国内丙型肝炎病毒抗体酶联免疫法试剂评价参考品体系的建立

Establishment of the evaluation reference system for domestic anti-hepatitis C virus diagnostic enzyme immunoassay kits

目的建立国内丙型肝炎病毒抗体酶联免疫法(EIA)诊断试剂评价参考品。方法收集2009-03/2010-10期间来自全国不同省份4833份供血人员血清样品,用国产5种抗HCV EIA试剂和国外2种抗HCV EIA试剂分别进行初筛和复检;用Chiron的RIBA HCV 3.0 SIA、Roche HCV定量试剂对筛选样品进行了确认试验,对确认阳性样品进行HCV基因型检测;选择不同强度的确认阳性、阴性样品、混合阳性系列稀释样品、部分特殊样品等建立抗HCV诊断试剂评价参考品。结果设立了抗HCV诊断试剂评价参考品,包含30份强、中、弱阳性的抗HCV混合阳性样品,10份单片段抗体阳性确认阳性样品,6份评价灵敏度系列稀释样品,30份抗HCV确认阴性样品。结论本研究设立的抗HCV评价参考品检测结果可靠,样品涵盖背景丰富,对新产品研发和筛选评价高质量的抗HCV诊断试剂有一定参考价值。

Objective To establish the evaluation reference for domestic anti-hepatitis C virus （HCV） enzyme immuno- assay （EIA） diagnostic kits. Methods 4833 serum samples which were collected from different provinces of China were screened with 5 domestic anti-HCV EIA kits and redetected with 2 foreign anti-HCV EIA kits. Then the selected samples were confirmed with Chiron RIBA HCV 3.0 SIA and real-time quantitative PCR reagents. The confirmed positive samples were examined for HCV genotypes. The positive samples （classified as low, medium and high titers）, negative samples, mixed- titer positive dilution samples and special samples were selected for preparing the evaluation reference for anti-HCV diagnostic reagent kits. Results The established evaluation reference consisted of 30 positive serum samples including high, medium and low titers, and 10 single band samples confirmed by RIBA, and 6 dilution samples to evaluate the sensitivity, and 30 confirmed negative samples including some high negative value samples and interferential samples. Conclusion The evalua- tion reference samples could offer dependable detection results, and covered abundant antibody repertoire, thus providing important reference for the improvement of the qualities of domestic anti-HCV EIA kits.