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

Lin, Dachuan1; Liu, Lei2; Zhang, Mingxia2; Hu, Yunlong1; Yang, Qianting2; Guo, Jiubiao1; Dai, Youchao1; Xu, Yuzhong3; Cai, Yi1; Chen, Xinchun1; Huang, Kaisong1; Zhang, Zheng2

2020-07-17

10.1007/s10096-020-03978-6

EUROPEAN JOURNAL OF CLINICAL MICROBIOLOGY & INFECTIOUS DISEASES   影响因子和分区

0934-9723

1435-4373

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.

SARS-CoV-2 Serological testing Chemiluminescence immunoassay IgM and IgG

SCI

英语

通讯

Guangdong Provincial Science and Technology Program[2019b030301009] ; National Natural Science Funds of China[81802060] ; National Science and Technology Major Project[2017ZX10201301] ; Guangdong province Universities for Special Research Program for COVID-19 control[2020kzdx1175]

Infectious Diseases ; Microbiology

Infectious Diseases ; Microbiology

WOS:000549695400002

SPRINGER

MICROBIOLOGY

Web of Science

1.Shenzhen Univ, Guangdong Prov Key Lab Reg Immun & Dis, Dept Pathogen Biol, Sch Med, Shenzhen, Peoples R China
2.Southern Univ Sci & Technol, Natl Clin Res Ctr Infect Dis, Guangdong Key Lab Diag &Treatment Emerging Infect, Shenzhen Peoples Hosp 3, Shenzhen, Peoples R China
3.Shenzhen Univ, Dept Clin Lab, Shenzhen Baoan Peoples Hosp, Affiliated Hosp 2, Shenzhen, Peoples R China

Lin, Dachuan,Liu, Lei,Zhang, Mingxia,et al. Evaluations of the serological test in the diagnosis of 2019 novel coronavirus (SARS-CoV-2) infections during the COVID-19 outbreak[J]. EUROPEAN JOURNAL OF CLINICAL MICROBIOLOGY & INFECTIOUS DISEASES,2020,39(12).

Lin, Dachuan.,Liu, Lei.,Zhang, Mingxia.,Hu, Yunlong.,Yang, Qianting.,...&Zhang, Zheng.(2020).Evaluations of the serological test in the diagnosis of 2019 novel coronavirus (SARS-CoV-2) infections during the COVID-19 outbreak.EUROPEAN JOURNAL OF CLINICAL MICROBIOLOGY & INFECTIOUS DISEASES,39(12).

Lin, Dachuan,et al."Evaluations of the serological test in the diagnosis of 2019 novel coronavirus (SARS-CoV-2) infections during the COVID-19 outbreak".EUROPEAN JOURNAL OF CLINICAL MICROBIOLOGY & INFECTIOUS DISEASES 39.12(2020).