摘要
目的对新型冠状病毒检测试剂盒进行质量评价,为市场监管提供参考。方法使用中国食品药品检定研究院生产的新型冠状病毒抗原检测试剂国家参考品,按说明书进行稀释后,检测从经营环节抽检的16个国内厂家的60批次新型冠状病毒抗原检测试剂盒的阴性符合率、阳性符合率、最低检测限和重复性。结果阴性符合率和阳性符合率均为100%,重复性结果均为阳性,且显色度均一。最低检测限结果均符合国家参考品说明书的规定,不同厂家产品的最低检测限在6.25×10^(4)~5×10^(5)U/ml之间,且相同厂家不同批次产品的结果也存在差异。结论本次抽检的60批次新型冠状病毒抗原检测试剂盒均符合标准及国家参考品说明书的要求,满足使用及本次抽检方案的要求。
Objective To evaluate the quality of novel coronavirus detection kits and provide reference for market supervision.Methods With the use of the national reference substance of novel coronavirus antigen detection reagent produced by the China Institute for Drug and Food Control,after diluting according to the instructions,the negative coincidence rate,positive coincidence rate,minimum detection limit and repeatability of 60 batches of novel coronavirus antigen kits sampled from markets produced by 16 domestic manufacturers were tested.Results Both the negative coincidence rate and positive coincidence rate were 100%,the repeatability results were positive,and the color rendering was uniform.The minimum detection limit results were all in line with regulations on the national reference manual,and the minimum detection limits of products produced by different manufacturers were between 6.25×10^(4)U/ml and 5×10^(5)U/ml,and the results of different batches of products from the same manufacturer were also different.Conclusion The 60 batches of novel coronavirus antigen detection kits for this sampling inspection all meet the requirements of the standard and the instructions of national reference substance,and meet the requirements of use and this sampling inspection scheme.
作者
严诗云
潘晓芳
汤智
曹春玲
韩芝斌
Yan Shiyun;Pan Xiaofang;Tang Zhi;Cao Chunling;Han Zhibin(Guangdong Medical Devices Quality Surveillance and Test Institute,Guangzhou Guangdong 510663,China)
出处
《医疗装备》
2023年第24期38-41,共4页
Medical Equipment
基金
重点科技产业质量基础共性技术研究及应用(2020B0404010002)。
