学科分类
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1 个结果
  • 简介: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,manufacturersshouldproviderobustassaystosatisfytherequirementsofthesediverseenvironments,andespeciallyreducetheintra-assayvariationandimprovethestabilityofthekits.

  • 标签: 质量控制 免疫缺陷病毒抗体 血液 中国