CAJ | 학술논문

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.
목적 대아국병형간염병독IgG항체(HCV-IgG) ELISA검측시제진행질량비교,위병간방치제공삼고.방법 선택국내6개엄가생산적HCV-IgG항체적ELISA검측시제합,편호위A、B、C、D、E화F,대160빈의사HCV감염자혈청양본진행검측,이ABBOTT공사HCV-IgG시제위표준,회구양본용RIBA법진행복핵.결과 160빈혈청양본중88빈위HCV-IgG양성,72빈위음성.6개엄가시제여표준결과비교총부합솔위88.13％～98.13％,약등지수분별위0.74 ～ 0.96,D시제적총부합솔화약등지수최고,분별위98.13％,0.96.결론 국내6개엄가적HCV-IgG항체검측시제여ABBOTT표준결과적총부합솔균능체도88％이상,구유교고적일치성,단개별엄가적음성부합솔교저.
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.