丙型肝炎IgG抗体ELISA诊断试剂比对分析

Comparison of ELISA diagnostic kits used in China for hepatitis C virus IgG antibody detection

目的 对我国丙型肝炎病毒IgG抗体（HCV-IgG） ELISA检测试剂进行质量比较,为丙肝防治提供参考.方法 选择国内6个厂家生产的HCV-IgG抗体的ELISA检测试剂盒,编号为A、B、C、D、E和F,对160份疑似HCV感染者血清样本进行检测,以ABBOTT公司HCV-IgG试剂为标准,灰区样本用RIBA法进行复核.结果 160份血清样本中88份为HCV-IgG阳性,72份为阴性.6个厂家试剂与标准结果比较总符合率为88.13％ ～98.13％,约登指数分别为0.74 ～ 0.96,D试剂的总符合率和约登指数最高,分别为98.13％,0.96.结论 国内6个厂家的HCV-IgG抗体检测试剂与ABBOTT标准结果的总符合率均能达到88％以上,具有较高的一致性,但个别厂家的阴性符合率较低.

Objective To compare the commercial diagnostic reagent available in China for hepatitis C virus （HCV） IgG antibody detection in order to provide some useful information for HCV prevention.Methods The HCV-IgG detection reagents produced by six different Enterprises named A,B,C,D,E and F were chosen and applied to detect 160 HCV specious sera samples.HCV-IgG reagent from ABBOTT was adopted as gold-standard and the samples in gray zone were determined by RIBA method finally.Results 160 sera samples comprised 88 positive samples and 72 negative samples.The total conformity ranged from 88.13％ to 98.13％ and the Youden indexes ranged from 0.74 to 0.96 when the reagents from six different Enterprises were compared with gold-standard.The highest conformity was 98.13％,observed in D reagent with the highest Youden index of 0.96.Conclusion The total conformity rates were more than 88％ when the HCV-IgG antibody detection reagents from six different Enterprises were compared with ABBOTT reagent.It was highly conformable.However,some reagent proved to be less conformable in negative samples detection.