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％，K ap pa值为 0．9694。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(here‐inafter 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 was 98 .53% ,and K ap pa value was 0 .969 4 .One sample with medium concentration and one sample with high concen‐tration 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% and 1 .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 .
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