Liu Pan-Pan, Zong Yang, Jiang Shu-Peng, Jiao Yong-Jun, Yu Xue-Jie
State Key Laboratory of Virology, School of Health Sciences, Wuhan University, Wuhan 430071, Hubei Province, P. R. China.
High School Affiliated to Nanjing Normal University, Nanjing 210003, Jiangsu Province, P. R. China.
ACS Omega. 2021 Apr 1;6(14):9667-9671. doi: 10.1021/acsomega.1c00253. eCollection 2021 Apr 13.
SARS-CoV-2 is the etiologic agent of COVID-19, which has led to a dramatic loss of human life and presents an unprecedented challenge to public health worldwide. The gold standard assay for SARS-CoV-2 identification is real-time polymerase chain reaction; however, this assay depends on highly trained personnel and sophisticated equipment and may suffer from false results. Thus, a serological antibody test is a supplement to the diagnosis or screening of SARS-CoV-2. Here, we develop and evaluate the diagnostic performance of an IgM/IgG indirect ELISA method for antibodies against SARS-CoV-2 in COVID-19. The ELISA was constructed by coating with a recombinant nucleocapsid protein of SARS-CoV-2 on an enzyme immunoassay plate, and its sensitivity and specificity for clinical diagnosis of SARS-CoV-2 infection was assessed by detecting the SARS-CoV-2-specific IgM and IgG antibodies in COVID-19 patient's sera or healthy person's sera. The SARS-CoV-2 positive serum samples ( = 168) were collected from confirmed COVID-19 patients. A commercial nucleocapsid protein-based chemiluminescent immunoassay (CLIA) kit and a colloidal gold immunochromatography kit were compared with those of the ELISA assay. The specificity, sensitivity, positive predictive value (PPV), and negative predictive value (NPV) of IgM were 100, 95.24, 100, and 91.84%, whereas those of IgG were 100, 97.02, 100, and 94.74%, respectively. We developed a highly sensitive and specific SARS-CoV-2 nucleocapsid protein-based ELISA method for the diagnosis and epidemiologic investigation of COVID-19 by SARS-CoV-2 IgM and IgG antibody detection.
严重急性呼吸综合征冠状病毒2（SARS-CoV-2）是冠状病毒病（COVID-19）的病原体，它已导致大量人员死亡，并给全球公共卫生带来了前所未有的挑战。用于SARS-CoV-2鉴定的金标准检测方法是实时聚合酶链反应；然而，该检测方法依赖于训练有素的人员和精密的设备，并且可能会出现假结果。因此，血清学抗体检测是对SARS-CoV-2诊断或筛查的一种补充。在此，我们开发并评估了一种用于检测COVID-19患者中抗SARS-CoV-2抗体的IgM/IgG间接酶联免疫吸附测定（ELISA）方法的诊断性能。该ELISA方法通过在酶免疫测定板上包被SARS-CoV-2的重组核衣壳蛋白构建而成，通过检测COVID-19患者血清或健康人血清中的SARS-CoV-2特异性IgM和IgG抗体，评估其对SARS-CoV-2感染临床诊断的敏感性和特异性。从确诊的COVID-19患者中收集了168份SARS-CoV-2阳性血清样本。将一种基于核衣壳蛋白的商业化学发光免疫分析（CLIA）试剂盒和一种胶体金免疫层析试剂盒与ELISA检测方法进行了比较。IgM的特异性、敏感性、阳性预测值（PPV）和阴性预测值（NPV）分别为100%、95.24%、100%和91.84%，而IgG的分别为100%、97.02%、100%和94.74%。我们通过检测SARS-CoV-2 IgM和IgG抗体，开发了一种基于SARS-CoV-2核衣壳蛋白的高灵敏度和特异性的ELISA方法，用于COVID-19的诊断和流行病学调查。
