malaria rapid diagnostic test performance – results
If you can't read please download the document
TRANSCRIPT
-
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)
Copyright World Health Organization on behalf of the Special Programme for Research and Training in Tropical Diseases 2011
All rights reserved.The use of content from this health information product for all non-commercial education, training and information purposes is encouraged, including translation, quotation and reproduction, in any medium, but the content must not be changed and full acknowledgement of the source must be clearly stated. A copy of any resulting product with such content should be sent to TDR, World Health Organization, Avenue Appia, 1211 Geneva 27, Switzerland. TDR is a World Health Organization (WHO) executed UNICEF/UNDP/World Bank/World Health Organization Special Programme for Research and Training in Tropical Diseases.
This information product is not for sale. The use of any information or content whatsoever from it for publicity or advertising, or for any commercial or income-generating purpose, is strictly prohibited. No elements of this information product, in part or in whole, may be used to promote any specific individual, entity or product, in any manner whatsoever.
The designations employed and the presentation of material in this health information product, including maps and other illustrative materials, do not imply the expression of any opinion whatsoever on the part of WHO, including TDR, the authors or any parties cooperating in the production, concerning the legal status of any country, territory, city or area, or of its authorities, or concerning the delineation of frontiers and borders.Mention or depiction of any specific product or commercial enterprise does not imply endorsement or recommendation by WHO, including TDR, the authors or any parties cooperating in the production, in preference to others of a similar nature not mentioned or depicted.
WHO, including TDR, and the authors of this health information product make no warranties or representations regarding the content, presentation, appearance, completeness or accuracy in any medium and shall not be held liable for any damages whatsoever as a result of its use or application. WHO, including TDR, reserves the right to make updates and changes without notice and accepts no liability for any errors or omissions in this regard. Any alteration to the original content brought about by display or access through different media is not the responsibility of WHO, including TDR, or the authors. WHO, including TDR, and the authors accept no responsibility whatsoever for any inaccurate advice or information that is provided by sources reached via linkages or references to this health information product.
Layout: Bruno Duret
Printed in Malta
-
Malaria rapid diagnostic test perforMance results of WHo product testing of malaria rdts: round 3 (2010-2011) I I I
Contents acknoWledgeMents ViiiabbreViations 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/l)andclean-negativesamples
Figure S2: MalariaRDTperformanceinPhase2ofRounds1-3againstwild-type(clinical)samplescontainingP. vivax atlow(200)andhigh(2000or5000)parasitedensities(parasites/l)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: TestingprocedureandcalculationofpaneldetectionscoreandbandintensityforProductAagainstasampledensityof200parasites/l
Figure 6: TestingprocedureandcalculationofpaneldetectionscoreandbandintensityforProductAagainstasampledensityof2000parasites/l
Figure 7: Phase1P. falciparumpaneldetectionscoreofmalariaRDTsatlow(200)andhigh(2000)parasitedensities(parasites/l)accordingtotargetantigentype(HRP2orpLDH)
Figure 8: Phase2P. falciparumpaneldetectionscoreofmalariaRDTsatlow(200)andhigh(2000)parasitedensity(parasites/l)accordingtotargetantigentype(HRP2orpLDH)
Figure 9: Phase2P. vivaxpaneldetectionscoreofmalariaRDTsatlow(200)andhigh(2000)parasitedensities(parasites/l)accordingtotargetantigentype(aldolase,pLDH)
Figure 10: Phase2P. falciparumpaneldetectionscoreandpositivityrateat200parasites/l
Figure 11: Phase2P. vivaxpaneldetectionscoreandpositivityrateat200parasites/l
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/l)
Figure 15: Phase2P. vivaxfalse-positiverateversusP. vivaxpaneldetectionscoreatlow(200)parasitedensity(parasites/l)
Figure 16: HeatstabilityofP. falciparum-specifictestlineofP. falciparum-onlytestsagainstalowdensityP. falciparumsample(200parasites/l).Positivityrateatbaseline,andafter60daysincubation
Figure 17: HeatstabilityofP. falciparum-specifictestlineofP. falciparum-onlytestsagainstahighdensityP. falciparumsample(2000parasites/l).Positivityrateatbaseline,andafter60daysincubation
Figure 18: HeatstabilityofP. falciparum-specifictestlineincombinationtestsagainstalowdensityP. falciparum sample(200parasites/l).Positivityrateatbaseline,andafter60daysincubation
Figure 19: HeatstabilityofP. falciparumspecifictestlineincombinationtestsagainstahighdensityP. falciparum sample(2000parasites/l).Positivityrateatbaseline,andafter60daysincubation
Figure 20: Heatstabilityofpan-lineofpan-specifictestsagainstalowdensityP. falciparumsample(200parasites/l).Positivityrateatbaseline,andafter60daysincubation
Figure 21: Heatstabilityofpan-lineofpan-specifictestsagainstahighdensityP. falciparumsample(2000parasites/l).Positivityrateatbaseline,andafter60daysincubation
Figure 22: Heatstabilityofpan-lineofcombinationtestsagainstalowdensityP. falciparumsample(200parasites/l).Positivityrateatbaseline,andafter60daysincubation
