HLA-B27核酸检测试剂的首次质量分析研究  

The first quality analysis study of HLA-B27 nucleic acid detection reagents

作　　者：胡泽斌[1] 游延军 张文新 张咪 于婷[1] 高飞[1] HU Zebin;YOU Yanjun;ZHANG Wenxin;ZHANG Mi;YU Ting;GAO Fei(National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of In vitro Diagnostic Reagents,Beijing,China,100050;Sichuan Technical Inspection Center For Medical Products,Chengdu,China,610017)

机构地区：[1]中国食品药品检定研究院,国家药品监督管理局体外诊断试剂质量研究与评价重点实验室,北京100050 [2]四川省药品技术检查中心,成都610017

出　　处：《分子诊断与治疗杂志》2025年第2期338-341,共4页Journal of Molecular Diagnostics and Therapy

基　　金：中国食品药品检定研究院学科带头人基金(2023X1)。

摘　　要：目的通过2022年国家医疗器械监督抽验实施,对已上市的HLA-B27核酸检测试剂盒进行首次质量分析。方法使用企业获得批准的产品技术要求、以及HLA-B27核酸检测国家参考品和新修订的HLA基因分型检测试剂盒行业标准,评价不同企业的HLA-B27核酸检测试剂盒的关键性能指标,包括准确性、特异性、检测限。结果抽到的3批次B27检测试剂的准确性、特异性检测结果均符合法定检验要求、2批次B27试剂的检测限项目的检测结果均法定检验要求,1批次B27试剂产品技术要求未设置检测限指标,本次法定检验的合格率为100%。探索性研究中2批次B27试剂的准确性、特异性检测结果均满足国家参考品和行业标准的相应要求,1批次B27试剂的检测限项目的检测结果满足国家参考品和行业标准的相应要求。结论本次监督抽验获得的3家HLA-B27核酸检测试剂盒质量状况整体良好,但存在个别产品技术要求漏项的情况,需要加强监管机构、检验机构和责任主体生产企业之间的通力合作,进一步提升产品质量。Objective To conduct the quality analysis of HLA-B27 nucleic acid testing kits that have been launched through the implementation of national medical device supervision sampling in 2022 for the first time.Methods The key performance indicators of HLA-B27 nucleic acid testing kits from different enterprises were evaluated including accuracy,specificity,and detection limit,using the approved product technical requirements of the enterprise,as well as the national reference materials for HLA-B27 nucleic acid testing and the updated industry standards for HLA genotyping testing kits.Results The accuracy and specificity test results of 3 batches of B27 reagents met the legal test requirements,and the detection limit test results of 2 batches of B27 reagents were all in compliance with the legal test requirements.However,one batch did not set the indicator of detection limits.The pass rate for this legal test is 100%.In the exploratory study,the accuracy and specificity test results of 2 batches of B27 reagents met the corresponding requirements of national reference materials and industry standards.Additionally,the detection limit test results of one batch of B27 reagents also met the corresponding requirements of national reference materials and industry standards.Conclusion The overall quality of the 3 HLA-B27 nucleic acid testing kits obtained from this supervision and sampling is good.However,there are some cases where the technical requirements for certain products are not set reasonably.It is necessary to strengthen cooperation between regulatory agencies,inspection agencies,and responsible production enterprises to further improve product quality.

关 键 词：医疗器械监督抽验 HLA-B27 体外诊断试剂 国家参考品 行业标准 

分 类 号：R927.1[医药卫生—药学]