新型冠状病毒抗原检测试剂胶体金法企业参考品的建立及应用  

Establishment and Application of the Reference Panel for SARS-CoV-2 Antigen Detection Kits

作　　者：高静贤 张小燕 巫亮 陈涛 GAO Jing-xian;ZHANG Xiao-yan;WU Liang;CHEN Tao(Jiangsu Institute for Medical Device Inspection,Jiangsu Nanjing 210012;Nanjing Shenji Pharmaceutical Technology Co.,Ltd.,Jiangsu Nanjing 210012)

机构地区：[1]江苏省医疗器械检验所,江苏南京210012 [2]南京申基医药科技有限公司,江苏南京210012

出　　处：《中国医疗器械信息》2025年第5期26-29,共4页China Medical Device Information

摘　　要：目的:构建一种针对企业试剂产品的新型冠状病毒抗原检测用参考品,以实现对试剂的质量控制和性能评估。方法:以中国食品药品检定研究院制备的新型冠状病毒抗原检测试剂国家参考品为对照,构建用于验证新型冠状病毒抗原试剂检出性能的企业参考品,对两种参考品进行比较,并对参考品的稳定性进行验证。结果:企业参考品最低检出限S5标定结果为1.25×10^(5) U/mL;国家参考品与企业参考品对应的阴性参考品N1~N20、阳性参考品P1~P8及重复性参考品R1~R3检测结果色阶一致且符合要求;37˚C保存4d,-20℃保存1年或反复进行4次冻融后均不会对企业参考品的稳定性构成影响;试剂的性能验证结果表明,阴性符合率、阳性符合率、重复性结果均满足对应要求。结论:制备的企业参考品性能达到应用要求,可用于对试剂质量的控制和评价。Objective:To construct a reference material for the novel coronavirus antigen detection of enterprise reagent products,in order to achieve quality control and performance evaluation of the reagents.Methods:The national reference kit for SARS-CoV-2 antigen detection provided by The national reference kit for SARS-CoV-2 antigen detection provided by China Institute for Food and Drug Control was used as the standard to establish an enterprise reference kit for SARS-CoV-2 antigen detection.The two reference kits were compared and the stability of the reference kit was verified.Results:The minimum detection limit S5 of the enterprise reference was 1.25×10^(5) U/mL.The color levels of negative reference substance N1-N20,positive reference substance P1-P8 and repeatability reference substance R1-R3 corresponding to the national reference substance and the enterprise reference substance were consistent with the requirements.The stability of the reference material was not affected by storage at 37℃ for 4 days,storage at -20℃ for 1 year and repeated freezing and thawing for 4 times.The results of reagent quality evaluation showed that the negative coincidence rate,the positive coincidence and the repeatability met the requirements.Conclusion:So the standard was used to establish an enterprise reference for SARS-CoV-2 antigen detection,which plays an important role in product quality control of this enterprise.

关 键 词：新型冠状病毒抗原 检测试剂 企业参考品 

分 类 号：R194[医药卫生—卫生事业管理] TH776[医药卫生—公共卫生与预防医学]