已上市HLA⁃B^(*)5801核酸检测试剂盒的质量评估  

Quality assessment of HLA⁃B^(*)5801 nucleic acid detection kis that have been launched on the market

作　　者：胡泽斌[1] 沈宣辛 张文新 张咪 于婷[1] 孙楠[1] HU Zebin;SHEN Xuanxin;ZHANG Wenxin;ZHANG Mi;YU Ting;SUN Nan(National Institutes for Food and Drug Control,NMPA Key Laboratory for Quality Research and Evaluation of In vitro Diagnostic Reagents,Beijing,China,100050;Jilin Institute of Medical Device Inspection,Changchun,Jilin,China,130062)

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]吉林省医疗器械检验研究院,吉林省长春130062

出　　处：《分子诊断与治疗杂志》2025年第1期9-12,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：目的通过监督抽验,对已上市HLA⁃B^(*)5801核酸检测试剂盒进行首次质量评估。方法依据获批产品技术要求,对已上市HLA⁃*B5801核酸检测试剂盒的准确度、检出限和特异性等关键性能指标进行法定检验,并采用标准物质和行业标准相结合的方式,对抽样试剂质量进行探索性研究。结果法定检验中,3家HLA⁃B^(*)5801核酸检测试剂盒的准确性和特异性项目均合格,其中1家HLA⁃B^(*)5801核酸检测试剂盒的检测限项目中有部分不合格;探索性研究中,3家HLA⁃B^(*)5801核酸检测盒的准确度、检出限和特异性结果均满足国家参考品和新行业标准的相应要求。结论本次监督抽验获得的3家HLA⁃B^(*)5801核酸检测试剂盒总体质量较好。Objective To conduct the quality risk assessment of HLA⁃B^(*)5801 nucleic detection kits that have been launched on the market through supervision and sampling for the first time.Methods Ac⁃cording to the technical requirements of the approved product,the accuracy,detection limit,and specificity of the HLA⁃B^(*)5801 nucleic acid detection kits that have been launched on the market were legally tested.An ex⁃ploratory study was conducted on the quality of sampling reagents using a combination of national standard mate⁃rials and new industry standards.Results In the legal test,the accuracy and specificity items of three HLA⁃B^(*)5801 nucleic acid testing kits were all qualified,and some of the detection limit items of one HLA⁃B^(*)5801 nucleic acid testing kit were found to be unqualified.In the exploratory study,the accuracy,detection limit,and specificity results of three HLA⁃B^(*)5801 nucleic acid test kits all met the corresponding requirements of both na⁃tional reference standards and new industry standards.Conclusion The overall quality of the three HLA⁃B^(*)5801 nucleic acid detection kits obtained from this supervision and sampling was good.

关 键 词：质量评估 HLA⁃B^(*)5801 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]