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. 2020 Dec;39(12):2271-2277.
doi: 10.1007/s10096-020-03978-6. Epub 2020 Jul 17.

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

Dachuan Lin  1 , Lei Liu  2 , Mingxia Zhang  2 , Yunlong Hu  1 , Qianting Yang  2 , Jiubiao Guo  1 , Youchao Dai  1 , Yuzhong Xu  3 , Yi Cai  1 , Xinchun Chen  1 , Kaisong Huang  4 , Zheng Zhang  5
Affiliations

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

Dachuan Lin et al. Eur J Clin Microbiol Infect Dis. 2020 Dec.

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: Chemiluminescence immunoassay; IgM and IgG; SARS-CoV-2; Serological testing.

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Conflict of interest statement

The authors declare that they have no conflict of interest.

Figures

Fig. 1
Fig. 1
Detections and measurements of the SARS-CoV-2 IgM and IgG antibody in healthy people, tuberculosis patients, and SARS-CoV-2 confirmed patients using the chemiluminescence immunoassay method (a and b). The average results were expressed as mean ± SEM of all individuals. Receiver operating characteristic curves for IgM (c) and IgG (d) were obtained based on the RLU for the SARS-CoV-2 patient group and the control group consisting of healthy cohorts and tuberculosis patients
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