Figure 23: Heatstabilityofpan-lineofcombinationtestsagainstahighdensityP. falciparumsample(2000parasites/l).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/l)andclean-negativesamples
Table S2: MalariaRDTRounds1-3heatstabilityresultsonacultured P. falciparum sampleatlow(200)andhigh(2000)parasitedensity(parasites/l).Positivityrateatbaseline,andafter60daysincubationat35Cand45C
Table S3: Productresubmissions:WHOMalariaRDTProductTesting(Rounds1-3)
Table 1: ManufacturersandproductsacceptedintoRound3ofWHOMalariaRDTProductTestingProgramme
Table 2: CharacteristicsofPlasmodiumspp.negativespecimens
Table 3: SummaryPhase1performanceof50malariaRDTsagainst20culturedP. falciparumlinesatlow(200)andhigh(2000)parasitedensities(parasites/l)
Table 4: SummaryPhase2performanceof50malariaRDTsagainstwild-type(clinical)P. falciparumandP. vivaxsamplesatlow(200)andhigh(2000)parasitedensities(parasites/l)andPlasmodiumspp.negativesamples
Table 5: Heatstabilitytestingresultsfor50malariaRDTsonaculturedP. falciparumsampleatlow(200)andhigh(2000)parasitedensities(parasites/l).Positivityrateatbaseline,andafter60daysincubationat35Cand45C
Table 6: Easeofusedescriptionof50malariaRDTs
Table A3.1: LotvariabilityinpositiveresultsagainstP. falciparumculturesamplesatlow(200)andhigh(2000or5000)parasitedensities(parasites/l)
Table A3.2: Distributionoftestbandintensityscores(0-4)againstPhase1P. falciparumculturedparasitesatlow(200)andhigh(2000)parasitedensities(parasites/l)
Table A4.1: LotvariabilityinpositiveresultsagainstPhase2wild-typeP. falciparumandP. vivaxsamplesatlow(200)andhigh(2000)parasitedensities(parasites/l)
Table A4.2: Distributionoftestbandintensity(0-4)scoresagainstPhase2wild-typeP. falciparumsamplesatlow(200)andhigh(2000)parasitedensities(parasites/l)
Table A4.3: DistributionofPan/Pvtestbandintensity(0-4)scoresforPhase2wild-typeP. vivaxsamplesatlow(200)andhigh(2000)parasitedensities(parasites/l)
Table A4.4: PaneldetectionscoreofPhase2wild-typeP. falciparuminlow(200)andhigh(2000)parasitedensities(parasites/l)bycontinent
Table A4.5: Phase2P. falciparumtestlinefalse-positiveratesforwild-typeP. vivaxsamplesatlow(200)andhigh(2000)parasitedensities(parasites/l)
Table A4.6: Phase2Pan(orP. vivax)testlinefalse-positiveratefornon-Pfinfectiononwild-typeP. falciparumsamplesatlow(200)andhigh(2000)parasitedensities(parasites/l)
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/l).Positivityrateatbaseline,andafter60daysincubationat4C,35Cand45C
Table A4.11a: HeatstabilitytestingresultsforpantestlineofcombinationRDTsonaP. falciparumsampleatlowparasitedensity(200parasites/l).Positivityrateatbaseline,andafter60daysincubationat4C,35Cand45C
Table A4.12: HeatstabilitytestingresultsforP. falciparum(orpan)testlineonaP. falciparumsampleathighparasitedensity(2000parasites/l).Positivityrateatbaseline,andafter60daysincubationat4C,35Cand45C
-
Malaria rapid diagnostic test perforMance results of WHo product testing of malaria rdts: round 3 (2010-2011) VII
Table A4.12a: HeatstabilitytestingresultsforpantestlineofcombinationRDTsonaP. falciparumsampleathighparasitedensity(2000parasites/l).Positivityrateatbaseline,andafter60daysincubationat4C,35Cand45C
Table A4.13: HeatstabilitytestingresultsforP. falciparum(orpan)testlineonparasite-negativesamples.Positivityrateatbaseline,andafter60daysincubationat4C,35Cand45C
Table A4.13a: HeatstabilitytestingresultsforpantestlineofcombinationRDTsonparasite-negativesamples.Positivityrateatbaseline,andafter60daysincubationat4C,35Cand45C
-
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 WHORegionalOfficefortheWesternPacific,ThePhilippines
Djibrine Djalle InstitutPasteurBangui,CentralAfricanRepublic
Babacar Faye UniversitCheikhAntaDIOP,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 MdecinsSansFrontires,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 CentroInternacionaldeEntrenamientoeInvestigacionesMdicas(CIDEIM),Colombia
Sina Nhem InstitutPasteur/NationalMalariaCentre(CNM),Cambodia
Bernhards Ogutu KenyaMedicalResearchInstitute(KEMRI),Kenya
Pamela Onyor KenyaMedicalResearchInstitute(KEMRI),Kenya
Daniel Orozco MdecinsSansFrontires,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/L 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
Y r
oU
nd
s 1-
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. introductionTheWorldHealthOrganizationestimatesthathalftheworldspopulationareatriskofmalaria,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)
http://www.wpro.who.int/internet/resources.ashx/RDT/docs/pdf_version/web3_QARDTreport.pdfhttp://www.wpro.who.int/internet/resources.ashx/RDT/docs/pdf_version/web3_QARDTreport.pdfhttp://www.wpro.who.int/internet/resources.ashx/RDT/docs/pdf_version/web3_QARDTreport.pdf -
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/l)andahigherparasitedensity(2000or5000parasites/l).Theformeriswellbelowthemeanparasitedensityfoundinmanypopulationswithendemicmalaria,andconsideredclosetothethresholdthattestsmustdetecttoreliablyidentifyclinicalmalariainmanysettings.5Forthepurposesofthisreport,themainmeasureofperform-anceisthepaneldetectionscore(PDS)6;thepercentageofmalariasamplesinthepanelgivingapositiveresultbytwoRDTsperlotatthelowerparasitedensity,andasingleRDTperlotatthehigherparasitedensity.Thus,itisnotameasureofRDTclinicalsensitivity,orpositivityrateagainstthepanelbutratheracombinedmeasureofpositivityrate,alongwithinter-testandinter-lotconsistency.Thefiguresalsoshowthefalse-positiveratesagainstbloodsamplescontainingnomalariaparasitesorknownmarkersofotherdiseases,andtherateatwhichinvalidresultsoccurred.
