探讨多厂家抗-HCV ELISA试剂检测结果不一致的原因.选用4个国产厂家和2个进口厂家试剂对175份样品进行抗-HCV检测,并对其中17份检测结果不一致的样品和1份6个厂家试剂检测均为弱阳性的样品用抗-HCV ELISA分片段试剂进行检测,用SPSS13.0软件对检测结果进行统计分析.结果显示,6个厂家试剂对175份标本的检测结果,同为阴性85份,同为阳性38份,有52份样品检测结果不一致.18份结果不一致的样本用分片段试剂测定的结果为:Ⅰ试剂的假阴性率为75.00%(9/12);Ⅱ试剂的假阴性率为25.00%(3/12);Ⅲ试剂的假阴性率为66.67%(8/12);Ⅳ试剂的假阴性率为33.33%(4/12);Ⅴ试剂的假阴性率为58.33%(7/12);Ⅵ试剂的假阴性率为33.33%(4/12).采用II+V的组合实验检测假阴性率为8.33%(1/12),有很明显的降低.结论:试剂盒包被抗原成份的差异可能是检测结果不一致的重要原因,选择包被抗原成份互补的试剂盒分别进行初筛和复检实验是减少假阴性结果,保障血液安全的重要手段.%To explore the reason of conflict test results by using anti-HCV ELISA reagents from different companies, 175 serum samples were tested by using anti-HCV reagents from four domestic and two foreign companies.17 samples with conflicted results and 1 sample with weak positive result in these 175 samples were tested by using anti-HCV sub-fragment ELISA reagents respectively. The results were statistically analyzed with SPSS13.0 software. The results showed that 85 samples were negative, 38 were positive, and 52 had discordant results among the 175 samples tested by using reagents from 6 different companies. The results of 18 discordant resulting samples tested by anti-HCV sub-fragment reagent showed that the false negative rate of reagent I, Ⅱ, Ⅲ, Ⅳ, V and Ⅵ were 75％ (9/12), 25％ (3/12), 66.67％ (8/12), 33.33％ (4/12), 58.33％ (7/12), 33.33％ (4/12), respectively. The false negative rate of the result obtained by reagent plus reagent V combination test was 8.33％, which was significantly reduced. The different antigen components coated on test tubes was the important factor for conflicted detecting results. Therefore, preliminary screening and re-inspection using reagents coating with complementary antigen components is an important method for reducing false negative rate and for the safeguard of samples safety.
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