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

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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.

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  1. SciScore for 10.1101/2020.03.16.20035014: (What is this?)

    Please note, not all rigor criteria are appropriate for all manuscripts.

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    This study was approved by the Hospital Ethics Committee of the General Hospital of the Central Theater Command of the PLA ([2020]003-1) and the written informed consent was waived for emerging infectious diseases. rN-based ELISA: The recombinant nucleocapsid (rN) protein-based ELISA kit (Lizhu, Zhuhai, China) was used for the detection of IgM or IgG antibody against SARS-CoV-2.
    SARS-CoV-2
    suggested: None
    For IgM detection, ELISA plates were coated with monoclonal mouse anti-human IgM (μ chain) antibody.
    anti-human IgM (μ chain)
    suggested: None
    After incubation and washing, HRP-conjugated monoclonal mouse anti-human IgG antibody was added to the plates for detection.
    anti-human IgG
    suggested: None
    After five wash steps with washing buffer, 100 μL of diluted HRP-conjugated anti-human IgM antibodies was added to the wells, and samples were incubated at 37 °C for 30 min.
    anti-human IgM
    suggested: None
    Software and Algorithms
    SentencesResources
    Statistical analyses were performed using SPSS version 22.0.
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    Results from OddPub: We did not detect open data. We also did not detect open code. Researchers are encouraged to share open data when possible (see Nature blog).


    Results from LimitationRecognizer: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    Results from TrialIdentifier: No clinical trial numbers were referenced.


    Results from Barzooka: We did not find any issues relating to the usage of bar graphs.


    Results from JetFighter: We did not find any issues relating to colormaps.


    Results from rtransparent:
    • Thank you for including a conflict of interest statement. Authors are encouraged to include this statement when submitting to a journal.
    • Thank you for including a funding statement. Authors are encouraged to include this statement when submitting to a journal.
    • No protocol registration statement was detected.

    About SciScore

    SciScore is an automated tool that is designed to assist expert reviewers by finding and presenting formulaic information scattered throughout a paper in a standard, easy to digest format. SciScore checks for the presence and correctness of RRIDs (research resource identifiers), and for rigor criteria such as sex and investigator blinding. For details on the theoretical underpinning of rigor criteria and the tools shown here, including references cited, please follow this link.