按2010版《中国药典》要求研制的丙型肝炎病毒抗体检测试剂性能验证

Performance verification of anti-HCV test kit developed according to requirement of Chinese Pharmacopoeia 2010 version

目的对按新版《中国药典》要求研制的丙型肝炎病毒抗体(下称丙肝抗体)试剂的方法学性能进行评价和分析。方法结合美国临床实验室标准化协会(CLIS)发布的EP12-A2文件《定性试验评价方法用户协议和提议指南》和中国合格评定国家认可委员会(CNAS)颁发的《医学实验室质量和能力认可准则在临床免疫学检验领域的指南》对丙肝抗体进行性能评价。结果丙肝抗体定性试验的临界值为0.3NCU/mL;诊断敏感性为95.83%,特异性为100%,符合率为97.5%;批内精密度高值:12.94%,低值:13.67%;批间精密度CV是14.83%。结论丙肝抗体试剂的方法学性能符合2010版《中国药典》要求,且比以前同类产品检测性能优良。

Objective To perform the performance verification of the anti-HCV test kit developed according to requirement of the 2010 version of Chinese Pharmacopoeia.Methods According to the Clinical and Laboratory Standards Institute（CLSI） document EP12-A2 User Protocol for Evaluation of Qualitative Test Performance,Approved Guideline and China National Accreditation Service for Conformity Assessment（CNAS） document Guidance on the Application of Medical Laboratory Quality and Competence Accreditation Criteria in the Fields of Clinical Immunology,the performances of anti-HCV was evaluated.Results The critical concentration at HCV blood serum in our laboratory was 0.3 NCU/mL.Sensitivity：95.83%,specificity：100%,compliance rate：97.5%.Strong positive CV of within-run precision：≤12.94%,weak positive：13.67%.Between-run precision：14.83%.Conclusion The performance verification of the anti-HCV test kit is accord with requirement of Chinese Pharmacopoeia 2010 version and better than previous similar products.