丙型肝炎病毒抗体酶标试剂盒的评价

目的了解国内丙型肝炎病毒抗体酶标诊断试剂盒的质量。方法应用中国国家丙型肝炎病毒抗体参考品及美国ＢＢＩＡｎｔｉ－ＨＣＶｐａｎｅｌ对Ａｂｂｏｔ等四家国外及六家国内丙型肝炎病毒抗体试剂盒进行了评价。结果１９８份中国国家丙型肝炎病毒抗体参考品中的１００份阳性参考品的检出率，Ａｂｂｏｔ试剂盒为９８％，国产试剂盒为９５％～９７％。对２５份ＢＢＩｐａｎｅｌ中的２３份阳性血清，ｐａｎｅｌ检出率Ａｂｂｏｔ等国外试剂盒为８７％～１００％，国产试剂盒为７０％～９１％。结论国产试剂盒所用丙型肝炎病毒抗原结构区抗原与国外试剂一致，但非结构区抗原较弱。提高国产丙型肝炎病毒抗体试剂盒的质量，应增加高质量的非结构区抗原的应用

Evaluation on the anti-hepatitis C virus enzyme-linked immunosorbent diagnostic kits

Ten different anti-HCV ELISA kits, four manufactured from abroad (ABBOTT, Innogenetics, Murex, Monolisa) and six in China, were evaluated by China national anti-HCV panel(100 positive, 98 negative) and Boston Biomedical Inc. (BBI) anti-HCV mixted titer performance panel(23 positive and 2 negative). The detective rates in 100 China national anti-HCV positive panel were 98% by ABBOTT EIA 2.0, 96% by BHY, SKH and XWK, 95% by BBS and HHM, 97% by SCJ, and that in 23 BBI anti-HCV positive panel were 100% by ABBOTT EIA2.0, but 91% by Murex, 87% by Innogenetics and Monolisa, 74% by BHY, 87% by SKH, 83% by XWK and HHM, 70% by BBS, 91% by SCJ. The specificity for all negative panels were similar in all kits. According to the results of HCV RIBA test (Ortho HCV RIBA 2.0), the structural antigens contained in all kits were almost the same, but the antigenicity of HCV nonstructural proteins were different, in the kits made in China they were lower than that made from abroad.