国产抗HCVEIA试剂漏检原因分析

Analysis on the Quality of Anti-HCV EIR (Version 3.0) Kits

分析第三代丙型肝炎病毒抗体酶联免疫诊断试剂检测抗体情况 ,分析国产抗HCVEIA试剂漏检原因。对 1 0 0批通过国家第三代第二批参考品检定合格的第三代丙型肝炎病毒抗体酶联免疫诊断试剂检定结果进行分析 ,结合RIBA结果进行综合评价。目前的第三代丙型肝炎病毒抗体酶联免疫诊断试剂在通过国家第三代第二批参考品的基础上仍有漏检 ,尤以NS3区及核心区抗体弱阳性血清漏检为严重 ,进口试剂的特异度优于国产试剂。第三代丙型肝炎病毒抗体酶联免疫诊断试剂对NS3区及核心区抗体弱阳性血清检测灵敏度需进一步加强 。

To investigate the quality of anti-HCV EIR (version 3 0) kits, the 80 sera from Chinese National Reference Panel for anti-HCV EIA kits (100 lots) are analyzed. The results from domestic and imported kits were compared, and the possible false negative reason of domestic anti-HCV EIA kits was analyzed according RIBA. False negative samples were found from both domestic and imported anti-HCV EIA kits. Most of them contain weak anti-HCV core or NS 3 antibodies. This may mean that the quality HCV antigens used in the anti-HCV EIA kits must be improved, including the activity and purity of the antigens. In general, the sensitivity and specificity of imported anti-HCV EIA kits are better than the domestic ones.