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Journal of Clinical Microbiology
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Immunoassays

Evaluation of Nucleocapsid and Spike Protein-Based Enzyme-Linked Immunosorbent Assays for Detecting Antibodies against SARS-CoV-2

Wanbing Liu, Lei Liu, Guomei Kou, Yaqiong Zheng, Yinjuan Ding, Wenxu Ni, Qiongshu Wang, Li Tan, Wanlei Wu, Shi Tang, Zhou Xiong, Shangen Zheng
Alexander J. McAdam, Editor
Wanbing Liu
aDepartment of Transfusion, General Hospital of Central Theater Command of the People’s Liberation Army, Wuhan, Hubei, China
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Lei Liu
aDepartment of Transfusion, General Hospital of Central Theater Command of the People’s Liberation Army, Wuhan, Hubei, China
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Guomei Kou
aDepartment of Transfusion, General Hospital of Central Theater Command of the People’s Liberation Army, Wuhan, Hubei, China
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Yaqiong Zheng
aDepartment of Transfusion, General Hospital of Central Theater Command of the People’s Liberation Army, Wuhan, Hubei, China
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Yinjuan Ding
aDepartment of Transfusion, General Hospital of Central Theater Command of the People’s Liberation Army, Wuhan, Hubei, China
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Wenxu Ni
aDepartment of Transfusion, General Hospital of Central Theater Command of the People’s Liberation Army, Wuhan, Hubei, China
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Qiongshu Wang
bDepartment of Disease Control and Prevention, General Hospital of Central Theater Command of the People’s Liberation Army, Wuhan, Hubei, China
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Li Tan
bDepartment of Disease Control and Prevention, General Hospital of Central Theater Command of the People’s Liberation Army, Wuhan, Hubei, China
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Wanlei Wu
aDepartment of Transfusion, General Hospital of Central Theater Command of the People’s Liberation Army, Wuhan, Hubei, China
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Shi Tang
aDepartment of Transfusion, General Hospital of Central Theater Command of the People’s Liberation Army, Wuhan, Hubei, China
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Zhou Xiong
aDepartment of Transfusion, General Hospital of Central Theater Command of the People’s Liberation Army, Wuhan, Hubei, China
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Shangen Zheng
aDepartment of Transfusion, General Hospital of Central Theater Command of the People’s Liberation Army, Wuhan, Hubei, China
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Alexander J. McAdam
Boston Children's Hospital
Roles: Editor
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DOI: 10.1128/JCM.00461-20
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ABSTRACT

At present, PCR-based nucleic acid detection cannot meet the demands for coronavirus infectious disease (COVID-19) diagnosis. Two hundred fourteen confirmed COVID-19 patients who were hospitalized in the General Hospital of Central Theater Command of the People’s Liberation Army between 18 January and 26 February 2020 were recruited. Two enzyme-linked immunosorbent assay (ELISA) kits based on recombinant severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleocapsid protein (rN) and spike protein (rS) were used for detecting IgM and IgG antibodies, and their diagnostic feasibility was evaluated. Among the 214 patients, 146 (68.2%) and 150 (70.1%) were successfully diagnosed with the rN-based IgM and IgG ELISAs, respectively; 165 (77.1%) and 159 (74.3%) were successfully diagnosed with the rS-based IgM and IgG ELISAs, respectively. The positive rates of the rN-based and rS-based ELISAs for antibody (IgM and/or IgG) detection were 80.4% and 82.2%, respectively. The sensitivity of the rS-based ELISA for IgM detection was significantly higher than that of the rN-based ELISA. We observed an increase in the positive rate for IgM and IgG with an increasing number of days post-disease onset (d.p.o.), but the positive rate of IgM dropped after 35 d.p.o. The positive rate of rN-based and rS-based IgM and IgG ELISAs was less than 60% during the early stage of the illness, 0 to 10 d.p.o., and that of IgM and IgG was obviously increased after 10 d.p.o. ELISA has a high sensitivity, especially for the detection of serum samples from patients after 10 d.p.o., so it could be an important supplementary method for COVID-19 diagnosis.

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Evaluation of Nucleocapsid and Spike Protein-Based Enzyme-Linked Immunosorbent Assays for Detecting Antibodies against SARS-CoV-2
Wanbing Liu, Lei Liu, Guomei Kou, Yaqiong Zheng, Yinjuan Ding, Wenxu Ni, Qiongshu Wang, Li Tan, Wanlei Wu, Shi Tang, Zhou Xiong, Shangen Zheng
Journal of Clinical Microbiology May 2020, 58 (6) e00461-20; DOI: 10.1128/JCM.00461-20

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Evaluation of Nucleocapsid and Spike Protein-Based Enzyme-Linked Immunosorbent Assays for Detecting Antibodies against SARS-CoV-2
Wanbing Liu, Lei Liu, Guomei Kou, Yaqiong Zheng, Yinjuan Ding, Wenxu Ni, Qiongshu Wang, Li Tan, Wanlei Wu, Shi Tang, Zhou Xiong, Shangen Zheng
Journal of Clinical Microbiology May 2020, 58 (6) e00461-20; DOI: 10.1128/JCM.00461-20
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KEYWORDS

COVID-19 diagnosis
ELISA
IgG
IgM
antibody
nucleocapsid protein
spike protein

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