一种新型肠道病毒核酸检测试剂的初步评价  

Preliminary evaluation of a new reagent of enterovirus nucleic acid detection

作　　者：黄长武[1] 单幼兰[2] 唐彦[3] 谭俊杰[4] 张晓清[5] 

机构地区：[1]重庆医科大学附属第二医院检验科,400010 [2]重庆医科大学附属第二医院传染病实验室,400010 [3]重庆市中医骨科医院检验科,400012 [4]重庆医科大学附属儿童医院分子生物实验室,400014 [5]重庆医科大学检验医学院,400016

出　　处：《检验医学与临床》2015年第7期907-909,共3页Laboratory Medicine and Clinic

基　　金：重庆市渝中区科技三费资助科技计划项目(20130143)

摘　　要：目的评价新型磁珠法肠道病毒核酸检测试剂(以下简称"磁珠法试剂")的灵敏度和精密度。方法对204份标本分别用磁珠法试剂和Trizol法试剂进行肠道病毒RNA定性检测,评价其一致性和等效性,并比较两种试剂的灵敏度和精密度。结果磁珠法试剂与Trizol法试剂的阳性符合率为97.58%,阴性符合率为100.00%,总符合率为98.53%,Kappa值为0.969 4。磁珠法试剂的灵敏度高于Trizol法试剂。对两个中、低浓度标本各重复检测10次,磁珠法试剂的变异系数(CV)为0.84%、0.96%,Trizol法试剂为2.01%、1.43%。结论新型磁珠法试剂盒与Trizol法试剂盒具有较高的一致性,其灵敏度、精密度优于Trizol法试剂盒,可以用于临床肠道病毒核酸检测。Objective To evaluate the quality of the new beads method reagent for enterovirus detection（hereinafter referred to ＂ beads method＂）and the role of inter control system.Methods A total of 204 clinical specimens were qualitatively detected by beads method and Trizol assay.The consistency and equivalence of two assays were evaluated.The sensitivity and precision of two assays were compared.Results Comparing beads method with Trizol assay,the positive consistency was 97.58%,the negative consistency was 100.00%,the total consistency was98.53%,and Kappavalue was 0.969 4.One sample with medium concentration and one sample with high concentration were respectively detected 10 times for the calculation of precision.The CVs of beads method were 0.84%and 0.96%,for the medium and high concentration sample respectively,while those of Trizol assay were 2.01% and1.43% respectively.Conclusion The new beads method kit has high consistency with Trizol method kit,which shows better sensitivity and precision than Trizol method and can be used for enterovirus detection in clinical.

关 键 词：肠道病毒 磁珠法 TRIZOL法 内标 

分 类 号：R542.210.4[医药卫生—心血管疾病]