TheclinicalsensitivityofanRDTtodetectmalariaishighlydependentonthelocalconditions,includingparasitedensityinthetargetpopulation.Sensitivityofatestwillthereforedifferbetweenpopulationswithdifferinglevelsoftransmission,astheirdifferentlevelofimmunitywillaffecttheparasitedensityatwhichtheyexhibitsymptomswarrantingadiagnostictest.Wheretransmissionratesarelow,parasitedensitiesinpeoplewithsymptomsofmalariaarelikelytobelower,resultingintestshavingalowersensitivity.Forthisreason,testperform-anceat200parasites/lisparticularlyimportant.TheresultsinthisreportshowcomparativeperformancebetweenRDTs,andgiveanindicationofwhichproductsarelikelytoprovidehighersensitivityinthefield,particularlyinpopulationswithlow-densityinfections.Ingeneral,ascountriesreducemalariaprevalenceandevenmovetowardsmalariaelimination,detectionoflowparasitedensitiesbecomesincreasinglyimportantincasemanagement.Asthedetectionrateat2000parasites/lindicates,thesensitivityofmanyoftheseproductswillbesimilarinpopulationswithhigherparasitedensities,althoughasubsetofanypopulationwillincludevulnerableindividualswhomaydevelopillnessatlowparasitedensities(e.g.youngchildren,pregnantwomen,thosewellprotectedbybednets)andmustalwaysbetakenintoaccountwheninterpretingRDTresults.AnimportantcaveatwhenpredictingfieldsensitivityfromthePDSprovidedinthisreportisthatthepanelsusedinthisevaluationonlyincludeparasitesknowntoexpressthetargetantigens.Whilenon-expressionofthetargetantigenshasnotbeenrecordedforaldolaseorpLDH,itisknownthatparasitesinfectingpeopleinsomeareasofSouthAmericadonotexpressHRP27.InareaswhereHRP2-deletedparasitesexist,HRP2-detecting
5 Parasitological Confirmation of Malaria Diagnosis. ReportofaWHOtechnicalconsultationGeneva,68October2009. Geneva,WorldHealthOrganization,2010.ISBN9789241599412
6 TermedDetectionRateinthefullreportofRound1,publishedin2009.SeetheRound3reportforafullexplanationofthepaneldetectionscore(PDS).
7 GamboaDetal.PLoS One,2010:5(1):e8091
testswillhavegreatlyreducedsensitivityorbeincapableofdetectingP. falciparum.Insuchpopulations,onlytestsdetectingpLDHinP. falciparumparasiteswillbeeffectiveindiagnosingfalciparummalaria.
Heatstability(summarizedinTableS2)isvitaltomaintainingsensitivityofthetestinthefield.Asaresult,forprocurement,itisessentialthatcarefulconsiderationbegiventostabilityresultstoensurethatproductstobeusedinareaswithhightemperaturesoftransportandstoragehavedemonstratedstabilityintheproducttestingprogramme.Requirementswillvarybetweencountries:forexample,iftestsaretobedeployedinareaswheretemperaturesrarelyriseabove30C,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)
http://www.wpro.who.int/sites/rdthttp://www.finddiagnostics.org/programs/malaria/find_activities/product_testing/malaria-rdt-product-testing/index.jsphttp://www.finddiagnostics.org/programs/malaria/find_activities/product_testing/malaria-rdt-product-testing/index.jsphttp://www.finddiagnostics.org/programs/malaria/find_activities/product_testing/malaria-rdt-product-testing/index.jsp -
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) 3
1.4. summary of outcomesThislaboratory-basedevaluationprovidesacomparativemeasureofRDTperformanceinastandardizedwaytodistinguishbetweenwellandpoorlyperformingteststoinformprocurementdecisionsofmalariacontrolprogrammesandguideUNprocurementpolicy.
Overall,animprovementwasnotedintheperformanceofproductsre-submittedtoRound3(TableS3),indicatingproductimprovementbythemanufacturers.Furthermore,theproportionoftestsachievingaPDS(>75%)at200parasites/lishigherthanthatseeninpreviousreports.
SeveralRDTsfromthethreeroundsoftestingdemonstratedconsistentdetectionofmalariaatlowparasitedensities(200parasites/l),havelowfalsepositiverates,arestableattropicaltemperatures,arerelativelyeasytouse,andcandetectP. falciparum,P. vivaxinfections,orboth.
Performancebetweenproductsvariedwidelyatlowparasitedensity(200parasites/l);however,themajorityofproductsshowedahighlevelofdetectionat2000or5000parasites/l.
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-makingprocessandcomprehensiveguidanceonseveralaspectsofprocurementcanbefoundinGoodPracticesforselectingandprocuringrapiddiagnostictestsformalaria.11
10 TheWHO-FINDMalariaRDTEvaluationProgrammeprovideslot-testingcapacityinanumberofregionallaboratoriesfreeofcharge,[email protected]@finddiagnostics.org.
11 GoodPracticesforselectingandprocuringrapiddiagnostictestsformalaria,Geneva,WorldHealthOrganization,2011ISBN9789241501125
mailto:Malaria_rdt%40who.int?subject=mailto:info%40finddiagnostics.org?subject= -
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/l) 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)
-
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) 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/l) 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
/l)
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/
l20
00 o
r 50
00
para
sites
/l
200
pa
rasit
es/
l20
00 o
r 50
00
para
sites
/l
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
odiu
m sp
p.
