化学发光法检测SARS-CoV-2抗体试剂诊断效能比较及抗体筛查策略探讨  

Comparison of Diagnostic Efficiency of SARS-COV-2 Antibody Reagent Detected by Chemiluminescence Assay and Antibody Screening Strategies

作　　者：邓杰伦 王远芳[1] 敖科萍 吴重阳 吴思颖[1] 李冬冬[1] 谢轶[1] Deng Jielun;Wang Yuanfang;Ao Keping(Department of Experimental Medicine,West China Hospital,Sichuan University,Chengdu,Shichuan 610041,China)

机构地区：[1]四川大学华西医院实验医学科,四川成都610041

出　　处：《四川医学》2021年第1期78-81,共4页Sichuan Medical Journal

基　　金：四川大学华西医院新型冠状病毒肺炎疫情科技攻关项目(编号:HX-2019-nCov-050)。

摘　　要：目的研究新型冠状病毒肺炎(COVID-19)患者特异性抗体免疫球蛋白(Ig)M、免疫球蛋白(Ig)G及总抗体动态变化规律,评价应用化学发光在COVID-19诊断中的可靠性及诊断效能,并通过抗体血清学转化探讨普通人群筛查策略,为科学地防治COVID-19提供理论依据。方法收集我院2020年1月25日至3月17日就诊患者89例,共计142份血清,其中16例确诊COVID-19患者的不同采血时间点共69份血清作为病例组,73例核酸阴性的排除患者共73份血清作为对照组。采用全自动化学发光免疫分析技术对收集血清进行新型冠状病毒(SARS-CoV-2)IgM、IgG和总抗体检测。结果IgM检测的敏感度为40.58%(28/69),特异度为98.63%(72/73),符合率为70.42%(100/142);IgG检测的敏感度为89.86%(62/69),特异度为98.63%(72/73),符合率为94.37%(134/142);总抗体检测的敏感度为95.65%(66/69);特异度为98.63%(72/73);符合率为97.18%(138/142)。所有抗体在发病1周内检测阳性率较低,从第2周开始,抗体阳性率逐步升高。IgM抗体在第5周阳性率达70%的峰值,从第6周开始逐渐降低;IgG从第3周开始阳性率持续维持在100%,总抗体从第2周开始阳性率持续维持在100%。结论化学发光法检测SARS-CoV-2抗体可作为COVID-19感染的有效筛查和诊断指标,相比较而言总抗体检测效能优于单独检测IgM或IgG。作为普通人群筛查时,抗体检测结果应进行动态监测及跟踪随访。Objective To study the dynamic changes of specific antibodies,such as immunoglobulin(Ig)M,immunoglobulin(Ig)G and total antibody,in patients with COVID-19.To evaluate the reliability and efficacy of chemiluminescence in the diagnosis of COVID-19.In addition,screening strategie for the general population was discussed through antibody serological transformation,so as to provide theoretical basis for the scientific prevention and treatment of COVID-19.Method A total of 142 serum were collected from 89 patients who visited our hospital between January 25 and March 17,2020.Among them,69 serum,the case group,from 16 patients who confirmed as COVID-19 were collected at different time points,and 73 serum from 73 excluded patients with negative nucleic acid were used as the control group.SARS-COV-2IgM,IgG and total antibody were detected by novel chemiluminescence immunoassay.Result The sensitivity and specificity of IgM detection were 40.58%(28/69),98.63%(72/73)and 70.42%(100/142)respectively.The sensitivity and specificity of IgG detection were 89.86%(62/69),98.63%(72/73)and 94.37%(134/142)respectively.The sensitivity of total antibody detection was 95.65%(66/69).The specificity was 98.63%(72/73).The coincidence rate was 97.18%(138/142).The positive rate of all antibodies was low within 1 week of the onset,and increased gradually from the second week.The positive rate of IgM antibody peaked at 70%at week 5 and gradually decreased from week 6.The positive rate of IgG was maintained at 100%from the third week,and the positive rate of total antibody was maintained at 100%from the second week.Conlusion The detection of SARS-COV-2 antibody by chemiluminescence is an effective screening and diagnostic indicator for COVID-19 infection,and the detection efficiency of total antibody is better than IgM or IgG alone.When screening the general population,the antibody detection results should be dynamically monitored and followed up.

关 键 词：新型冠状病毒 新型冠状病毒肺炎 化学发光法 免疫球蛋白M 免疫球蛋白G 总抗体 筛查策略 

分 类 号：R446.11[医药卫生—诊断学]