三种化学发光法检测新型冠状病毒(SARS-CoV-2)抗体试剂盒的临床应用评价  

Evaluation of Clinical Application of Three Chemiluminescence Detection Kits for Detection of Novel Coronavirus(SARS-CoV-2)Antibody

作　　者：胡纪文 王恩运 阚丽娟 豆小文 赖柚霞 徐莎 姜瑞伟 张秀明 HU Ji-wen;WANG En-yun;KAN Li-juan;DOU Xiao-wen;LAI You-xia;XU Sha;JIANG Rui-wei;ZHANG Xiu-ming(Medical Labouatory Center,Shenzhen Luohu Hospital Group,Guangdong Shenzhen 518001,China)

机构地区：[1]深圳市罗湖医院集团医学检验中心,广东深圳518001

出　　处：《现代检验医学杂志》2020年第4期100-105,共6页Journal of Modern Laboratory Medicine

基　　金：国家自然科学基金面上项目(81872076);深圳市医疗卫生三名工程项目(SZSM201601062)。

摘　　要：目的评价三种新型冠状病毒(SARS-CoV-2)抗体化学发光试剂盒的检测性能,研究SARS-CoV-2抗体检测的临床应用价值。方法采用37例临床确诊新型冠状病毒肺炎(COVID-19)患者恢复期血清样本和100例对照患者血清样本,对三个不同厂家的化学发光新型冠状病毒抗体检测试剂盒进行评估。绘制ROC曲线分析三种试剂的检测性能。利用Kappa统计分析三种试剂的检测一致性。结果对于IgM抗体检测,试剂A和试剂B具有非常好的检测性能,尤其是试剂B性能最优,临床敏感度为56.76%,临床特异度为99%;对于IgG抗体检测,三种试剂均具有非常好的检测性能,三种试剂的临床特异度均为97.00%,而试剂C的临床敏感度最高,为97.29%。对于IgM抗体检测,试剂A与试剂B检测结果具有中度一致性(Kappa=0.508,P<0.05),试剂C与试剂B检测结果仅具有微弱一致性(Kappa=0.065,P≥0.05);对于IgG抗体检测,试剂A与试剂C检测结果具有高度一致性(Kappa=0.654,P<0.05),试剂A与试剂B检测结果为弱一致性(Kappa=0.102,P≥0.05)。结论三种化学发光法SARS-CoV-2 IgM和IgG抗体检测试剂盒均具有一定的临床敏感度和特异度,但各厂家产品的检出一致性相差较大,因此产品性能的标准化和工艺标准化亟待解决。Objective To evaluate the performance of three kinds of chemiluminescence immunoassay(CLIA)kitsfor novel Coronavirus(SARS-COV-2)antibody,and study the clinical application of SARS-CoV-2 immunoglobulin M(IgM)and immunoglobulin G(IgG)antibodies detection.Methods Three chemiluminescence novel coronavirus antibody detection kits from three different manufacturers were evaluatedusingserum samples from 37 clinically diagnosed COVID-19 patients in convalescence and 100 control patients.ROC curve was drawn to analyze the detection performance of the three kits.The detection consistency of the three reagents was analyzed using Kappa value.Results For IgM detection,both kit A and kit B had very good detection performance,especially performance of kit B was the best,the clinical sensitivity was 56.76%,the clinical specificity was 99%.For IgG detection,all three kits had perfect performance.The clinical specificity of all three kits was 97.00%,while kit C had the highest clinical sensitivity(97.29%).For IgM detection,the detection results of kit A and kit B were moderately consistent(Kappa=0.508,P<0.05),while those of kit C and kit B were only weakly consistent(Kappa=0.065,P≥0.05);For IgG detection,the detection results of kit A and kit C were highly consistent(Kappa=0.654,P<0.05),while the detection results of kit A and kit B were weakly consistent(Kappa=0.102,P≥0.05).Conclusion The three chemiluminescence IgM and IgG antibody detection kits all had certain clinical sensitivity and specificity,but the consistency of kits from different manufacturers was quite different,so the standardization of product performance and process needs to be solved.

关 键 词：新型冠状病毒 化学发光免疫分析法 抗体检测 性能评价 

分 类 号：R373.19[医药卫生—病原生物学] R446[医药卫生—基础医学]