Infe
ctio
ni
Pf o
nly
Adva
nced
Qua
lity
One
Ste
p M
alar
ia P
.f Te
stj
ITP1
1002
TC40
InTe
c Pr
oduc
ts, I
nc.
93.9
N/A
100.
0N
/AN
/A40
.0N
/A35
.738
.50.
13
Adva
nced
Qua
lity
Mal
aria
(p.f)
POC
TIT
P110
02TC
1In
Tec
Prod
ucts
, Inc
.57
.0N
/A10
0.0
N/A
N/A
12.5
N/A
17.5
16.1
0.0
1Ad
vant
age
P.f.
Mal
aria
Car
dIR
0160
25J.
Mitr
a &
Co.
Pvt
. Ltd
.97
.5N
/A10
0.0
N/A
N/A
1.3
N/A
2.5
0.0
0.0
1BI
ONOT
E M
ALAR
IA P
.f. A
g Ra
pid
Test
Kit
RG19
-11
Bion
ote,
Inc.
85.9
N/A
99.0
N/A
N/A
0.0
N/A
1.4
2.0
0.1
3Ca
reSt
art
Mal
aria
HRP
2 (P
f)G
0141
Acce
ss B
io, I
nc.
98.7
N/A
98.7
N/A
N/A
5.0
N/A
7.5
2.4
0.0
1Ca
reSt
art
Mal
aria
HRP
2/pL
DH P
f tes
tG
0181
Acce
ss B
io, I
nc.
98.0
N/A
100.
0N
/AN
/A0.
6N
/A1.
33.
00.
02
Clea
rvie
w
Mal
aria
P.f.
j VB
01Vi
sion
Bio
tech
(Pty
) Ltd
83.8
N/A
100.
0N
/AN
/A0.
0N
/A0.
00.
00.
03
Core
M
alar
ia P
f M
AL-1
9002
0Co
re D
iagn
ostic
s97
.0N
/A10
0.0
N/A
N/A
0.0
N/A
0.0
1.0
(198
)0.
33
diag
nost
icks
- M
alar
ia (P
f) Ca
sset
te
KMFC
6001
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
59.0
N/A
99.0
N/A
N/A
1.9
N/A
2.6
(77)
7.0
0.9
2di
agno
stic
ks-
Mal
aria
(Pf)
Dips
tick
KM
FD60
07SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s80
.0N
/A99
.0N
/AN
/A2.
5N
/A3.
82.
00.
02
Firs
t Res
pons
e M
alar
ia A
g H
RP2
I13F
RC30
Prem
ier M
edic
al C
orpo
ratio
n Lt
d.10
0.0
N/A
100.
0N
/AN
/A0.
0N
/A0.
03.
00.
01
Firs
tSig
n
Mal
aria
Pf C
ard
Test
--U
nim
ed In
tern
atio
nal,
Inc.
31.7
N/A
86.1
N/A
N/A
12.5
N/A
15.0
2.4
(166
)0.
01
Hex
agon
Mal
aria
5805
1H
uman
Gm
bH39
.2N
/A94
.9N
/AN
/A7.
9 (7
6)N
/A2.
54.
2 (1
67)
1.2
1H
iSen
s M
alar
ia A
g Pf
HRP
2 Ca
rd
HR3
023
HBI
Co.
, Ltd
.87
.0N
/A10
0.0
N/A
N/A
0.0
N/A
0.0
1.0
0.1
2IC
T Di
agno
stic
s M
alar
ia P
.f.j
ML0
1IC
T Di
agno
stic
s86
.9N
/A98
.0N
/AN
/A0.
0N
/A0.
00.
00.
03
IMM
UN
OQU
ICK
CON
TACT
falc
ipar
um
0519
K25
Bios
ynex
81.8
N/A
100.
0N
/AN
/A3.
6 (1
39)
N/A
1.4
4.0
(199
)0.
33
Imm
unoq
uick
Mal
aria
Fal
cipa
rum
0502
_K25
Bios
ynex
91.1
N/A
100.
0N
/AN
/A0.
0N
/A0.
00.
60.
01
Mal
aria
Pla
smod
ium
falc
ipar
um R
apid
test
Dev
ice
(Who
le b
lood
)IM
A-40
2AC
ON L
abor
ator
ies,
Inc.
92.4
N/A
100.
0N
/AN
/A0.
0N
/A0.
00.
00.
01
Nan
oSig
n M
alar
ia P
f Ag
RMAF
10Bi
olan
d, L
td84
.9N
/A10
0.0
N/A
N/A
0.0
N/A
0.0
0.0
0.3
3On
e St
ep M
alar
ia P
.F T
est (
cass
ette
)j 52
2352
Blue
Cro
ss B
io-M
edica
l (Be
ijing)
Co.
, Ltd
.67
.7N
/A97
.0N
/AN
/A0.
0N
/A2.
91.
00.
23
One
Step
Mal
aria
P.f
Test
j W
37-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.60
.6N
/A98
.0N
/AN
/A0.
7 (1
39)
N/A
0.0
0.0
0.2
3On
Sigh
t -
Mal
aria
Pf T
est
511-
25-D
BAm
geni
x In
tern
atio
nal,
Inc.
74.0
N/A
99.0
N/A
N/A
8.1
N/A
2.5
11.0
0.0
2On
Site
Pf A
g Ra
pid
Test
j R0
114C
CTK
Biot
ech,
Inc.
85.9
N/A
100.
0N
/AN
/A0.
7N
/A0.
03.
50.
03
Para
chec
k P
f Dev
ice-
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia V
er. 3
j 30
3010
25Or
chid
Bio
med
ical
Sys
tem
s96
.0N
/A99
.0N
/AN
/A0.
