal
aria
pLD
H 3
Lin
e Te
st
GO1
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00.
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51.
80.
00.
00.
0Cl
earv
iew
® M
alar
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ombo
VB
11Vi
sion
Bio
tech
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0.0
0.0
0.0
0.0
0.0
0.5
Clea
rvie
w®
Mal
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Dua
l Tes
t Dev
ice
VB20
Visi
on B
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ch (P
ty) L
td0.
00.
00.
00.
00.
00.
0di
agno
stic
ks M
ALAR
IA (P
an/P
f) Ca
sset
te
MPN
FWBC
1007
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A Di
agno
stic
s &
Bio
tech
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tem
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00.
0 (1
96)
0.0
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00.
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T Di
agno
stic
s M
alar
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M
L02
ICT
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nost
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0.0
0.0
0.0
0.0
0.0
ICT
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nost
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Mal
aria
Dua
l M
L03
ICT
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nost
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1.0
0.0
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)0.
5 (3
94)
0.0
0.0
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0.0
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MU
NOQ
UIC
K CO
NTA
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ALAR
IA +
4 05
25K2
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53.
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97)
1.8
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01.
00.
0M
alar
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est
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N-0
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ma
• G
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lsch
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ür D
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bH2.
03.
52.
80.
01.
00.
0M
alar
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f (H
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) / (P
AN-p
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igen
Det
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n Te
st D
evic
e M
FV-1
24R
AZOG
, Inc
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0 (1
97)
0.0
0.0
(395
)0.
00.
08.
1M
alar
ia p
f (pL
DH) /
PAN
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est D
evic
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MFV
-124
AZOG
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0 (1
97)
0.0
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0 (3
94)
0.0
0.0
0.0
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
0.5
(197
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5 (1
95)
1.0
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5)0.
0 (9
8)1.
0 (1
93)
Nan
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n M
alar
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f/Pa
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AP10
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0.0
0.0
0.0
0.0
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oSig
n M
alar
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f/Pv
Ag
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AD10
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and,
Ltd
0.5
0.5
0.5
0.0
0.0
0.0
One
Step
Mal
aria
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Pan
Test
W
56-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
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2 (1
91)
11.5
(192
)8.
4 (3
83)
0.0
(95)
2.0
(98)
0.0
(193
)On
Site
Pf/
Pan
Mal
aria
Ag
Rapi
d Te
st
R011
3CCT
K Bi
otec
h, In
c.0.
02.
51.
30.
00.
00.
0Op
tiMAL
-IT
7100
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amed
- A
Div
isio
n of
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-Rad
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1.0
1.0
0.5
Para
scre
en™
Dev
ice
- Ra
pid
test
for M
alar
ia P
an/P
f50
3100
25Ze
phyr
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med
ical
Sys
tem
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02.
0 (1
96)
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)0.
01.
00.
0SD
BIO
LIN
E M
alar
ia A
g P.
f/Pa
n 05
FK60
Stan
dard
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gnos
tics
Inc.
0.0
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5 (3
94)
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0.0
0.5
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 85
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
P. f
alci
paru
m s
ampl
es (n
=99)
200
para
sites
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rasit
es/µ
lFa
lse p
ositi
ve n
on-P
f in
fect
ion
(%)
False
pos
itive
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infe
ctio
n (%
)
Lot
1 (n
=198
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t 2
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98)
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rall
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1 (n
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SD B
IOLI
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05FK
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00.
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rest
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y M
alar
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f/Pa
n Ra
pid
Test
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tech
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o. L
td.
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Pf a
nd P
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vanc
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& P
.v. A
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Kit
RG19
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alar
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v/Pf
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pv
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MFV
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te M
alar
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smod
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smod
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he 9
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falc
ipar
um d
ilutio
n sa
mpl
es s
ets
wer
e 20
0 an
d 50
00 p
aras
ites/
µl
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)86
Tabl
e A
4.7:
Pha
se 2
fal
se p
ositi
ve r
ate
for
P. f
alci
paru
m t
est
line
resu
lts
on a
ll m
alar
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egat
ive
sam
ples
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uct
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logu
e
num
ber
Man
ufac
ture
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Perc
enta
ge o
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lse p
ositi
ve P
f te
st li
nes
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lean
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gativ
e sa
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esPe
rcen
tage
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es c
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inin
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ium
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ectio
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gent
sb
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enta
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 87
Prod
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Cata
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num
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Resu
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)88
Tabl
e A
4.8:
Pha
se 2
fal
se p
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ve r
ate
for
P. f
alci
paru
m in
sam
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gens
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 89
Prod
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Cata
logu
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num
ber
Man
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Perc
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f fa
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)90
Tabl
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4.9:
Pha
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fal
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 91
Prod
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Man
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Perc
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112C
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87.5
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50
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phyr
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)92
Tabl
e A
4.10
: Pha
se 2
fal
se p
ositi
ve r
ate
of p
an t
est
line
resu
lts
on a
ll m
alar
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sam
ples
Prod
uct
Cata
logu
e
num
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Man
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ture
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Perc
enta
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f fa
lse p
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ve p
an
test
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Test
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TC40
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N/A
N/A
N/A
N/A
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on B
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-190
020
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
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Diag
nost
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M
L01
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
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TACT
falc
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Nan
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n M
alar
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f Ag
RMAF
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e St
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est (
cass
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2352
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
One
Step
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Test
W
37-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
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Site
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g Ra
pid
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R0
114C
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
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Para
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Para
HIT
® -
f (De
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Span
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
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N/A
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Pf a
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ON M
alar
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apid
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angz
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00.
00.
00.
00.
00.
00.
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ALAR
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evic
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tech
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0.0
1.0
0.5
0.0
0.0
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M
PNFW
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Mal
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pf (
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0 (9
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6.9
6.9
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n™ D
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5040
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0.0
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6 (5
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Nan
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alar
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One
Step
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Pan
Test
W
56-C
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ondf
o Bi
otec
h Co
. Ltd
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1 (9
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1 (9
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1 (1
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11.9
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00.
