During2004,atotalof124batchesofHIVantibodyELISAsfromdomesticandoverseasmanufacturers,comprisingapproximately60milliontests,weretestedforqualityandreleasedforscreeningbloodinChina.Theinter-andintra-batchvariation,specificity,andsensitivitywereevaluatedusingalaboratorypanelandclinicalsamples.Theinter-batchvariationwaslessthan15%andonly2of12assayshadintra-batchvariationoflessthan20%for4dilutionsofacontrolspecimen.257samplesconfirmedpositiveforHIVantibodyand4826negativesamplesfromdifferentregionsinChinawereusedtoevaluatethesensitivityandspecificityoftheassays.Theresultsshowedthatthesensitivityisintherangefrom93.7%to100%forassayssampleddirectlyfromthemanufacturers,and91.4%-99.6%forthoseretrievedfromtheconsumers;thespecificitywasintherangefrom97.88%to99.97%.ThetestingenvironmentmayvaryindifferentregionsofChina.Therefore,manufacturersshouldproviderobustassaystosatisfytherequirementsoftheseperseenvironments,andespeciallyreducetheintra-assayvariationandimprovethestabilityofthekits.
