中国卫生检验杂志2013年6月第23卷第6期ChineseJournaloFHealthLaboratoryTechnology，Jun2013;Vol23No61627【产品评价】国产核酸检测试剂盒在献血者血液筛查中的应用性能评估张宁1，张怀勇2，王芳1(1．辽宁省血液中心，沈阳110044;2．上海浩源生物科技有限公司，上海201703)［摘要］目的:了解国产核酸检测试剂在血液筛查中应用的稳定性及准确性，为NAT技术用于常规血液筛查提供理论基础和实验依据。方法:通过将WHO－HBV/WHO－HCV/WHO－HiV国际标准品稀释至不同浓度，应用国产核酸检测试剂盒进行核酸检测并对每个稀释度重复检测6次;对卫生部临检中心提供室内质控品B01/C01/HO4－a连续开展60次核酸检测。结果:(1)WHO－HBV每个稀释后标准液检出率均为100%;WHO－HCV稀释后标准液(20iU/ml)检出率为66．7%，标准液(10iU/ml)检出率为33．3%，其余检出率都为100%;WHO－HiV稀释后标准液(50iU/ml)检出率为83．3%，标准液(10iU/ml)检出率为83．3%，其余检出率都为100%;(2)精密性测试中B01检测结果39．02，s=0．81，cv=2．07%;C01检测结果36．6，s=0．92，cv=2．52%;H04－a检测结果32．4，s=0．57，cv=1．75%。结论:国产核酸检测试剂在献血者血液筛查中的稳定性和准确性能够有效的保障临床用血安全。［关键词］核酸检测;灵敏度;血液筛查;精密度［中图分类号］Ｒ446．1［文献标识码］C［文章编号］1004－8685(2013)06－1626－03PerformanceevaluationofthedomesticnucleicaciddetectionKitinblooddonationscreeningZHANGNing1，ZHANGHuai－yong2，WANGFang1(1．LiaoningProvincialBloodCenter，Shenyang110044，China;2．ShanghaiHaoyuanBiotechCo．，Ltd．，Shang-hai201703，China)［Abstract］ObjectiveToevaluatethestabilityandaccuracyoFthedomesticnucleicaciddetectionkitinblooddonationscreening，providingthetheoreticalbasisandexperimentalevidenceFortheNATassayinregularbloodscreening．Methods:TheWHOinternationalstandardsubstanceForHBVDNA，HCVＲNAandHiVＲNAdilutedtovariousconcentrationsweretestedbythedomesticnucleicaciddetectionkit，andeachdilutionwasdetected6times．TheinternalQualityControlproductFromNCCL(B01/C01/H04－a)wasdetectedForcontinuous60times．Ｒesults:1．AmongthestandardsamplesFromdilutedWHO－HBV，thepositiveratewas100%;Amongthestand-ardsamplesFromdilutedWHO－HCV，thepositiveratesoFsampleswhichhadaconcentrationoF20iU/mland10iU/mlwere66．7%and33．3%respectively，whileotherswereall100%;AmongthestandardsamplesFromdilu-tedWHO－HiV，thepositiveratesoFsampleswhichhadaconcentrationoF50iU/mland10iU/mlwereboth83．3%，whileotherswereall100%．2．intheprecisiontest，itcanbeknown39．02，s=0．81，cv=2．07%FromtheexaminationresultoFB01，36．6，s=0．92，cv=2．52%FromtheexaminationresultoFC01，32．4，s=0．57，cv=1．75%Fromtheexam