国产新型冠状病毒IgG抗体检测试剂盒的性能比较  

Performance comparison of China's SARS-CoV-2 IgG antibody test kits

作　　者：孙莉 朱晋升 代蕾颖 宋伟 杨忠 王会如 SUN Li;ZHU Jin-sheng;DAI Lei-ying;SONG Wei;YANG Zhong;WANG Hui-ru(NMPA Key Laboratory for Quality Evaluation of In Vitro Diagnostics,Beijing Institute of Medical Device Testing,Beijing 101111,China)

机构地区：[1]北京市医疗器械检验所,国家药品监督管理局体外诊断试剂质量评价重点实验室,北京101111

出　　处：《医疗卫生装备》2021年第6期56-59,74,共5页Chinese Medical Equipment Journal

摘　　要：目的:探讨不同国产新型冠状病毒(以下简称“新冠病毒”)IgG抗体检测试剂盒(胶体金法)的阳性符合率、阴性符合率及检出限的差异。方法:选择具有代表性的6种国产新冠病毒IgG抗体检测试剂盒,严格按照其说明书,对15例临床确诊的阳性灭活样本进行阳性符合率测试。并通过20例同期健康体检者阴性灭活样本和国家标准物质(稀释成不同梯度)比较6种试剂盒的阴性符合率及检出限。分析影响试剂盒检测结果阳性符合率、阴性符合率及检出限的因素。结果:6种试剂盒中,阳性符合率在90.0%~100.0%的有3种,在80.0%~<90.0%的有1种,在70.0%~<80.0%的有2种;6种试剂盒的阴性符合率均为100.0%;6种试剂盒的检出限呈梯度分布。结论:试剂盒的特异性识别位点、蛋白表达系统以及说明书的规范程度等因素都会影响试剂盒的检测结果。Objective To explore the differences of China's SARS-CoV-2 IgG antibody test kits(colloidal gold method)in positive rate,negative rate and detection limit.Methods Six representative China's IgG antibody test kits were selected and the positive rates were tested on 15 clinically confirmed positive inactivated samples in strict accordance with their instructions.The negative rates and detection limits of the six kits were compared with 20 negative inactivated samples from the same period of healthy physical examinees and national reference material(diluted into different gradients).The factors influencing the positive rate,negative rate and detection limit of the kits were analyzed.Results Among the six kits,there were three ones had the positive rates between 90.0%and 100.0%,one kit had the positive rate not lower than 80.0%while lower than 90.0%and two ones had the positive rates not lower than 70.0%while lower than 80.0%;all the six kits had the negative rate of 100.0%;the detection limits of the six kits showed a gradient distribution.Conclusion The factors such as the specific recognition site of the kit,the protein expression system and the standardization of the instruction can all affect the results of the kit.

关 键 词：新型冠状病毒 IGG抗体检测 胶体金法 试剂盒 阳性符合率 阴性符合率 检出限 

分 类 号：R318[医药卫生—生物医学工程] R446[医药卫生—基础医学]