0 (1
38)
N/A
1.5
(68)
1.5
0.9
3Pa
rach
eck
Pf D
ipst
ick-
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia V
er. 3
j 30
3020
25Or
chid
Bio
med
ical
Sys
tem
s89
.9N
/A98
.0N
/AN
/A0.
0N
/A1.
40.
50.
03
Para
HIT
-
f (De
vice
)j 55
IC10
2-50
Span
Dia
gnos
tics
Ltd.
84.9
N/A
100.
0N
/AN
/A0.
0N
/A0.
00.
00.
03
Para
HIT
-f
(Dip
stic
k)j
55IC
101-
50Sp
an D
iagn
ostic
s Lt
d.80
.8N
/A99
.0N
/AN
/A0.
0N
/A1.
42.
50.
03
SD B
IOLI
NE
Mal
aria
Ag
P.f.
(HRP
2/pL
DH)k
05FK
90St
anda
rd D
iagn
ostic
s In
c.87
.9N
/A10
0.0
N/A
N/A
0.0
N/A
0.0
2.0
0.0
3SD
BIO
LIN
E M
alar
ia A
g Pf
05FK
50St
anda
rd D
iagn
ostic
s, In
c.97
.5N
/A98
.7N
/AN
/A0.
0N
/A0.
02.
40.
01
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
.69
.70.
099
.062
.90.
00.
00.
00.
00.
00.
03
Adva
ntag
e M
al C
ard
IR22
1025
J. M
itra
& C
o. P
vt. L
td.
62.0
100.
010
0.0
100.
02.
50.
00.
00.
04.
20.
01
Bina
x N
ow M
alar
ia T
est
IN66
0050
Inve
rnes
s M
edic
al In
nova
tions
, Inc
.91
.110
.010
0.0
85.0
0.3
3.8
(79)
0.0
(157
)5.
00.
00.
31
BION
OTE
MAL
ARIA
P.f.
& P
an A
g Ra
pid
Test
Kit
RG19
-08
Bion
ote,
Inc.
93.9
88.6
99.0
100.
00.
00.
00.
00.
03.
0 (1
99)
0.1
3Ca
reSt
art
Mal
aria
/Pre
gnan
cy C
ombo
(pLD
H/H
RP2/
HCG
) G
O221
Acce
ss B
io, I
nc.
83.8
94.3
100.
097
.12.
31.
4 (1
39)
0.0
(194
)1.
40.
00.
23
Care
Star
t M
alar
ia H
RP2/
pLDH
(Pf/
PAN
) COM
BOG
0131
Acce
ss B
io, I
nc.
97.5
90.0
100.
095
.00.
31.
30.
02.
53.
00.
01
Care
Star
t M
alar
ia p
LDH
3 L
ine
Test
G
O121
Acce
ss B
io, I
nc.
88.9
91.4
100.
010
0.0
1.3
0.7
6.1
0.0
0.5
0.0
3Ca
reSt
art
Mal
aria
Scr
een
GO2
31Ac
cess
Bio
, Inc
.86
.988
.610
0.0
100.
01.
82.
10.
00.
02.
5 (1
99)
0.1
3
-
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) 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 (%
)To
tal f
alse
pos
itive
ra
tesb
(%)
Inva
lid
rate
(%)
(n=1
204)
Roun
d
200
pa
rasit
es/
l20
00 o
r 50
00
para
sites
/l
200
pa
rasit
es/
l20
00 o
r 50
00
para
sites
/l
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
odiu
m sp
p.
Infe
ctio
ni
Clea
rvie
w
Mal
aria
Com
boj
VB11
Visi
on B
iote
ch (P
ty) L
td82
.85.
710
0.0
91.4
0.0
5.7
0.5
5.7
3.5
0.0
3Cl
earv
iew
M
alar
ia D
ual T
est D
evic
ej
VB20
Visi
on B
iote
ch (P
ty) L
td69
.748
.698
.094
.30.
00.
7 (1
39)
0.0
1.4
1.0
0.2
3di
agno
stic
ks M
ALAR
IA (P
an/P
f) Ca
sset
te
MPN
FWBC
1007
.4SS
A Di
agno
stic
s &
Bio
tech
Sys
tem
s98
.051
.410
0.0
97.1
0.0
(394
)0.
00.
00.
0 (6
9)2.
50.
33
Firs
t Res
pons
e M
alar
ia p
LDH
/HRP
2 Co
mbo
Tes
tj I1
6FRC
30Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
84.0
75.0
100.
010
0.0
0.0
0.0
0.0
0.0
0.0
0.0
2Fi
rstS
ign
- P
araV
iew
(Pan
+Pf)
Mal
aria
Tes
t21
01 C
B-25
Uni
med
Inte
rnat
iona
l Inc
.85
.080
.099
.010
0.0
0.0
0.6
(159
)0.
5 (1
99)
0.0
25.5
0.2
2H
exag
on M
alar
ia C
ombi
5802
4H
uman
Gm
bH46
.80.
097
.550
.00.
00.
0 (7
9)0.
0 (1
57)
2.6
(38)
3.0
(167
)0.
71
HiS
ens
Mal
aria
Ag
P.f/
P.v
Card
H
R282
3H
BI C
o., L
td.
20.0
15.0
94.0
100.
00.
00.
00.
00.
00.
00.
02
HiS
ens
Mal
aria
Ag
Pf/P
v (H
RP2/
pLDH
) Car
dH
R292
3H
BI C
o., L
td.
84.0
75.0
99.0
100.
00.
00.
00.
00.
00.
50.
