丙型肝炎病毒抗体酶标试剂盒的评价
丙型肝炎|诊断试剂,关键词：
关键词：丙型肝炎；诊断试剂
【摘要】 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BBI Anti-HCV panel对Abbott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，Abbott试剂盒为98%，国产试剂盒为95%～97%。对25份BBI panel中的23份阳性血清，panel检出率Abbott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 Zhou Chen,Qi Zibai,Gu Jinlian,et al.National Institute for the Control of Pharmaceutical and Biological Products,Beijing 100050
Abstract Ten different anti-HCV ELISA kits,four manufactured from abroad (ABBOTT,lnnogenetics,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.
Key words: Hepatitis C Diagnostic kit
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