Evaluation of Enzyme-Linked Immunoassay and Colloidal Gold-Immunochromatographic Assay Kit for Detection of Novel Coronavirus (SARS-Cov-2) Causing an Outbreak of Pneumonia (COVID-19)

  1. Jie Xiang
  2. Mingzhe Yan
  3. Hongze Li
  4. Ting Liu
  5. Chenyao Lin
  6. Shuang Huang
  7. Changxin Shen

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Abstract

BACKGROUND

In December 2019, a novel coronavirus (SARS-CoV-2)–infected pneumonia (COVID-19) occurred in Wuhan, China. Travel-associated cases have also been reported in other countries. The number of cases has increased rapidly but laboratory diagnosis is limited.

METHODS

We collect two groups of cases diagnosed with COVID-19 for experiments. One group collected 63 samples for Enzyme-linked immunosorbent assay (ELISA) IgG and IgM antibodies. The other group collected 91 plasma samples for colloidal gold-immunochromatographic assay (GICA).

RESULTS

The sensitivity of the combined ELISA IgM and ELISA IgG detection was 55/63 ( 87.3%), The sensitivity of the combined GICA IgM and GICA IgG detection was 75/91 ( 82.4%), Both methods are negative for healthy controls, specificity of 100%. There is no significant difference between the sensitivity of between ELISA and GICA (IgM+ IgG).

CONCLUSIONS

ELISA and GICA for specific IgM and IgG antibodies are conventional serological assays, they are simple, fast, and safe, the results can be used for clinical reference, and the huge clinical diagnosis and treatment pressure can be greatly relieved.

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  1. ScreenIT

    SciScore for 10.1101/2020.02.27.20028787: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: Study Design and Participants: This case series was approved by the institutional ethics board of Wuhan Jinyintan Hospital.
    Consent: Oral consent was obtained from patients.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    One group collected 63 samples from February 2, 2020 for Enzyme-linked immunosorbent assay (ELISA) IgG and IgM antibodies.
    IgM
    suggested: None
    ELISA: The novel coronavirus IgG/IgM antibody ELISA kits (lot number 2020010108) were manufactured by Zhu Hai Liv Zon Diagnostics Inc.
    coronavirus IgG/IgM
    suggested: None
    Then added 100 μL diluted samples to duplicate wells of microplates which were coated with mouse anti-human IgM monoclonal antibody (μchain), and incubated for 60 min at 37□±1□.
    anti-human IgM
    suggested: None
    Plates were washed five times and reacted with 100 μL enzyme marker (enzyme-labeled antibody-linked antigen) for 30 min at 37□±1°C for the purpose of detecting IgM against new coronavirus in serum samples.
    antibody-linked antigen
    suggested: None
    Software and Algorithms
    SentencesResources
    Statistical Analysis: All analyses were performed using SPSS 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.

  2. Version published to 10.1101/2020.02.27.20028787 on medRxiv