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0
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 93
Prod
uct
Cata
logu
e
num
ber
Man
ufac
ture
r
Perc
enta
ge o
f fa
lse p
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an
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line
s on
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ana
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ples
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f fa
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ve p
an
test
line
s on
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ples
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no
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pid
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T402
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0.0
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0.0
0.0
0.0
0.0
0.0
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0 (9
9)0.
0 (1
99)
0.0
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0.0
0.0
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0.0
0.0
0.0
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only
Clea
rvie
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7088
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023
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0 (4
1)2.
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2 (8
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8 (5
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MAL
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sett
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PNW
BC10
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SSA
Diag
nost
ics
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ms
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Para
bank
™ D
evic
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Rapi
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st fo
r Mal
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01.
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50.
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00.
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0
Pf: P
lasm
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smod
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smod
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spec
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a Bl
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ples
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volu
ntee
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ith n
o kn
own
curr
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llnes
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blo
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mal
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See
Tabl
e A4
.8 fo
r det
ails
c
See
Tabl
e A4
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r det
ails
d
Pan
test
line
e P.
viv
ax te
st li
ne
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)94
Tabl
e A
4.11
: Hea
t st
abili
ty t
estin
g re
sult
s fo
r P.
fal
cipa
rum
(or
pan
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est
line
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P. f
alci
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ampl
es a
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w p
aras
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dens
ity
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par
asit
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l).
Posi
tivi
ty r
ate
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asel
ine,
and
aft
er 6
0 da
ys in
cuba
tion
at 4
°C, 3
5°C
and
45°C
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
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rer
Base
line
test
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45°C
4°C
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
Adva
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Qua
lity™
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p M
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915
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02.
015
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02.
015
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015
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15.0
0.0
2.0
15.0
0.0
2.2
15.0
0.0
2.0
13.0
2.0
2.0
13.0
0.0
1.9
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VB
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tech
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15.0
0.0
2.8
15.0
0.0
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15.0
0.0
2.5
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0.0
1.9
15.0
0.0
2.3
15.0
0.0
2.7
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0.0
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03.
215
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04.
015
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04.
015
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04.
015
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04.
014
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04.
015
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04.
015
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T Di
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alar
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115
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02.
915
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02.
115
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02.
515
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02.
015
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02.
015
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02.
915
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02.
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02.
015
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01.
015
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01.
915
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01.
915
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01.
015
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01.
315
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915
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02.
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2.2
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0.0
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15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
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15.0
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0.0
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
1.0
0.0
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0.0
1.0
1.0
0.0
1.0
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02.
015
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01.
715
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01.
413
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01.
212
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615
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01.
514
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01.
413
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0.0
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15.0
0.0
2.0
15.0
0.0
2.0
15.0
0.0
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15.0
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015
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04.
015
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Para
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apid
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2.8
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0.0
2.0
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0.0
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15.0
0.0
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2.8
15.0
0.0
2.2
14.0
0.0
2.0
15.0
0.0
2.9
15.0
0.0
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15.0
0.0
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0.0
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15.0
0.0
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02.
015
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02.
015
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02.
015
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01.
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01.
77.
01.
01.
415
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915
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15.0
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0.0
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0.0
15.0
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0.0
15.0
0.0
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0.0
15.0
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0.0
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0.0
1.0
15.0
0.0
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OTE
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P.f.
& P
an A
g Ra
pid
Test
Kit
RG19
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ote,
Inc.
15.0
0.0
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15.0
0.0
3.0
15.0
0.0
3.4
15.0
0.0
2.9
15.0
0.0
2.6
14.0
0.0
2.1
15.0
0.0
3.0
14.0
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0.0
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15.0
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13.0
0.0
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015
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115
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515
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1.3
4.0
0.0
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11.0
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02.
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0.0
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 95
Prod
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Mean band intensity
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Mean band intensity
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Mean band intensity
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Mean band intensity
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b Re
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f-H
RP2
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pf-p
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)96
Tabl
e A
4.11
a: H
eat
stab
ility
tes
ting
resu
lts
for
pan
test
line
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com
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tion
RDTs
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ple
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par
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l).
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tivi
ty r
ate
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asel
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and
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0 da
ys in
cuba
tion
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°C, 3
5°C
and
45°C
Prod
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Cata
logu
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mbe
r M
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Base
line
test
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35°C
45°C
4°C
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
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Lot
2 (n
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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
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No. invalid
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Pf a
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ne S
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Test
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
BION
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tdN
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/AN
/AN
/AN
/AN
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Pf
MAL
-190
020
Core
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
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M
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
IMM
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TACT
falc
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0519
K25
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Nan
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f Ag
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Para
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apid
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Para
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IC10
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tics
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
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an D
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N/A
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N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
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Pf a
nd P
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IMA-
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
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0.0
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
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& P
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
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0.0
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00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0IM
MU
NOQ
UIC
K CO
NTA
CT M
ALAR
IA +
4 05
25K2
5Bi
osyn
ex0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
01.
00.
01.
0
Mal
aria
Pan
Tes
t M
AL-
W23
N-0
01Di
ma
• G
esel
lsch
aft f
ür
Diag
nost
ika
mbH
0.0
0.0
0.0
4.0
0.0
1.0
9.0
0.0
1.6
7.0
0.0
1.4
7.0
0.0
1.4
5.0
0.0
1.4
6.0
0.0
1.3
2.0
0.0
1.5
Mal
aria
pf (
HRP
II) /
(PAN
-pLD
H) A
ntig
en
Dete
ctio
n Te
st D
evic
e M
FV-1
24R
AZOG
, Inc
.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Mal
aria
pf (
pLDH
) / P
AN-p
LDH
Tes
t Dev
ice
M
FV-1
24AZ
OG, I
nc.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Mal
asca
n™ D
evic
e - R
apid
test
for M
alar
ia P
f/Pan
504
0202
5Ze
phyr
Bio
med
ical
Sys
tem
s0.
00.
00.
00.
01.
00.
00.
00.
00.
00.
00.
00.
00.
01.
00.
02.
00.
01.
02.
00.
01.
00.
00.
00.
