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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
邓杰伦, 王远芳, 敖科萍, 吴重阳, 吴思颖, 李冬冬, 谢轶
四川大学华西医院实验医学科,四川 成都 610041
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。
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
DOI:10.16252/j.cnki.issn1004-0501-2021.01.018
分类号:R446.11
文章编号:1004-0501(2021)01-0078-04
文献标识码:A
基金项目: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)
Comparison of Diagnostic Efficiency of SARS-COV-2 Antibody Reagent Detected by Chemiluminescence Assay and Antibody Screening Strategies.
Deng Jielun, Wang Yuanfang, Ao Keping, Wu Zhongyang, Wu Siying, Li Dongdong, Xie Die
Department of Experimental Medicine, West China Hospital, Sichuan University, Chengdu,Shichuan 610041 , China.
Abstract:
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.
Key words:  SARS-CoV-2  corona virus disease 2019  chemiluminescence  immunoglobulin M  immunoglobulin G  total antibodies  screening strategy
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