Evaluations of the serological test in the diagnosis of 2019 novel coronavirus (SARS-CoV-2) infections during the COVID-19 outbreak
- 17 July 2020
- journal article
- research article
- Published by Springer Science and Business Media LLC in European Journal of Clinical Microbiology & Infectious Diseases
- Vol. 39 (12), 2271-2277
- https://doi.org/10.1007/s10096-020-03978-6
Abstract
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.Keywords
Funding Information
- National Natural Science Foundation of China (81802060)
This publication has 21 references indexed in Scilit:
- Interspecies transmission and emergence of novel viruses: lessons from bats and birdsTrends in Microbiology, 2013
- Field evaluation of TaqMan Array Card (TAC) for the simultaneous detection of multiple respiratory viruses in children with acute respiratory infectionJournal of Clinical Virology, 2013
- Molecular diagnosis of respiratory virus infectionsCritical Reviews in Clinical Laboratory Sciences, 2011
- Development of a real-time PCR for the specific detection of Waddlia chondrophila in clinical samplesEuropean Journal of Clinical Microbiology & Infectious Diseases, 2009
- More and More Coronaviruses: Human Coronavirus HKU1Viruses, 2009
- Severe Acute Respiratory Syndrome Coronavirus as an Agent of Emerging and Reemerging InfectionClinical Microbiology Reviews, 2007
- Detection and pathogenicity of human metapneumovirus respiratory infection in pediatric Italian patients during a winter–spring seasonJournal of Clinical Virology, 2006
- Review of Bats and SARSEmerging Infectious Diseases, 2006
- Human Coronavirus NL63 Infection and Other Coronavirus Infections in Children Hospitalized with Acute Respiratory Disease in Hong Kong, ChinaClinical Infectious Diseases, 2005
- Human Respiratory Coronavirus OC43: Genetic Stability and NeuroinvasionJournal of Virology, 2004