0N
anoS
ign
Mal
aria
Pf/
Pan
Ag
RMAP
10Bi
olan
d, L
td0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0N
anoS
ign
Mal
aria
Pf/
Pv A
g -
RMAD
10Bi
olan
d, L
td0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
01.
00.
01.
00.
00.
00.
0
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 97
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35°C
45°C
4°C
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
One
Step
Mal
aria
P.f/
Pan
Test
W
56-C
Guan
gzho
u W
ondf
o Bi
otec
h Co
. Ltd
.0.
00.
00.
00.
00.
00.
01.
00.
01.
010
.00.
01.
010
.00.
01.
412
.00.
01.
00.
00.
00.
00.
00.
00.
0On
Site
Pf/
Pan
Mal
aria
Ag
Rapi
d Te
st
R011
3CCT
K Bi
otec
h, In
c.0.
00.
00.
01.
00.
01.
013
.00.
01.
77.
00.
01.
111
.00.
01.
414
.00.
01.
93.
00.
01.
03.
00.
01.
0Op
tiMAL
-IT
7100
24Di
amed
- A
Div
isio
n of
Bio
-Rad
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
9.0
0.0
1.0
0.0
0.0
0.0
Para
scre
en™
Devi
ce -
Rapi
d te
st fo
r Mal
aria
Pan
/Pf
5031
0025
Zeph
yr B
iom
edic
al S
yste
ms
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
2.0
0.0
1.0
0.0
0.0
0.0
SD B
IOLI
NE
Mal
aria
Ag
P.f/
Pan
05FK
60St
anda
rd D
iagn
ostic
s In
c.0.
00.
00.
00.
00.
00.
00.
01.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0SD
BIO
LIN
E M
alar
ia A
g 05
FK40
Stan
dard
Dia
gnos
tics
Inc.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Sure
step
™ E
asy
Mal
aria
Pf/P
an R
apid
Test
Dev
ice
IMA-
T402
ACON
Bio
tech
(Han
gzho
u) C
o. L
td.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Pf a
nd P
vAd
vanc
ed Q
ualit
y™ O
ne S
tep
Mal
aria
P.f/
P.v
Tri-
Line
Tes
t IT
P110
03 T
C40
InTe
c Pr
oduc
ts, I
nc.
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Adva
ntag
e M
alar
ia C
ard
IR21
1025
J. M
itra
& C
o. P
vt. L
td.
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
BION
OTE
MAL
ARIA
P.f.
& P
.v. A
g Ra
pid
Test
Kit
RG19
-12
Bion
ote,
Inc.
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Core
™ M
alar
ia P
v/Pf
MAL
-190
022
Core
Dia
gnos
tics
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
N/A
Mal
aria
pf (
HRP
II) /
pv
(pLD
H) A
ntig
en
Dete
ctio
n Te
st D
evic
e M
FV-1
24V
AZOG
, Inc
.N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/A
OnSi
te M
alar
ia P
f/Pv
Ag
Rapi
d Te
st
R011
2CCT
K Bi
otec
h, In
c.N
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/AN
/APf
, Pan
and
Pv
Core
™ M
alar
ia P
an/P
v/Pf
M
AL-1
9002
6Co
re D
iagn
ostic
s0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0di
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
0.0
1.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
2.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Pan
only
Clea
rvie
w®
Mal
aria
pLD
H
7088
4025
Orge
nics
Ltd
. (In
vern
ess
Med
ical
In
nova
tions
)14
.01.
01.
015
.00.
01.
014
.00.
01.
114
.00.
01.
115
.00.
01.
915
.00.
02.
015
.00.
01.
015
.00.
02.
0
diag
nost
icks
MAL
ARIA
(Pan
) Cas
sett
e M
PNW
BC10
07.3
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
1.0
0.0
1.0
0.0
0.0
0.0
Para
bank
™ D
evic
e -
Rapi
d te
st fo
r Mal
aria
Pan
503
0102
5Ze
phyr
Bio
med
ical
Sys
tem
s0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Pf: P
lasm
odiu
m fa
lcip
arum
Pv
: Pla
smod
ium
viv
ax
pan:
Pla
smod
ium
spec
ies
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)98
Tabl
e A
4.12
: Hea
t st
abili
ty t
estin
g re
sult
s fo
r P.
fal
cipa
rum
(or
pan
a ) t
est
line
on a
P. f
alci
paru
m s
ampl
es a
t hi
gh p
aras
ite
dens
ity
(2,0
00 p
aras
ites
/µl)
. Po
siti
vity
rat
e at
bas
elin
e, a
nd a
fter
60
days
incu
batio
n at
4°C
, 35°
C an
d 45
°C
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35°C
45°C
4°C
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
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia P
.f Te
stIT
P110
02TC
40In
Tec
Prod
ucts
, Inc
.5.
00.
04.
05.
00.
03.
85.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
0BI
ONOT
E M
ALAR
IA P
.f. A
g Ra
pid
Test
Kit
RG19
-11
Bion
ote,
Inc.
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
4.0
1.0
4.0
3.0
2.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
Clea
rvie
w®
Mal
aria
P.f.
VB
01Vi
sion
Bio
tech
(Pty
) Ltd
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
Core
™ M
alar
ia P
f M
AL-1
9002
0Co
re D
iagn
ostic
s5.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
0IC
T Di
agno
stic
s M
alar
ia P
.f.
ML0
1IC
T Di
agno
stic
s5.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
0IM
MU
NOQ
UIC
K CO
NTA
CT fa
lcip
arum
05
19K2
5Bi
osyn
ex5.
00.
04.
05.
00.
03.
65.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
03.
85.
00.
04.
05.
00.
04.
0N
anoS
ign
Mal
aria
Pf A
g RM
AF10
Biol
and,
Ltd
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
One
Step
Mal
aria
P.F
Tes
t (ca
sset
te)
5223
52Bl
ue C
ross
Bio
-Med
ical (B
eijin
g) C
o., Lt
d.5.
00.
03.
85.
00.
02.
65.
00.
02.
25.
00.
02.
25.
00.
01.
85.
00.
01.
85.
00.
03.
05.
00.
02.
