Evaluations of the serological test in the diagnosis of 2019 novel coronavirus (SARS-CoV-2) infections during the COVID-19 outbreak
Evaluations of the serological test in the diagnosis of 2019 novel coronavirus (SARS-CoV-2) infections during the COVID-19 outbreak
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COVID-19 爆发期间血清学检测在诊断 2019 新型冠状病毒（SARS-CoV-2）感染中的评估
DOI：
10.1007/s10096-020-03978-6
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发表时间：
2020-07-17
影响因子：
4.5
通讯作者：
Zhang, Zheng
中科院分区：
文献类型：
--
作者：
Lin, Dachuan;Liu, Lei;Zhang, Zheng
我们建立了一种基于重组核衣壳抗原的化学发光免疫分析法，并通过检测患者体内SARS-CoV-2特异性IgM和IgG抗体，评估其在临床诊断SARS-CoV-2感染中的应用价值。利用全长重组核衣壳抗原和甲酰基磁珠建立化学发光免疫分析法。采用29例健康人群、51例结核病患者和79例确诊SARS-CoV-2患者的血浆，评价化学发光免疫分析法在临床诊断SARS-CoV-2感染中的性能。使用使用相同核衣壳抗原的商用ELISA试剂盒（中国大瑞生物技术公司）与我们的化学发光免疫分析法进行平行比较。化学发光免疫分析法中IgM和IgG检测方法的敏感性和特异性分别为60.76% （95% CI 49.1 ~ 71.6）、92.25% （95% CI 83.4 ~ 97.2）、82.28% （95% CI 72.1 ~ 90.0）和97.5% （95% CI 91.3 ~ 99.7）。与大瑞生物技术ELISA试剂盒相比，化学发光免疫分析法具有更高的灵敏度和特异性。建立的高灵敏度、高特异性的化学发光免疫分析法IgG检测方法与RT-PCR方法相结合，可提高临床对SARS-CoV-2感染的诊断，有助于控制COVID-19的扩散。
We developed a chemiluminescence immunoassay method based on the recombinant nucleocapsid antigen and assessed its performance for the clinical diagnosis of severe acute respiratory syndrome coronavirus (SARS-CoV)-2 infections by detecting SARS-CoV-2-specific IgM and IgG antibodies in patients. Full-length recombinant nucleocapsid antigen and tosyl magnetic beads were used to develop the chemiluminescence immunoassay approach. Plasmas from 29 healthy cohorts, 51 tuberculosis patients, and 79 confirmed SARS-CoV-2 patients were employed to evaluate the chemiluminescence immunoassay method performance for the clinical diagnosis of SARS-CoV-2 infections. A commercial ELISA kit (Darui Biotech, China) using the same nucleocapsid antigen was used for the in-parallel comparison with our chemiluminescence immunoassay method. The IgM and IgG manner of testing in the chemiluminescence immunoassay method showed a sensitivity and specificity of 60.76% (95% CI 49.1 to 71.6) and 92.25% (95% CI 83.4 to 97.2) and 82.28% (95% CI 72.1 to 90.0) and 97.5% (95% CI 91.3 to 99.7), respectively. Higher sensitivity and specificity were observed in the chemiluminescence immunoassay method compared with the Darui Biotech ELISA kit. The developed high sensitivity and specificity chemiluminescence immunoassay IgG testing method combined with the RT-PCR approach can improve the clinical diagnosis for SARS-CoV-2 infections and thus contribute to the control of COVID-19 expansion.