丙型肝炎病毒抗体诊断试剂质量评估

目的对国内外不同厂家的丙型肝炎(丙肝)病毒的15种酶联免疫吸附法(ELISA)诊断试剂及8种胶体金法诊断试剂的质量进行评价。方法使用国家艾滋病参比室基础血清盘、参比室干扰血清盘、商业阳转血清盘,以阳性符合率、阴性符合率等指标评价试剂的质量。结果共检测80份样本,15种丙肝ELISA试剂的阳性符合率、阴性符合率均≥97.5%(39/40);8种丙肝胶体金试剂阳性符合率为82.5%～100%(33/40～40/40),阴性符合率均≥97.5%(39/40)。对阳转血清盘检测,ELISA试剂的平均延长天数分布于8-19天之间。丙肝ELISA和胶体金试剂的分析特异性均为100%。结论参评的ELISA试剂具有较高的阳性符合率和阴性符合率。胶体金试剂的阴性符合率较高、阳性符合率有差异。丙肝ELISA试剂适合于中国一般人群的筛查检测。丙肝胶体金试剂的敏感性有待于进一步提高。

Evaluation of quality of HCV reagent kits

Objective To evaluate quality of 15 HCV ELISA reagent kits and 8 Colloid Gold reagent kits.Methods Fifteen-HCV ELISA kits and eight HCV Colloid Gold reagent kits,both domestic and foreign,were evaluated by three serum panels including AIDS Reference Lab master panel,BBI seroconversion panel and AIDS Reference Lab cross-reacting panel.Evaluation indexes contained positive agreement ratio and negative agreement ratio.Results The sensitivity and specificity of the ELISA kits were above 97.5%(39/40);the sensitivity of the Colloid Gold kits was between 82.5% and 100%(33/40-40/40),while the specificity was above 97.5%(39/40).Based on seroconversion panel,the mean delay of the fifteen ELISA kits was between 8 and 19 days.The analytic specificity of both the ELISA kits and the Colloid Gold kits was 100%.Conclusion The positive and negative agreement ratios of 15 anti-HCV ELISA kits were both high.The HCV Colloid Gold kits had high negative agreement ratio,but different positive agreement ratio.HCV ELISA is applicable for screening the general population.The sensitivity of HCV antibody Colloid Gold kits needs to be further improved.