4On
e St
ep M
alar
ia P
.f Te
st
W37
-CGu
angz
hou
Won
dfo
Biot
ech
Co. L
td.
5.0
0.0
3.4
5.0
0.0
4.0
5.0
0.0
2.8
5.0
0.0
3.6
5.0
0.0
4.0
5.0
0.0
3.8
5.0
0.0
4.0
5.0
0.0
3.4
OnSi
te P
f Ag
Rapi
d Te
st
R011
4CCT
K Bi
otec
h, In
c.5.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
03.
85.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
0Pa
rach
eck®
Pf D
evic
e- R
apid
test
for
P. fa
lcip
arum
Mal
aria
Ver
. 3
3030
1025
Orch
id B
iom
edic
al S
yste
ms
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
Para
chec
k® P
f Dip
stic
k- R
apid
test
for
P. fa
lcip
arum
Mal
aria
Ver
. 3
3030
2025
Orch
id B
iom
edic
al S
yste
ms
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
Para
HIT
® -
f (De
vice
) 55
IC10
2-50
Span
Dia
gnos
tics
Ltd.
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
4.0
1.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
Para
HIT
® -f
(Dip
stic
k)
55IC
101-
50Sp
an D
iagn
ostic
s Lt
d.5.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
04.
05.
00.
02.
85.
00.
03.
05.
00.
04.
05.
00.
03.
8SD
BIO
LIN
E M
alar
ia A
g P.
f. (H
RP2/
pLDH
)b05
FK90
Stan
dard
Dia
gnos
tics
Inc.
5.0
0.0
4.0/
1.0
5.0
0.0
4.0/
1.0
5.0
0.0
4.0/
1.0
5.0
0.0
4.0/
1.0
5.0
0.0
4.0/
1.0
5.0
0.0
4.0/
1.0
5.0
0.0
4.0/
1.3
5.0
0.0
4.0/
1.4
Pf a
nd P
anAB
ON M
alar
ia P
an/P
.f. R
apid
Tes
t Dev
ice
IMA-
B402
ABON
Bio
phar
m (H
angz
hou)
Co.
Ltd.
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
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00.
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01.
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eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 99
Prod
uct
Cata
logu
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mbe
r M
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Base
line
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35°C
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Lot
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Lot
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Lot
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Lot
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Lot
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Lot
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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
One
Step
Mal
aria
P.f/
Pan
Test
W
56-C
Guan
gzho
u W
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o Bi
otec
h Co
. Ltd
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00.
03.
05.
00.
03.
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Site
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0.0
4.0
5.0
0.0
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5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
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0.0
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Eas
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05.
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03.
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04.
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and
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4.0
5.0
0.0
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5.0
0.0
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5.0
0.0
3.8
5.0
0.0
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alar
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ard
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J. M
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td.
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0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
BION
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& P
.v. A
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pid
Test
Kit
RG19
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Bion
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5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
Core
™ M
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Core
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5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
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04.
05.
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04.
05.
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04.
05.
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04.
05.
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04.
05.
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04.
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0
OnSi
te M
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Ag
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00.
04.
05.
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04.
05.
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04.
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05.
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04.
04.
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04.
05.
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04.
05.
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04.
05.
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04.
05.
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5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
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Pan
only
Clea
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H
7088
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Orge
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Ltd
. (In
vern
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00.
04.
05.
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03.
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04.
05.
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00.
03.
05.
00.
03.
05.
00.
02.
25.
00.
03.
0
diag
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MAL
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sett
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SSA
Diag
nost
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5.0
0.0
2.0
3.0
0.0
1.3
5.0
0.0
1.8
5.0
0.0
1.8
3.0
0.0
2.0
5.0
0.0
1.6
5.0
0.0
1.6
5.0
0.0
1.6
Para
bank
™ D
evic
e -
Rapi
d te
st fo
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Pan
50
3010
25Ze
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med
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Sys
tem
s4.
00.
02.
05.
00.
02.
05.
00.
02.
05.
00.
01.
65.
00.
01.
65.
00.
01.
65.
00.
01.
85.
00.
01.
6
Pf: P
lasm
odiu
m fa
lcip
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Pv
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smod
ium
viv
ax
pan:
Pla
smod
ium
spec
ies
a Fo
r pan
-onl
y te
sts
b Re
sults
for p
f-H
RP2
line/
pf-p
LDH
line
, res
pect
ivel
y
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)100
Tabl
e A
4.12
a: H
eat
stab
ility
tes
ting
resu
lts
for
pan
test
line
of
com
bina
tion
RDTs
on
a P.
fal
cipa
rum
sam
ple
at h
igh
para
site
den
sity
(20
00 p
aras
ites
/µl)
. Po
siti
vity
rat
e at
bas
elin
e, a
nd a
fter
60
days
incu
batio
n at
4°C
, 35°
C an
d 45
°C
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35°C
45°C
4°C
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
anAB
ON M
alar
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an/P
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apid
Tes
t Dev
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phar
m (H
angz
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Ltd.
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
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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.
5.0
0.0
1.6
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
1.0
4.0
0.0
1.3
2.0
0.0
1.0
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0.0
1.0
Care
Star
t™ M
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regn
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bo
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ss B
io, I
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5.0
0.0
3.0
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0.0
4.0
5.0
0.0
3.0
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
3.6
5.0
0.0
4.0
Care
Star
t™ M
alar
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LDH
3 L
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Test
G
O121
Acce
ss B
io, I
NC.
5.0
0.0
3.8
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
3.8
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
3.8
5.0
0.0
4.0
Care
Star
t™ M
alar
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cree
n G
O231
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ss B
io, I
NC.
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
3.6
5.0
0.0
4.0
5.0
0.0
3.8
5.0
0.0
4.0
5.0
0.0
4.0
5.0
0.0
4.0
Clea
rvie
w®
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aria
Com
bo
VB11
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on B
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ty) L
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00.
01.
05.
00.
01.
00.
00.
00.
02.
00.
01.
00.
00.
00.
00.
00.
00.
01.
00.
01.
04.
00.
01.
