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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.
Lin, Dachuan; Liu, Lei; Zhang, Mingxia; Hu, Yunlong; Yang, Qianting; Guo, Jiubiao; Dai, Youchao; Xu, Yuzhong; Cai, Yi; Chen, Xinchun; Huang, Kaisong; Zhang, Zheng.
  • Lin D; Guangdong Provincial Key Laboratory of Regional Immunity and Disease, Department of Pathogen Biology, School of Medicine, Shenzhen University, Shenzhen, China.
  • Liu L; 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.
  • Zhang M; 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.
  • Hu Y; Guangdong Provincial Key Laboratory of Regional Immunity and Disease, Department of Pathogen Biology, School of Medicine, Shenzhen University, Shenzhen, China.
  • Yang Q; 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.
  • Guo J; Guangdong Provincial Key Laboratory of Regional Immunity and Disease, Department of Pathogen Biology, School of Medicine, Shenzhen University, Shenzhen, China.
  • Dai Y; Guangdong Provincial Key Laboratory of Regional Immunity and Disease, Department of Pathogen Biology, School of Medicine, Shenzhen University, Shenzhen, China.
  • Xu Y; Department of Clinical Laboratory, Shenzhen Baoan People's Hospital, The Second Affiliated Hospital of Shenzhen University, Shenzhen, China.
  • Cai Y; Guangdong Provincial Key Laboratory of Regional Immunity and Disease, Department of Pathogen Biology, School of Medicine, Shenzhen University, Shenzhen, China.
  • Chen X; Guangdong Provincial Key Laboratory of Regional Immunity and Disease, Department of Pathogen Biology, School of Medicine, Shenzhen University, Shenzhen, China.
  • Huang K; Guangdong Provincial Key Laboratory of Regional Immunity and Disease, Department of Pathogen Biology, School of Medicine, Shenzhen University, Shenzhen, China. kaisong@szu.edu.cn.
  • Zhang Z; 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.
Eur J Clin Microbiol Infect Dis ; 39(12): 2271-2277, 2020 Dec.
Article in English | MEDLINE | ID: covidwho-652076
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.
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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Clinical Laboratory Techniques / Nucleocapsid Proteins / Pandemics / Betacoronavirus / Luminescent Measurements / Antibodies, Viral Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Country/Region as subject: Asia Language: English Journal: Eur J Clin Microbiol Infect Dis Journal subject: Communicable Diseases / Microbiology Year: 2020 Document Type: Article Affiliation country: S10096-020-03978-6

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Pneumonia, Viral / Coronavirus Infections / Clinical Laboratory Techniques / Nucleocapsid Proteins / Pandemics / Betacoronavirus / Luminescent Measurements / Antibodies, Viral Type of study: Cohort study / Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Adolescent / Adult / Aged / Female / Humans / Male / Middle aged Country/Region as subject: Asia Language: English Journal: Eur J Clin Microbiol Infect Dis Journal subject: Communicable Diseases / Microbiology Year: 2020 Document Type: Article Affiliation country: S10096-020-03978-6