丙型肝炎病毒抗体诊断试剂(胶体金法)专项抽验情况分析及建议  

Analysis and Suggestions on Sampling Test of Anti-HCV Colloidal Gold-based Immunoassays Kits

作　　者：于洋[1] 李颖 张瑾[1] 谷金莲[1] 段欣欣 周诚[1] Yu Yang;Li Ying;Zhang Jin;Gu Jinlian;Duan Xinxin;Zhou Cheng(National Institutes for Food and Drug Control,Beijing,1000505 China)

机构地区：[1]中国食品药品检定研究院,北京100050

出　　处：《中国药事》2021年第3期274-280,共7页Chinese Pharmaceutical Affairs

摘　　要：目的:了解丙型肝炎病毒抗体诊断试剂(胶体金法)在生产、流通、使用环节的总体质量情况,为丙型肝炎病毒抗体诊断试剂(胶体金法)的质量监测及质量管理提供参考。方法:用抽验试剂根据行业标准YY/T 1215—2013规定的丙型肝炎病毒抗体快速检测试剂国家参考品进行检测,并用WHO HCV Seroconversion Panel PHV917(M)HCVGenotype 2b和HCVHepatitis C Seroconversion Panel PHV919(0610-0217)HCV Genotype 1a血清转换盘对部分产品进行检测,比较不同产品灵敏度差异。结果与结论:按行业标准生产的34批抽验样品中33批符合行业标准YY/T 1215—2013要求,但对WHO HCV系列血清检测阳转时间有差异,另有1批因无法加样而不符合要求,说明国产丙型肝炎病毒抗体检测试剂(胶体金法)总体质量较好,但试剂灵敏度有差异;本次抽验涉及20个批准文号,占全部该类企业批准文号的50%,建议以后扩大抽样覆盖范围并研制丙型肝炎病毒系列血清转换盘。Objective:To understand the overall quality of Anti-HCV Colloidal Gold-based Immunoassay Kits in the process of production,circulation and use for the benefit of the quality control and supervision.Methods:Sampling reagents were tested according to the national reference material for rapid detection of anti-HCV Colloidal Gold-based Immunoassays stipulated by the trade standard YY/T 1215—2013.Some products were tested with WHO Seroconversion Panel PHV917(M)HCV Genotype 2 b and Seroconversion Panel PHV919(0610-0217)HCV Genotype 1 a to compare the sensitivity differences of different sample kits.Results and Conlusion:Of the 34 batches of samples which were produced according to the industry standards,33 batches met the requirements of industry standard YY/T 1215-2013 although the positive conversion time was different in the serum detection of WHO HCV series.One batch did not meet the requirements due to the inability to add samples,indicating that the overall quality of domestic Anti-HCV Colloidal Gold-based Immunoassay Kits was good,although the sensitivity of the sample reagents was different.This sampling test has involved 20 approval numbers,accounting for 50%of the total approval numbers for such enterprises.It is suggest to extend the sampling scope and develop a series of national HCV Seroconversion Panels.

关 键 词：丙型肝炎病毒抗体 胶体金法 抽验 血清转换盘 

分 类 号：R392-33[医药卫生—免疫学] R95[医药卫生—基础医学]