10种新型冠状病毒抗体检测试剂盒效果评价  

Evaluation of 10 kits for antibody detection of SARS-CoV-2

作　　者：刘威 杨超杰 瞿良 柯跃华 陈勇 贾瑞忠 刘雄 贾雷立 王勇 韩黎 常国辉 王长军 LIU Wei;YANG Chao-jie;QU Liang;KE Yue-hua;CHEN Yong;JIA Rui-zhong;LIU Xiong;JIA Lei-li;WANG Yong;HAN Li;CHANG Guo-hui;WANG Chang-jun(Wuhan Huoshenshan Hospital,Wuhan 430100,China;The Center for Disease Control and Prevention of People′s Liberation Army,Beijing 100071,China;Joint Support Force 920 Hospital,Kunming 650032,China)

机构地区：[1]武汉火神山医院,武汉430100 [2]解放军疾病预防控制中心,北京100071 [3]联勤保障部队第九二〇医院,昆明650032

出　　处：《国际药学研究杂志》2020年第9期716-721,共6页Journal of International Pharmaceutical Research

基　　金：新冠肺炎疫情防控应急攻关专项任务(YJGG2020-02,YJGG2020-15);“艾滋病和病毒性肝炎等重大传染病防治”国家科技重大专项“细菌性传染病病原谱流行规律及变异研究”课题(2017ZX10103003)。

摘　　要：目的对10种新型冠状病毒抗体检测试剂盒抗体检测敏感性、特异性、符合率和最低检测限进行评价,为新冠肺炎的临床诊断提供数据参考,促进新冠肺炎病毒抗体检测技术的创新改进,同时对新冠病毒抗体检测的应用进行讨论。方法根据10种新冠状毒抗体检测试剂盒说明书,分别对74份血清中特异性IgM和IgG进行检测,同时用10个2倍梯度稀释的样本考察每种试剂盒的最低检测限。结果10种试剂盒(产品A^J)的符合率分别为:89.2%(66/74),89.2%(66/74),86.5%(64/74),95.9%(71/74),52.7%(39/74),75.7%(56/74),86.5%(64/74),79.7%(59/74),50.0%(37/74),20.3%(15/74);在产品A^J对10个2倍梯度稀释样本的最低检测限中,C产品效果最好,对IgM的最低检测限为0.16 AU/ml,对IgG的最低检测限为1.00 AU/ml。结论所试10种新冠病毒抗体检测试剂在敏感性、特异性、符合率和最低检测限方面存在显著差别,因此,在临床应用时应选择敏感性、特异性和符合率较高的产品,以确保检测结果的准确性。Objective To provide data reference for the clinical diagnosis of COVID-19,promote the innovation and improve⁃ment of antibody detection technology of COVID-19,and discuss the application of antibody detection of new coronavirus by evaluat⁃ing the sensitivity,specificity,compliance rate and limit of antibody detection in 10 SARS-CoV-2 antibody detection kits.Methods According to the instructions of 10 new coronavirus antibody detection kits,the specific IgM and IgG in 74 serum samples were detect⁃ed,and the limit of detection of each kit was tested with 10 samples diluted by a 2-fold gradient.Results The coincidence rate of 10 kits(product A-product J)were 89.2%(66/74),89.2%(66/74),86.5%(64/74),95.9%(71/74),52.7%(39/74),75.7%(56/74),86.5%(64/74),79.7%(59/74),50.0%(37/74),20.3%(15/74),respectively.In the detection limit tests for the kits A-J with the 10 of 2x gradient diluted samples,the performance of kit C was the best,with the limit of detection for IgM 0.16AU/ml and the limit of de⁃tection for IgG 1.00 AU/ml.Conclusion There are significant differences in sensitivity,specificity,compliance and limit of detection of 10 new coronavirus antibody testing reagents,and the product of high sensitivity,specificity,and compliance rates should be select⁃ed for clinical applications to ensure the accuracy of test results.

关 键 词：新型冠状病毒 抗体 胶体金 临床诊断 

分 类 号：R18[医药卫生—流行病学]