0Cl
earv
iew
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alar
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ual T
est D
evic
e VB
20Vi
sion
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tech
(Pty
) Ltd
5.0
0.0
1.6
0.0
0.0
0.0
5.0
0.0
1.0
4.0
0.0
1.0
0.0
0.0
0.0
2.0
0.0
1.0
0.0
0.0
0.0
3.0
0.0
1.0
diag
nost
icks
MAL
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(Pan
/Pf)
Cass
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0.0
0.0
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0.0
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0.0
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Mal
asca
n™ D
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apid
test
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alar
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f/Pan
50
4020
25Ze
phyr
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med
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Sys
tem
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00.
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00.
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alar
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1.8
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0.0
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0.0
1.7
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T 71
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Diam
ed -
A D
ivis
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of B
io-R
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02.
05.
00.
02.
05.
00.
02.
04.
00.
02.
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01.
00.
00.
00.
00.
05.
00.
02.
05.
00.
02.
0Pa
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™ De
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pid
test
for M
alar
ia Pa
n/Pf
5031
0025
Zeph
yr B
iom
edic
al S
yste
ms
4.0
0.0
1.0
5.0
0.0
1.0
5.0
0.0
2.0
5.0
0.0
1.4
5.0
0.0
1.6
5.0
0.0
1.2
5.0
0.0
2.0
5.0
0.0
2.0
SD B
IOLI
NE
Mal
aria
Ag
P.f/
Pan
05FK
60St
anda
rd D
iagn
ostic
s In
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00.
02.
05.
00.
01.
45.
00.
01.
02.
00.
01.
04.
00.
01.
05.
00.
01.
45.
00.
01.
25.
00.
01.
0SD
BIO
LIN
E M
alar
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g 05
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Stan
dard
Dia
gnos
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5.0
0.0
1.0
3.0
0.0
1.0
0.0
0.0
0.0
2.0
0.0
1.0
5.0
0.0
1.0
4.0
0.0
1.0
5.0
0.0
1.2
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0.0
1.4
Sure
step
™ E
asy
Mal
aria
Pf/P
an R
apid
Test
Dev
ice
IMA-
T402
ACON
Bio
tech
(Han
gzho
u) C
o. L
td.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Pf, P
an a
nd P
vCo
re™
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aria
Pan
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Pf
MAL
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026
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3.0
0.0
1.0
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0.0
1.0
5.0
0.0
1.0
0.0
1.0
0.0
3.0
0.0
1.0
4.0
0.0
1.3
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0.0
1.0
3.0
0.0
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ARIA
(Pan
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Pf) C
asse
tte
MPN
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007.
5SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s5.
00.
01.
02.
00.
01.
50.
00.
00.
00.
00.
00.
01.
00.
01.
04.
00.
01.
03.
00.
01.
33.
00.
01.
0
Pf: P
lasm
odiu
m fa
lcip
arum
Pv
: Pla
smod
ium
viv
ax
pan:
Pla
smod
ium
spec
ies
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 101
Tabl
e A
4.13
: Hea
t st
abili
ty t
estin
g re
sult
s fo
r P.
fal
cipa
rum
(or
pan
) te
st li
ne o
n pa
rasi
te n
egat
ive
sam
ples
. Pos
itivi
ty r
ate
at b
asel
ine,
and
aft
er 6
0 da
ys in
cuba
tion
at 4
°C, 3
5°C
and
45°C
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35°C
45°C
4°C
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.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
Pf o
nly
Adva
nced
Qua
lity™
One
Ste
p M
alar
ia P
.f Te
stIT
P110
02TC
40In
Tec
Prod
ucts
, Inc
.1.
00.
01.
00.
00.
00.
00.
00.
02.
00.
04.
00.
00.
00.
01.
00.
0BI
ONOT
E M
ALAR
IA P
.f. A
g Ra
pid
Test
Kit
RG19
-11
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ote,
Inc.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Clea
rvie
w®
Mal
aria
P.f.
VB
01Vi
sion
Bio
tech
(Pty
) Ltd
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Core
™ M
alar
ia P
f M
AL-1
9002
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re D
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00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
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T Di
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alar
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00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
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00.
00.
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MU
NOQ
UIC
K CO
NTA
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05
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00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
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anoS
ign
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aria
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g RM
AF10
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and,
Ltd
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
One
Step
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P.F
Tes
t (ca
sset
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ue C
ross
Bio
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.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
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e St
ep M
alar
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st
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zhou
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td.
0.0
0.0
0.0
0.0
1.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
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te P
f Ag
Rapi
d Te
st
R011
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K Bi
otec
h, In
c.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0Pa
rach
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evic
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apid
test
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. fal
cipa
rum
M
alar
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30
3010
25Or
chid
Bio
med
ical
Sys
tem
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00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Para
chec
k® P
f Dip
stic
k- R
apid
test
for
P. fa
lcip
arum
Mal
aria
Ver
. 3
3030
2025
Orch
id B
iom
edic
al S
yste
ms
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Para
HIT
® -
f (De
vice
) 55
IC10
2-50
Span
Dia
gnos
tics
Ltd.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Para
HIT
® -f
(Dip
stic
k)
55IC
101-
50Sp
an D
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ostic
s Lt
d.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
01.
00.
00.
00.
00.
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BIO
LIN
E M
alar
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g P.
f. (H
RP2/
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dard
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Pf a
nd P
anAB
ON M
alar
ia P
an/P
.f. R
apid
Tes
t Dev
ice
IMA-
B402
ABON
Bio
phar
m (H
angz
hou)
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Ltd
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00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0BI
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E M
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st K
it RG
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00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
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ombo
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00.
00.
00.
00.
00.
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00.
00.
00.
00.
00.
00.
00.
00.
0
Care
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alar
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
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alar
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n G
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ss B
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
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bo
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on B
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ch (P
ty) L
td0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0Cl
earv
iew
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alar
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ual T
est D
evic
e VB
20Vi
sion
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tech
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) Ltd
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
diag
nost
icks
MAL
ARIA
(Pan
/Pf)
Cass
ette
M
PNFW
BC10
07.4
SSA
Diag
nost
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& B
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ch S
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ms
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
ICT
Diag
nost
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aria
Com
bo
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T Di
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stic
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00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
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T Di
agno
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alar
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00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
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MU
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00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
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an T
est
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ma
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0.0
0.0
1.0
0.0
0.0
0.0
1.0
0.0
1.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Mal
aria
pf (
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ntig
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st D
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00.
