Evaluations of the serological test in the diagnosis of 2019 novel coronavirus (SARS-CoV-2) infections during the COVID-19 outbreak

• Published in: European journal of clinical microbiology & infectious diseases 2020-12, Vol.39 (12), p.2271-2277
• Main Authors: Lin, Dachuan, Liu, Lei, Zhang, Mingxia, Hu, Yunlong, Yang, Qianting, Guo, Jiubiao, Dai, Youchao, Xu, Yuzhong, Cai, Yi, Chen, Xinchun, Huang, Kaisong, Zhang, Zheng
• Format: Article
• Language: English
• Subjects: Adolescent; Adult; Aged; Antibodies; Antibodies, Viral - blood; Antigens; Beads; Betacoronavirus - immunology; Betacoronavirus - pathogenicity; Biomedical and Life Sciences; Biomedicine; Biotechnology; Case-Control Studies; Chemiluminescence; China - epidemiology; Clinical Laboratory Techniques - methods; Coronaviridae; Coronavirus Infections - blood; Coronavirus Infections - diagnosis; Coronavirus Infections - epidemiology; Coronavirus Infections - immunology; Coronavirus Nucleocapsid Proteins; Coronaviruses; COVID-19; COVID-19 Testing; Diagnosis; Enzyme-linked immunosorbent assay; False Positive Reactions; Female; Humans; Immunoassay; Immunoassay - methods; Immunoglobulin G; Immunoglobulin G - blood; Immunoglobulin M; Immunoglobulin M - blood; Infections; Internal Medicine; Luminescent Measurements - methods; Male; Medical Microbiology; Middle Aged; Nucleocapsid Proteins - blood; Nucleocapsids; Original; Original Article; Pandemics; Phosphoproteins; Plasmas (physics); Pneumonia, Viral - blood; Pneumonia, Viral - diagnosis; Pneumonia, Viral - epidemiology; Pneumonia, Viral - immunology; Polymerase chain reaction; SARS-CoV-2; Sensitivity; Sensitivity and Specificity; Severe acute respiratory syndrome coronavirus 2; Severity of Illness Index; Tuberculosis; Viral diseases
• ISSN: 0934-9723; 1435-4373
• DOI: 10.1007/s10096-020-03978-6

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.