Evaluations of the serological test in the diagnosis of 2019 novel coronavirus (SARS-CoV-2) infections during the COVID-19 outbreak

  1. Dachuan Lin
  2. Lei Liu
  3. Mingxia Zhang
  4. Yunlong Hu
  5. Qianting Yang
  6. Jiubiao Guo
  7. Youchao Dai
  8. Yuzhong Xu
  9. Yi Cai
  10. Xinchun Chen
  11. Kaisong Huang
  12. Zheng Zhang

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Abstract

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  1. Version published to 10.1007/s10096-020-03978-6
  2. ScreenIT

    SciScore for 10.1101/2020.03.27.20045153: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: Verbal Informed consent was obtained from all individual participants.
    IRB: Ethical statement: The internal use of collected samples for diagnoses of etiological agents and serological research was approved by the Ethical Committee in the third people’s hospital of Shenzhen (SZTHEC2016001).
    RandomizationCOVID-19 patients were randomly enrolled from the third people’s hospital of Shenzhen, and their SARS-CoV-2 infections were confirmed by combinations of epidemiological risk, clinical features and positive detections of SARS-CoV-2 RNA in respiratory specimens using the National Medical Production Administration authorized GeneoDX kit according to the official instruction for diagnosis and treatment of 2019 novel coronavirus infections issued by the National Health Commission of the People’s Republic of China.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Detections of IgG and IgM by a commercial ELISA kit: In parallel testing, the commercial enzyme-linked immunosorbent assay kit (Darui Biotech, CHINA) for detections of the anti-SARS-CoV-2 IgG and IgM antibody was used to measure the SARS-CoV-2 antibody level in above mentioned COVID-19 patients and control individuals.
    anti-SARS-CoV-2 IgG
    suggested: None
    IgM
    suggested: None
    For the principle of this ELISA kit, the specific SARS-CoV-2 nucleocapsid protein and anti-human IgM monoclonal antibody were firstly coated on the plates, respectively.
    anti-human IgM
    suggested: None
    After five times washing by PBST buffer, the horseradish peroxidase (HRP) labeled mouse anti-human IgG antibody or HRP-labeled SARS-CoV-2 nucleocapsid antigen was added for 30 minutes incubation at 37 °C.
    anti-human IgG
    suggested: None
    Software and Algorithms
    SentencesResources
    Statistical analysis: All statistical analysis was performed in GraphPad Prism 7 software.
    GraphPad Prism
    suggested: (GraphPad Prism, RRID:SCR_002798)

    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.

  3. Version published to 10.1101/2020.03.27.20045153v1 on medRxiv