00.
00.
00.
00.
00.
01.
00.
00.
00.
00.
00.
00.
00.
00.
0
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pf (
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AN-p
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Mal
asca
n™ D
evic
e -
Rapi
d te
st fo
r Mal
aria
Pf/
Pan
5040
2025
Zeph
yr B
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edic
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ms
0.0
1.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Nan
oSig
n M
alar
ia P
f/Pa
n Ag
RM
AP10
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and,
Ltd
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
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n M
alar
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f/Pv
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and,
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
One
Step
Mal
aria
P.f/
Pan
Test
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0.0
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0.0
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Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)102
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35°C
45°C
4°C
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.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
Para
scre
en™
Dev
ice
- Ra
pid
test
for M
alar
ia P
an/P
f50
3100
25Ze
phyr
Bio
med
ical
Sys
tem
s1.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0SD
BIO
LIN
E M
alar
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g P.
f/Pa
n 05
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Stan
dard
Dia
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Inc.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
SD B
IOLI
NE
Mal
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Ag
05FK
40St
anda
rd D
iagn
ostic
s In
c.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0Su
rest
ep™
Eas
y M
alar
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f/Pa
n Ra
pid
Test
Dev
ice
IMA-
T402
ACON
Bio
tech
(Han
gzho
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o. L
td.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Pf a
nd P
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vanc
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ualit
y™ O
ne S
tep
Mal
aria
P.f/
P.v
Tri-
Line
Tes
t IT
P110
03 T
C40
InTe
c Pr
oduc
ts, I
nc.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Adva
ntag
e M
alar
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ard
IR21
1025
J. M
itra
& C
o. P
vt. L
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
BION
OTE
MAL
ARIA
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& P
.v. A
g Ra
pid
Test
Kit
RG19
-12
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ote,
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Core
™ M
alar
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v/Pf
MAL
-190
022
Core
Dia
gnos
tics
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Mal
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pf (
HRP
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pv
(pLD
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ntig
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tion
Test
Dev
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MFV
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
OnSi
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Ag
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0Pf
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Pan
only
Clea
rvie
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Mal
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H
7088
4025
Orge
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Ltd.
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04.
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00.
00.
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00.
00.
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00.
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0Pa
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Dev
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- Ra
pid
test
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alar
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5030
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yr B
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Pf: P
lasm
odiu
m fa
lcip
arum
Pv
: Pla
smod
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viv
ax
pan:
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smod
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a Bo
th p
f-H
RP2
and
pf-p
LDH
test
line
s in
divi
dual
ly re
turn
ed 0
% p
ositi
vity
rate
s
Tabl
e A
4.13
(co
ntin
ued)
ann
eXe
s
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011) 103
Tabl
e A
4.13
a: H
eat
stab
ility
tes
ting
resu
lts
for
pan
test
line
of
com
bina
tion
RDTs
on
para
site
neg
ativ
e sa
mpl
es. P
ositi
vity
rat
e at
bas
elin
e, a
nd a
fter
60
days
incu
batio
n at
4°C
, 35°
C an
d 45
°C
Prod
uct
Cata
logu
e nu
mbe
r M
anuf
actu
rer
Base
line
test
ing
35°C
45°C
4°C
Lot
1 (n
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Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
=4)
Lot
1 (n
=4)
Lot
2 (n
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Lot
1 (n
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Lot
2 (n
=4)
No.
posit
ive
No.
inva
lidNo
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sitiv
eNo
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valid
No.
posit
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No.
inva
lidNo
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sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
No.
posit
ive
No.
inva
lidNo
. po
sitiv
eNo
. in
valid
Pf a
nd P
anAB
ON M
alar
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an/P
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apid
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t Dev
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00.
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00.
00.
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0
Care
Star
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alar
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G
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0.0
0.0
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0.0
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0.0
0.0
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0.0
0.0
0.0
0.0
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0.0
0.0
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Clea
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Com
bo
VB11
Visi
on B
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ch (P
ty) L
td0.
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00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
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00.
00.
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0Cl
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ual T
est D
evic
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20Vi
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
diag
nost
icks
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ARIA
(Pan
/Pf)
Cass
ette
M
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SSA
Diag
nost
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& B
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ms
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
ICT
Diag
nost
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Mal
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Com
bo
ML0
2IC
T Di
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00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
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T Di
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s M
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00.
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00.
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an T
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0.0
0.0
2.0
0.0
1.0
0.0
2.0
0.0
2.0
0.0
4.0
0.0
2.0
0.0
2.0
0.0
Mal
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pf (
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(PAN
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ntig
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Dete
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st D
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00.
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00.
00.
00.
00.
01.
00.
00.
00.
00.
00.
00.
00.
00.
0
Mal
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pf (
pLDH
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AN-p
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Tes
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M
FV-1
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OG, I
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Mal
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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
0.0
1.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Nan
oSig
n M
alar
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f/Pa
n Ag
RM
AP10
Biol
and,
Ltd
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Nan
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n M
alar
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
One
Step
Mal
aria
P.f/
Pan
Test
W
56-C
Gua
ngzh
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ondf
o Bi
otec
h Co
. Ltd
.0.
01.
01.
00.
00.
01.
00.
01.
04.
00.
04.
00.
00.
00.
00.
00.
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03.
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03.
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03.
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03.
00.
01.
00.
00.
00.
0Op
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Div
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Para
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Dev
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- Ra
pid
test
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alar
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00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0SD
BIO
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alar
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f/Pa
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Stan
dard
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0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
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c.0.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0Su
rest
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Eas
y M
alar
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f/Pa
n Ra
pid
Test
Dev
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IMA-
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tech
(Han
gzho
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td.