02
ICT
Diag
nost
ics
Mal
aria
Com
boj
ML0
2IC
T Di
agno
stic
s84
.98.
698
.091
.40.
03.
60.
05.
72.
50.
03
ICT
Diag
nost
ics
Mal
aria
Dua
l M
L03
ICT
Diag
nost
ics
78.8
60.0
99.0
97.1
0.5
(394
)0.
00.
01.
40.
5 (1
99)
0.3
3IM
MU
NOQ
UIC
K CO
NTA
CT M
ALAR
IA +
4 05
25K2
5Bi
osyn
ex75
.817
.198
.094
.31.
8 (3
95)
5.1
(138
)0.
00.
02.
00.
33
Imm
unoq
uick
Mal
aria
+4
0506
_K25
Bios
ynex
93.7
30.0
98.7
100.
00.
0 (3
14)
0.0
0.0
(157
)0.
00.
60.
01
Mal
aria
P.F
/Viv
ax17
211O
P-25
Diag
nost
ics
Auto
mat
ion/
Cort
ez
Diag
nost
ics,
Inc.
73.6
(53)
0.0
(15)
94.9
(39)
30.8
(13)
1.0
(97)
0.0
(30)
2.1
(48)
0.0
(18)
1.6
(64)
67.5
1
Mal
aria
Pan
Tes
t M
AL-W
23N-
001
Dim
a G
esel
lscha
ft f
r Dia
gnos
tika m
bH54
.60.
097
.048
.62.
815
.70.
017
.144
.00.
03
Mal
aria
pf (
HRP
II) /
(PAN
-pLD
H) A
ntig
en D
etec
tion
Test
Dev
icej
M
FV-1
24R
AZOG
, Inc
.95
.00.
010
0.0
94.3
0.0
(395
)7.
98.
10.
05.
5 (1
99)
0.3
3M
alar
ia p
f (pL
DH) /
PAN
-pLD
H T
est D
evic
e M
FV-1
24AZ
OG, I
nc.
2.0
5.7
70.7
97.1
0.0
(394
)0.
0 (1
39)
0.0
0.0
0.0
(198
)0.
43
Mal
asca
n D
evic
e -
Rapi
d te
st fo
r Mal
aria
Pf/
Panj
50
4020
25Ze
phyr
Bio
med
ical
Sys
tem
s82
.857
.197
.010
0.0
1.0
(392
)0.
7 (1
36)
1.0
(194
)0.
0 (6
8)1.
0 (1
95)
1.9
3N
anoS
ign
Mal
aria
Pf/
Pan
Ag
RMAP
10Bi
olan
d, L
td77
.80.
010
0.0
91.4
0.0
2.9
0.0
(197
)2.
90.
50.
03
Nan
oSig
n M
alar
ia P
f/Pv
Ag
-RM
AD10
Biol
and,
Ltd
6.1
8.6
89.9
100.
00.
50.
0 (1
39)
0.0
0.0
0.0
0.1
3On
e St
ep M
alar
ia A
ntig
en S
trip
820-
1IN
D Di
agno
stic
Inc.
1.3
0.0
67.1
60.0
2.2
3.8
1.9
0.0
1.8
(167
)0.
01
One
Step
Mal
aria
P.f/
Pan
Test
j W
56-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.37
.485
.795
.010
0.0
8.4
(383
)0.
0 (1
37)
0.0
(194
)0.
0 (6
8)4.
1 (1
95)
2.4
3On
Sigh
t
Par
aQui
ck (P
an, P
f) Te
st53
6-25
DBAm
geni
x In
tern
atio
nal,
Inc.
59.5
50.0
100.
010
0.0
0.0
1.3
0.0
0.0
0.0
0.0
1On
Site
Pf/
Pan
Mal
aria
Ag
Rapi
d Te
st
R011
3CCT
K Bi
otec
h, In
c.83
.885
.710
0.0
100.
01.
30.
00.
00.
027
.50.
03
OptiM
AL-I
T 71
0024
Diam
ed -
A D
ivis
ion
of B
io-R
ad50
.597
.196
.068
.61.
50.
00.
520
.3 (6
9)2.
0 (1
98)
0.5
3Pa
raH
IT
tota
l (di
pstic
k)55
IC20
1-10
Span
Dia
gnos
tics
Ltd
64.0
10.0
99.0
97.5
0.0
0.0
0.0
0.0
7.0
0.0
2Pa
rahi
t-To
tal D
evic
e Ra
pid
test
for P
. fal
cipa
rum
and
Pan
m
alar
ial s
peci
es.
2598
9Sp
an D
iagn
ostic
s Lt
d.35
.40.
093
.750
.00.
0 (3
15)
0.0
0.0
2.5
0.0
0.2
1
Para
scre
en
Dev
ice
- Ra
pid
test
for M
alar
ia P
an/P
f50
3100
25Ze
phyr
Bio
med
ical
Sys
tem
s89
.945
.797
.088
.61.
0 (3
94)
2.1
0.0
(197
)7.
13.
5 (1
99)
0.4
3Qu
icks
tick
Mal
aria
Ant
igen
Tes
t--
Inno
vate
k M
edic
al In
c.1.
30.
067
.160
.02.
23.
81.
90.
01.
8 (1
67)
0.0
1SD
BIO
LIN
E M
alar
ia A
g P.
f/Pa
nj
05FK
60St
anda
rd D
iagn
ostic
s In
c.92
.997
.199
.010
0.0
0.5
(394
)0.
00.
50.
03.
