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

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...

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

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.