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
Pf, P
an a
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vCo
re™
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aria
Pan
/Pv/
Pf
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-190
026
Core
Dia
gnos
tics
0.0
0.0
0.0
0.0
0.0
1.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
0.0
diag
nost
icks
MAL
ARIA
(Pan
/Pv/
Pf) C
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tte
MPN
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007.
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A Di
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tech
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00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
00.
0
Pf: P
lasm
odiu
m fa
lcip
arum
Pv
: Pla
smod
ium
viv
ax
pan:
Pla
smod
ium
spec
ies
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)104
annex 5a: selection of an appropriate rdt
Step 1.1Definesettingofuse
What ?targetparasitespeciesandantigena
Pf or mixed Pf/non-Pf infections:- HRP2- pLDH-Pf
Pf or non-Pf infectionsb:- 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-P vom
P.vivax, only:- aldolase- pLDH-pan- pLDH-Pv
**Pf with absent HRP2–DONOTUSEHRP2basedRDTsc
Where ? Exposurehightemperatureeg.tropicalenvironmentORTemperaturecontrolledenvironment,includingduringtransportandstorage
Who? LaboratorypersonnelORHealthworkersoutsideoflaboratories
Step 1.2Review RDT performance
WHO RDT Product Testing resultsdandapplyWHOrecommendedRDTselectioncriteriae
- Panel Detection Score (PDS)- False Positivity Rate (FPR)- Invalid Rate (IR)- Ease of use- Thermal stability- Ease of use
Sensitivity and specificity based on quality field studies in relevant populations
Generate RDT short list
Step 1.3Apply national guidelines and experience in use of RDTs
National malaria treatment guidelines
In-country experience: ease of use assessments (Annex 5b); availability of training materials
Step 1.4Other considerations
- Price- Supplier’s: production capacity, lead times, heat stability data- Delivery schedules (eg. staggered deliveries), box size, shelf life- Registration requirements of a national regulatory authorities- Product lot testing results- Overall budget requirements (Annex 6)
a Pf only or mixed Pf/non Pf infections: Most area of sub-Saharan Africa and lowland Papua New Guinea; : Pf and non-Pf invfections (single species): Most endemic areas of Asia and the Americas and isolated areas of the Horn of Africa; Mainly vivax-only: areas of East Asia, central Asia, South America, and some highland areas elsewhere
b Tests with a falciparum-specific line and pan-specific line will not distinguish P. falciparum-only infections from mixed falciparum infections. Distinguishing falciparum from mixed falciparum-vivax infections only becomes important 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 to detect these (eg. Pf-Pv-pan) increases complexity of test interpretation. A programme should prioritize these various advantages and dis-advantages according to local conditions in the initial stage of making procurement decisions.
c P. falciparum parasites lacking HRP2 +/- HRP3 genes have been identified in parts of South America (Gamboa D et al. PLoS ONE 5(1):e8091.doi:10.1371/journal.pone.000809)d Malaria Rapid Diagnostic Test Performance: Results of WHO product testing of malaria RDTs: Round 1(2008); Round 2 (2009); Round 3 (2010); FIND Malaria RDT Product
Testing: Interactive Guide - http://www.finddiagnostics.org/programs/malaria/find_activities/product_testing/malaria-rdt-product-testing/e WHO RDT procurement criteria : http://www.who.int/malaria/diagnosis_treatment/diagnosis/RDT_selection_criteria.pdf (accessed 6 September, 2011)
ForacomprehensiveguidetoprocurementofmalariaRDTsextendingbeyondselectiontoquantification,budgeting,technicalspecifications,managementoftenders,contracts,supplymanagementandmonitoringofsupplierperformanceandmanagingproductvariations,seethe“GoodPracticesforselectingandprocuringrapiddiagnostictestsformalaria”(6)
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annex 5b: rdt format review and ease of use assessmentObtainsamplesofeachmalariaRDTunderconsideration(atleast1boxpackagedasintendedforfinaldelivery)
Obtainnegativebloodsamples,andwherereadilyaccessible,parasitepositivebloodsamplesfortestingagainstRDTs.Thepurposeofanevaluationonalimitednumberoftestsistoassessaspectsofease-of-useandtoscreenformajortestanomalies,asdescribedinthetablebelow,and not to assess diagnostic accuracy.
Device and components of kit
Features to look for in product review and ease-of-use assessment
Teststrip •Goodclearanceofbloodbytimeofreading•Evenflowofbloodupstrip
Testlines •‘ghostline’–sometimesafaintlinecanbeseenbeforethetestisused•False-positives:bloodproductssticktoline,givinganimpressionofapositiveresult•Verythinorincompletelinesinpositivecases,orspreadingoflinecolouralongstrip
(‘leaching’)
Controllines •Aswithtestlines
RDTbuffer •Variabledropsize•Leakagefrombottles•Overflowofbufferfromwelloncassettewhencorrectnumberofdropsareapplied.
Structuralissues Shiftingofstripsinsidecassette
Bloodtransferdevice •Bloodsafetyfeatures•Ease-of-use
OtherQCissues a)Notenoughbufferprovidedb)Notesttubesprovidedc)Cassetteisdamaged/Missingpartsd)Cassettehasnoidentifierse)Boxismissinginstructions/Instructionsaren’tclearf)Conditionofboxes–thosewithoutnaturaldisasterexcusesg)Testsaren’talways“easyopen”
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)106
Asparasite-baseddiagnosisisintroducedatsmallerclinicsandvillagelevelforcasemanagement,alargenumberofchallengesarisenotonlyinlogisticaladministrationbutalsoinmanagingthehealth-seekingandhealth-providingbehaviourofpatientsandhealthworkers.Thesecanbeaddressedbyasystematicapproachtoplanning,imple-mentation,monitoringandevaluationofthediagnosticprogramme;aprocessthatmustcommencewellbeforeRDTsareprocured.ExamplesofwidescalesuccessfulintroductionofmalariaRDTsarenowinexistenceinvariousnationalprogrammes(26).ThefollowinginformationisderivedfromexistingWHOdocumentsaddressingthisarea.27AmalariaRDTImplementationmanualtoguidenationalprogrammesinthisareaisnearingcompletionandwillbeaccessibleatwww.wpro.who.int/sites/rdtandwww.finddiagnostics.org/resource-centre/reports_brochures/.