5 (1
99)
0.3
3SD
BIO
LIN
E M
alar
ia A
gj
05FK
40St
anda
rd D
iagn
ostic
s In
c.16
.297
.193
.910
0.0
0.8
0.0
0.0
0.0
0.0
0.0
3Su
rest
ep
Eas
y M
alar
ia P
f/Pa
n Ra
pid
Test
Dev
ice
IMA-
T402
ACON
Bio
tech
(Han
gzho
u) C
o. L
td.
83.8
0.0
100.
010
0.0
0.0
0.0
0.0
0.0
1.0
0.0
3Pf
and
Pv
Adva
nced
Qua
lity
One
Ste
p M
alar
ia P
.f/P.
v Tr
i-Li
ne T
est
ITP1
1003
TC4
0In
Tec
Prod
ucts
, Inc
.86
.90.
010
0.0
5.7
15.7
(395
)5.
78.
1 (1
97)
4.3
18.5
0.2
3Ad
vant
age
Mal
aria
Car
d IR
2110
25J.
Mitr
a &
Co.
Pvt
. Ltd
.77
.831
.499
.010
0.0
0.5
0.7
0.0
0.0
0.0
0.0
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.92
.997
.198
.010
0.0
0.3
0.7
1.5
(197
)0.
04.
00.
03
Care
Star
t M
alar
ia H
RP2/
PLDH
(Pf/
Pv) C
OMBO
G01
61Ac
cess
Bio
, Inc
.90
.090
.010
0.0
100.
00.
30.
60.
00.
00.
50.
02
Care
Star
t M
alar
ia H
RP2/
PLDH
(Pf/
VOM
) COM
BOG
0171
Acce
ss B
io, I
nc.
89.0
80.0
100.
010
0.0
1.3
0.0
0.5
0.0
0.5
0.0
2
-
Malaria rapid diagnostic test perforMance results of WHo product testing of malaria rdts: round 3 (2010-2011)8
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/
l20
00 o
r 50
00
para
sites
/l
200
pa
rasit
es/
l20
00 o
r 50
00
para
sites
/l
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
odiu
m sp
p.
Infe
ctio
ni
Core
M
alar
ia P
v/Pf
MAL
-190
022
Core
Dia
gnos
tics
98.0
60.0
100.
097
.10.
30.
00.
00.
04.
00.
13
diag
nost
icks
- M
alar
ia (P
v/Pf
) Cas
sett
eKM
VFC6
002
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
91.0
45.0
99.0
100.
00.
3 (3
99)
0.6
0.0
0.0
2.0
0.1
2Fa
lciv
ax R
apid
Tes
t for
Mal
aria
Pv/
Pf (d
evic
e)50
3000
25Ze
phyr
Bio
med
ical
s92
.045
.010
0.0
100.
00.
01.
30.
00.
0 (7
9)4.
50.
22
Firs
tSig
n
Par
aVie
w-2
(Pv
+ Pf
) Car
d Te
st21
02CB
-25
Uni
med
Inte
rnat
iona
l, In
c.48
.10.
098
.785
.01.
03.
8N
/A5.
00.
0 (1
67)
0.0
1M
alar
ia p
f (H
RP II
) / p
v (p
LDH
) Ant
igen
Det
ectio
n Te
st D
evic
e M
FV-1
24V
AZOG
, Inc
.79
.80.
010
0.0
20.0
0.0
1.4
0.0
0.0
0.0
(199
)0.
13
Mal
eris
can
Mal
aria
Pf/
Pv
MAT
-50
Bhat
Bio
-Tec
h In
dia
(P) L
td52
.00.
097
.060
.01.
8 (3
99)
2.5
32.5
2.5
(79)
1.5
(199
)0.
42
OnSi
ght
- P
araQ
uick
-2 (P
v,Pf)
Mal
aria
Tes
t53
7-25
-DB
Amge
nix
Inte
rnat
iona
l, In
c.92
.037
.510
0.0
100.
00.
51.
90.
00.
03.
50.
12
OnSi
te M
alar
ia P
f/Pv
Ag
Rapi
d Te
stj
R011
2CCT
K Bi
otec
h, In
c.84
.997
.110
0.0
100.
05.
30.
06.
10.
028
.00.
03
SD B
IOLI
NE
Mal
aria
Ag
Pf/P
v05
FK80
Stan
dard
Dia
gnos
tics,
Inc.
96.0
95.0
100.
010
0.0
0.0
0.0
(159
)0.
0 (1
99)
0.0
3.5
0.2
2Pf
, Pv
and
Pan
Core
M
alar
ia P
an/P
v/Pf
M
AL-1
9002
6Co
re D
iagn
ostic
s92
.911
.499
.094
.30.
3 (3
91)
0.0
(137
)0.
0 (1
97)
1.4
3.5
(198
)1.
03
diag
nost
icks
MAL
ARIA
(Pan
/Pv/
Pf) C
asse
tte
MPN
VFC1
007.5
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
93.9
11.4
99.0
94.3
0.0
(389
)0.
0 (1
39)
0.0
(196
)2.
9 (6
9)4.
0 (1
99)
1.1
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
.89
.045
.010
0.0
100.
00.
0 (3
99)
2.5
0.0
0.0
24.5
0.1
2Pa
ram
ax-3
Rap
id T
est f
or M
alar
ia P
an/P
v/Pf
(dev
ice)
5032
0025
Zeph
yr B
iom
edic
als
93.0
45.0
100.
010
0.0
0.0
(396
)0.
0 (1
59)
0.0
(199
)0.
037
.0 (1
98)
0.7
2Pa
n on
lyAd
vant
age
Pan
Mal
aria
Car
dIR
0130
25J.
Mitr
a &
Co.
Pvt
. Ltd
.72
.210
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
1.8
0.0
1Ca
reSt
art
Mal
aria
pLD
H (P
AN)
G01
11Ac
cess
Bio
, Inc
.92
.410
0.0
100.
