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Evaluation of Nucleocapsid and Spike Protein-Based Enzyme-Linked Immunosorbent Assays for Detecting Antibodies against SARS-CoV-2.
J Clin Microbiol. 2020 05 26; 58(6)JC

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.

Authors+Show Affiliations

Department of Transfusion, General Hospital of Central Theater Command of the People's Liberation Army, Wuhan, Hubei, China.Department of Transfusion, General Hospital of Central Theater Command of the People's Liberation Army, Wuhan, Hubei, China.Department of Transfusion, General Hospital of Central Theater Command of the People's Liberation Army, Wuhan, Hubei, China.Department of Transfusion, General Hospital of Central Theater Command of the People's Liberation Army, Wuhan, Hubei, China.Department of Transfusion, General Hospital of Central Theater Command of the People's Liberation Army, Wuhan, Hubei, China.Department of Transfusion, General Hospital of Central Theater Command of the People's Liberation Army, Wuhan, Hubei, China.Department of Disease Control and Prevention, General Hospital of Central Theater Command of the People's Liberation Army, Wuhan, Hubei, China.Department of Disease Control and Prevention, General Hospital of Central Theater Command of the People's Liberation Army, Wuhan, Hubei, China.Department of Transfusion, General Hospital of Central Theater Command of the People's Liberation Army, Wuhan, Hubei, China.Department of Transfusion, General Hospital of Central Theater Command of the People's Liberation Army, Wuhan, Hubei, China.Department of Transfusion, General Hospital of Central Theater Command of the People's Liberation Army, Wuhan, Hubei, China.Department of Transfusion, General Hospital of Central Theater Command of the People's Liberation Army, Wuhan, Hubei, China sxkzsg@sina.com.

Pub Type(s)

Evaluation Study
Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

32229605

Citation

Liu, Wanbing, et al. "Evaluation of Nucleocapsid and Spike Protein-Based Enzyme-Linked Immunosorbent Assays for Detecting Antibodies Against SARS-CoV-2." Journal of Clinical Microbiology, vol. 58, no. 6, 2020.
Liu W, Liu L, Kou G, et al. Evaluation of Nucleocapsid and Spike Protein-Based Enzyme-Linked Immunosorbent Assays for Detecting Antibodies against SARS-CoV-2. J Clin Microbiol. 2020;58(6).
Liu, W., Liu, L., Kou, G., Zheng, Y., Ding, Y., Ni, W., Wang, Q., Tan, L., Wu, W., Tang, S., Xiong, Z., & Zheng, S. (2020). Evaluation of Nucleocapsid and Spike Protein-Based Enzyme-Linked Immunosorbent Assays for Detecting Antibodies against SARS-CoV-2. Journal of Clinical Microbiology, 58(6). https://doi.org/10.1128/JCM.00461-20
Liu W, et al. Evaluation of Nucleocapsid and Spike Protein-Based Enzyme-Linked Immunosorbent Assays for Detecting Antibodies Against SARS-CoV-2. J Clin Microbiol. 2020 05 26;58(6) PubMed PMID: 32229605.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Evaluation of Nucleocapsid and Spike Protein-Based Enzyme-Linked Immunosorbent Assays for Detecting Antibodies against SARS-CoV-2. AU - Liu,Wanbing, AU - Liu,Lei, AU - Kou,Guomei, AU - Zheng,Yaqiong, AU - Ding,Yinjuan, AU - Ni,Wenxu, AU - Wang,Qiongshu, AU - Tan,Li, AU - Wu,Wanlei, AU - Tang,Shi, AU - Xiong,Zhou, AU - Zheng,Shangen, Y1 - 2020/05/26/ PY - 2020/03/10/received PY - 2020/03/28/accepted PY - 2020/4/2/pubmed PY - 2020/6/2/medline PY - 2020/4/2/entrez KW - COVID-19 diagnosis KW - ELISA KW - IgG KW - IgM KW - antibody KW - nucleocapsid protein KW - spike protein JF - Journal of clinical microbiology JO - J Clin Microbiol VL - 58 IS - 6 N2 - 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. SN - 1098-660X UR - https://www.unboundmedicine.com/medline/citation/32229605/Evaluation_of_Nucleocapsid_and_Spike_Protein_Based_Enzyme_Linked_Immunosorbent_Assays_for_Detecting_Antibodies_against_SARS_CoV_2_ L2 - http://jcm.asm.org/cgi/pmidlookup?view=long&pmid=32229605 DB - PRIME DP - Unbound Medicine ER -