Manyhealthworkersandcommunitieswillhavebeentaughtthat“feverequalsmalariaunlessprovenotherwise”.IntroducingRDTswilldemonstratethatthisisnotthecase.Tohaveanimpactonanti-malarialdiagnosisandtreatment,RDTsmustbeseentoprovideanaccuratediagnosisbybothhealthworkersandpatientsalike,thatis,theymustbeasgoodorbetterthanthosereliedonpreviously.Ahealthworkerwillalsoneedagoodalternativetoanti-malarialmedicinesforthemanagementofparasite-negativefebrilepatients.ToachieveandmaintainconfidenceinRDT-baseddiagnosis,agoodqualityassurancesystemmustbeinplace(detailedelsewhereonthiswebsite).Theremustbesatisfactoryeducationofhealthworkers,andwidespreadcommunitysensitization.Knowledgeofothercausesoffeverwillbenecessarytodevelopappropriatemanagementalgorithmsforparasite-negativecases.
27DevelopedbyWHORegionalOfficefortheWesternPacificandtheWHOGlobalMalariaProgramme,with support fromtheUgandaMinistryofHealth(NationalMalariaControlProgramme),ManagementSciencesforHealth(MSH),andotherpartners.
Atthenationallevel,regulatoryrequirementsmayneedtobedevelopedtocontroltheimportationanduseofmalariaRDTs,andnewproceduresforstorage,distributionandinventorymanagement,suchasthoseusedformedicines,mayneedtobedeveloped.Ifchangingfromadifferentproductormodeofdiagnosis,anadequatephase-outplanforthismustalsobedeveloped.
ThisrequiresaclearstrategicplantobedevelopedwellinadvanceofRDTintroduction,withacleartimelinetoensurethatthevariouscomponentsoftheRDTprogrammeareinplaceattherighttime.Afocalperson,orpersons,willbeneededtocoordinatetheoverallimplementationplanandensurethatthevariousagenciesthatmaybeinvolvedunderstandtheprocessandtheirparticularroles.Toachievethis,fundingfortheprogrammemustincludeasignificantcomponentforplanningandcoordination,sensitization/IEC,training,qualityassurance,monitoringandsupervision,andlogistics,inadditiontoprocurement.Withoutthis,muchofthefundsexpendedonRDTsmaybewasted,andalossofconfidenceinRDT-baseddiagnosismayhindertheprocessofstrengtheningappropriatemalariacasemanagement.
Anexampleofanationalimplementationplanisshownonthefollowingpages.Thiswillneedtobemodifiedconsider-ablyforeachprogramme,preferablythroughacollaborativeprocessinvolvingallthemajoragenciesconcernedinitsimplementation.Budgetingforallthecomponentsoftheprogrammeattheoutsetisvital.AnexampleofcomponentstobeconsideredinanoverallbudgetisshowninFigureA6.1.
annex 6: introducing rdt-based malaria diagnosis into national programmes
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Summary of introduction plan (see following page)
Program planning and management Identifykeystakeholders,andsecurecommitmentforintroductionofRDTs
Establishworkinggroupanddeveloptermsofreference
Identifyspecificfocalperson(s)responsiblefordaytodayoversightoftheimplementationplan
Developatimeline,scope,andbudgetforimplementation
Identifyhumanandotherresourceneeds,andastrategyforaccessingthem
Reviewandupdate,ifneeded,case-managementalgorithmsformalariaandothercausesoffebrileillness
Policy and regulatory issues Developappropriateregulatorydocumentsifrequired
RegisterRDTproducts
Procurement of RDTs Developproductspecificationsandpackagingrequirements
Developproductshort-list
Conductquantification(estimationofneeds)
ProcureRDTs
Procuresharpsboxes,glovesetc.
Logistics Developdistributionplan
TrainlogisticsandstoragepersonnelinhandlinganddistributionofRDTs
Implementasystemfordatacollectionandinformationflows
Arrangeforappropriatetransportandstorage
Reviewandstrengtheninventorymanagement,asneeded
Developaplanfordiscontinuationanddisposalofotherdiagnosticsupplies,ifappropriate
Quality Assurance Developmechanismsforassessingsamplesatanationallevel(lot-testing),andregular(andrandom)testingatthe
levelofuse(e.g.microscopy-sentinelsites)
Implementpost-marketingsurveillance
Training and communication Developappropriatetrainingandsupervisionmaterials
Trainhealthworkersincasemanagementandmanagingcommodities
TraininRDTuse
Developandimplementaprogramforcommunityeducation/sensitization
Monitoring and Evaluation Implementeffectivesupervisionandmonitoring Strengthenrecordingandreportingprocedures
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)108
Reco
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Figure A6.1 Example malaria RDT implementation budget
BelowisanexampleofmajorcomponentsofaprogrammebudgettobeconsideredwhenintroducingRDTsintoamalariaprogramme.Withoutadequateprovisionforeachofthesefactors,itislikelythatanRDT-baseddiagnosticsprogrammewillfailtoachieveitsgoals.Thesecomponentsshouldthereforebeaddressedinproposalsforprogrammefunding,orprovisionsshouldbemadeforthemincollaboratingprogrammes.
Monitoring accuracy in field
Training and supervision
Testing and laboratory monitoring
Training, drugs / supplies for non-malarial fever
Community education
Procurement of gloves, sharps disposal containers etc.
Procurement of RDTs
Transport and storage
Malaria rapid diagnostic test perforMance – results of WHo product testing of malaria rdts: round 3 (2010-2011)110
notes
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Mala
ria R
apid
Diag
nost
ic Te
st Pe
rform
ance
Re
sults
of W
HO p
rodu
ct te
sting
of m
alaria
RDT
s: Ro
und
3 (2
010-
2011
)TDR/World Health Organization20,AvenueAppia1211Geneva27Switzerland
Fax:(+41)[email protected]/tdr
FINDAvenuedeBudé161202GenevaSwitzerland
Fax:(+41)[email protected]
ISBN9789241502566
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