010
0.0
N/A
N/A
N/A
N/A
6.6
0.0
1Cl
earv
iew
M
alar
ia p
LDH
j 70
8840
25Or
geni
cs L
td.
81.8
85.7
99.0
100.
0N
/AN
/AN
/AN
/A13
.50.
53
diag
nost
icks
MAL
ARIA
(Pan
) Cas
sett
e M
PNW
BC10
07.3
SSA
Diag
nost
ics
& B
iote
ch S
yste
ms
16.2
54.3
92.9
100.
0N
/AN
/AN
/AN
/A0.
00.
33
Firs
t Res
pons
e M
alar
ia A
g pL
DHI1
2FRC
30Pr
emie
r Med
ical
Cor
pora
tion
Ltd.
31.0
92.5
98.0
100.
0N
/AN
/AN
/AN
/A0.
00.
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.
25.0
82.5
87.0
100.
0N
/AN
/AN
/AN
/A2.
50.
22
OnSi
ght
- P
anSc
reen
(Pan
) Mal
aria
Tes
t53
9-25
-DB
Amge
nix
Inte
rnat
iona
l, In
c.22
.077
.596
.010
0.0
N/A
N/A
N/A
N/A
2.5
0.2
2Pa
raba
nk
Dev
ice
- Ra
pid
test
for M
alar
ia P
anj
5030
1025
Zeph
yr B
iom
edic
al S
yste
ms
17.2
62.9
90.9
100.
0N
/AN
/AN
/AN
/A0.
50.
23
Pv o
nly
SD B
IOLI
NE
Mal
aria
Ag
Pv05
FK70
Stan
dard
Dia
gnos
tics,
Inc.
N/A
92.5
N/A
100.
00.
3N
/A1.
0N
/A1.
00.
02
Pf: P
lasm
odiu
m fa
lcip
arum
Pv
: Pla
smod
ium
viv
ax
pan:
Pla
smod
ium
spec
ies
a A
sam
ple
is c
onsi
dere
d de
tect
ed o
nly
if al
l RDT
s fr
om b
oth
lots
read
by
the
first
te
chni
cian
, at m
inim
um s
peci
fied
read
ing
time,
are
pos
itive
b Th
e to
tal n
umbe
r of t
imes
a p
ositi
ve re
sult
for m
alar
ia w
as g
ener
ated
whe
n it
shou
ld n
ot h
ave
been
c
Roun
d 1,
n=7
9; R
ound
2, n
=100
; Rou
nd 3
, n=9
9d
Roun
d 1,
n=2
0; R
ound
2, n
=40;
Rou
nd 3
, n=3
5e
For c
ombi
natio
n te
sts,
Pan
or P
v lin
e, o
nly,
posi
tive
indi
cate
s a
fals
e po
sitiv
e P.
falc
ipar
um in
fect
ion
(Rou
nd 1
n=3
16; R
ound
2, n
=400
; Rou
nd 3
, n=3
96)
f Pf
line
pos
itive
indi
cate
s a
fals
e po
sitiv
e P.
falc
ipar
um in
fect
ion
(Rou
nd 1
, n=8
0;
Roun
d 2,
n=1
60; R
ound
3, n
=140
)g
For c
ombi
natio
n te
sts,
Pan
or P
v lin
e, o
nly,
posi
tive
indi
cate
s a
fals
e po
sitiv
e P.
falc
ipar
um in
fect
ion
(Rou
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
/l;
97%
at 2
000p
/l)
and
pf-H
RP2
(87.
9% a
t 200
p/l
; 100
% a
t 200
0p/
l)
Dete
ctio
n ra
te (%
)9
585
-94
50-8
4<
50
Fals
e po
sitiv
e ra
te (%
)1
0
Inva
lid ra
te (%
)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/
l).
Posi
tivi
ty r
ate
at b
asel
ine,
and
aft
er 6
0 da
ys in
cuba
tion
at 3
5C
and
45C
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/
l20
00 p
aras
ites/
l20
0 pa
rasit
es/
l20
00 p
aras
ites/
l
Base
line
35C
45C
Base
line
35C
45C
Base
line
35C
45C
Base
line
35C
45C
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
yM
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
5223
52Bl
ue C
ross
Bio
-Med
ical (
Beiji
ng) C
o., L
td.
63.3
0.0
0.0
100.
010
0.0
100.
0N
/AN
/AN
/AN
/AN
/AN
/A3
One
Step
Mal
aria
P.f
Test
a W
37-C
Gua
ngzh
ou W
ondf
o Bi
otec
h Co
. Ltd
.10
0.0
93.3
90.0
100.
010
0.0
100.
0N
/AN
/AN
/AN
/AN
/AN
/A3
OnSi
ght
- M
alar
ia P
f Tes
t51
1-25
-DB
Amge
nix
Inte
rnat
iona
l, In
c.10
0.0
95.0
90.0
100.
010
0.0
65.0
N/A
N/A
N/A
N/A
N/A
N/A
2On
Site
Pf A
g Ra
pid
Test
a R0
114C
CTK
Biot
ech,
Inc.
96.7
100.
010
0.0
100.
010
0.0
100.
0N
/AN
/AN
/AN
/AN
/AN
/A3
Para
chec
k P
f Dev
ice-
Rap
id te
st fo
r P. f
alci
paru
m M
alar
ia V
er. 3
a 30
3010
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
chec
k P
f Dip
stic
k- R
apid
test
for P
. fal
cipa
rum
Mal
aria
Ver
. 3a
3030
2025
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
raH
IT
- f (
Devi
ce)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.
0N
/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