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Evaluations of the serological test in the diagnosis of 2019 novel coronavirus (SARS-CoV-2) infections during the COVID-19 outbreak.
Eur J Clin Microbiol Infect Dis. 2020 Dec; 39(12):2271-2277.EJ

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.

Authors+Show Affiliations

Guangdong Provincial Key Laboratory of Regional Immunity and Disease, Department of Pathogen Biology, School of Medicine, Shenzhen University, Shenzhen, China.National Clinical Research Center for Infectious Diseases, Guangdong Key Lab for Diagnosis &Treatment of Emerging Infectious Diseases, Shenzhen Third People's Hospital, Southern University of Science and Technology, Shenzhen, China.National Clinical Research Center for Infectious Diseases, Guangdong Key Lab for Diagnosis &Treatment of Emerging Infectious Diseases, Shenzhen Third People's Hospital, Southern University of Science and Technology, Shenzhen, China.Guangdong Provincial Key Laboratory of Regional Immunity and Disease, Department of Pathogen Biology, School of Medicine, Shenzhen University, Shenzhen, China.National Clinical Research Center for Infectious Diseases, Guangdong Key Lab for Diagnosis &Treatment of Emerging Infectious Diseases, Shenzhen Third People's Hospital, Southern University of Science and Technology, Shenzhen, China.Guangdong Provincial Key Laboratory of Regional Immunity and Disease, Department of Pathogen Biology, School of Medicine, Shenzhen University, Shenzhen, China.Guangdong Provincial Key Laboratory of Regional Immunity and Disease, Department of Pathogen Biology, School of Medicine, Shenzhen University, Shenzhen, China.Department of Clinical Laboratory, Shenzhen Baoan People's Hospital, The Second Affiliated Hospital of Shenzhen University, Shenzhen, China.Guangdong Provincial Key Laboratory of Regional Immunity and Disease, Department of Pathogen Biology, School of Medicine, Shenzhen University, Shenzhen, China.Guangdong Provincial Key Laboratory of Regional Immunity and Disease, Department of Pathogen Biology, School of Medicine, Shenzhen University, Shenzhen, China.Guangdong Provincial Key Laboratory of Regional Immunity and Disease, Department of Pathogen Biology, School of Medicine, Shenzhen University, Shenzhen, China. kaisong@szu.edu.cn.National Clinical Research Center for Infectious Diseases, Guangdong Key Lab for Diagnosis &Treatment of Emerging Infectious Diseases, Shenzhen Third People's Hospital, Southern University of Science and Technology, Shenzhen, China. zhangzheng1975@aliyun.com.

Pub Type(s)

Journal Article

Language

eng

PubMed ID

32681308

Citation

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 : Official Publication of the European Society of Clinical Microbiology, vol. 39, no. 12, 2020, pp. 2271-2277.
Lin D, Liu L, Zhang M, et al. Evaluations of the serological test in the diagnosis of 2019 novel coronavirus (SARS-CoV-2) infections during the COVID-19 outbreak. Eur J Clin Microbiol Infect Dis. 2020;39(12):2271-2277.
Lin, D., Liu, L., Zhang, M., Hu, Y., Yang, Q., Guo, J., Dai, Y., Xu, Y., Cai, Y., Chen, X., Huang, K., & Zhang, Z. (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 : Official Publication of the European Society of Clinical Microbiology, 39(12), 2271-2277. https://doi.org/10.1007/s10096-020-03978-6
Lin D, et al. Evaluations of the Serological Test in the Diagnosis of 2019 Novel Coronavirus (SARS-CoV-2) Infections During the COVID-19 Outbreak. Eur J Clin Microbiol Infect Dis. 2020;39(12):2271-2277. PubMed PMID: 32681308.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluations of the serological test in the diagnosis of 2019 novel coronavirus (SARS-CoV-2) infections during the COVID-19 outbreak. AU - Lin,Dachuan, AU - Liu,Lei, AU - Zhang,Mingxia, AU - Hu,Yunlong, AU - Yang,Qianting, AU - Guo,Jiubiao, AU - Dai,Youchao, AU - Xu,Yuzhong, AU - Cai,Yi, AU - Chen,Xinchun, AU - Huang,Kaisong, AU - Zhang,Zheng, Y1 - 2020/07/17/ PY - 2020/04/22/received PY - 2020/07/02/accepted PY - 2020/7/19/pubmed PY - 2020/11/26/medline PY - 2020/7/19/entrez KW - Chemiluminescence immunoassay KW - IgM and IgG KW - SARS-CoV-2 KW - Serological testing SP - 2271 EP - 2277 JF - European journal of clinical microbiology & infectious diseases : official publication of the European Society of Clinical Microbiology JO - Eur J Clin Microbiol Infect Dis VL - 39 IS - 12 N2 - 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. SN - 1435-4373 UR - https://www.unboundmedicine.com/medline/citation/32681308/Evaluations_of_the_serological_test_in_the_diagnosis_of_2019_novel_coronavirus__SARS_CoV_2__infections_during_the_COVID_19_outbreak_ DB - PRIME DP - Unbound Medicine ER -