Quality Control and Performance of HIV Rapid Tests in a Microbicide Clinical Trial in Rural KwaZulu-Natal 英文参考文献.docVIP

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Quality Control and Performance of HIV Rapid Tests in a Microbicide Clinical Trial in Rural KwaZulu-Natal 英文参考文献.doc

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Quality Control and Performance of HIV Rapid Tests in a Microbicide Clinical Trial in Rural KwaZulu-Natal 英文参考文献

QualityControlandPerformanceofHIVRapidTestsina MicrobicideClinicalTrialinRuralKwaZulu-Natal NinavonKnorring1,2*,MitzyGafos1,MotseiRamokonupi1,UteJentsch3,andtheMDPTeam 1AfricaCentreforHealthandPopulationStudies,UniversityofKwaZulu-Natal,Mtubatuba,SouthAfrica,2WitsReproductiveHealthandHIVInstitute,Johannesburg, SouthAfrica,3ContractLaboratoryServices,UniversityoftheWitwatersrandHealthConsortium,Johannesburg,SouthAfrica Abstract Background:Qualitycontrol(QC)andevaluationofHIVrapidtestproceduresareanimportantaspectofHIVprevention trials.WedescribeQCandperformanceoftworapidtests,DetermineTMandUni-GoldTMusedinamicrobicideclinicaltrialin ruralKwaZulu-Natal,SouthAfrica. Methods/Results: Internal QC of both HIV rapid tests was conducted at the trial site using a Uni-Gold control kit (Uni- GoldTMRecombigenHHIV).Bothassaysproducedtheexpectedresultsforatotalof4637QCtests.Studyparticipantswere testedforHIVatscreeningand,ifenrolled,atregulartimepointsthroughoutthestudy.Positiveordiscordantresultswere confirmed by a double HIV immunoassay testing strategy at a local laboratory. Overall, 15292 HIV rapid test were performed. Sensitivity and specificity of Determine was 98.95% (95% CI: 97.72–99.61) and 99.83% (95% CI: 99.70–99.91) respectively[positivepredictivevalue(PPV)97.91%(95%CI:96.38–98.92)],forUni-Golditwas99.30%(95%CI:98.21–99.81) and99.96%(95%CI:99.88–99.99)respectively[PPV99.47%(95%CI:98.46–99.89)]. Conclusions:TheresultssuggestthataUni-GoldcontrolkitcanbeusedforinternalQCofbothUni-GoldandtheHIV-1 componentoftheDeterminerapidtests.Bothrapidtestsperformedproficientlyinthetrialpopulation. Citation:vonKnorringN,GafosM,RamokonupiM,JentschU,theMDPTeam(2012)QualityControlandPerformanceofHIVRapidTestsinaMicrobicideClinical TrialinRuralKwaZulu-Natal.PLoSONE7(1):e30728.doi:10.1371/journal.pone.0030728 Editor:PhilipJ.Norris,BloodSystemsResearchInstitute,UnitedStatesofAmerica ReceivedJune28,2011;AcceptedDecember27,2011;PublishedJanuary30,2012 Copyright:?2012vonKnorringetal.Thisisan