Monitoring Temporal Changes in the Specificity of an Oral HIV Test A Novel Application for Use in Postmarketing Surveillance 英文参考文献.docVIP

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Monitoring Temporal Changes in the Specificity of an Oral HIV Test A Novel Application for Use in Postmarketing Surveillance 英文参考文献.doc

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Monitoring Temporal Changes in the Specificity of an Oral HIV Test A Novel Application for Use in Postmarketing Surveillance 英文参考文献

MonitoringTemporalChangesintheSpecificityofan OralHIVTest:ANovelApplicationforUsein PostmarketingSurveillance JosephR.Egger1*,KevinJ.Konty1,JessicaM.Borrelli2,JuliaCummiskey2,SusanBlank2,3 1BureauofEpidemiologyServices,NewYorkCityDepartmentofHealthandMentalHygiene,NewYork,NewYork,UnitedStatesofAmerica,2BureauofSTDPrevention andControl,NewYorkCity DepartmentofHealthandMentalHygiene,NewYork,NewYork,UnitedStatesofAmerica, 3DivisionofSTDPrevention,U.S.Centersfor DiseaseControlandPrevention,Atlanta,Georgia,UnitedStatesofAmerica Abstract Background: Postmarketing surveillance is routinely conducted to monitor performance of pharmaceuticals and testing devicesinthemarketplace.However,thesesurveillancemethodsareoftendoneretrospectivelyand,asaresult,arenot designedtodetectissueswithperformanceinreal-time. MethodsandFindings:UsingHIVantibodyscreeningtestdatafromNewYorkCitySTDclinics, wedevelopedaformal, statisticalmethodofprospectivelydetectingtemporalclustersofpoorperformanceofascreeningtest.From2005to2008, NewYorkCity,aswellasotherstates,observedunexpectedlyhighfalse-positive(FP)ratesinanoralfluid-basedrapidtest usedforscreeningHIV.WeattemptedtoformallyassesswhethertheperformanceofthisHIVscreeningteststatistically deviated from both local expectation and the manufacturer’s claim for the test. Results indicate that there were two significanttemporalclustersintheFPrateoftheoralHIVtest,bothofwhichexceededthemanufacturer’supperlimitofthe 95%CIfortheproduct.Furthermore,theFPrateofthetestvariedsignificantlybybothSTDclinicandtestlot,thoughnot bytestoperator. Conclusions: Continuous monitoring of surveillance data has the benefit of providing information regarding test performance,andifconductedinreal-time,itcanenableprogramstoexaminereasonsforpoortestperformanceinclose proximitytotheoccurrence.Techniquesusedinthisstudycouldbeavaluableadditionforpostmarketingsurveillanceof testperformanceandmaybecomeparticularlyimportantwiththeincreaseinrapidtestingmethods. Citat