Immunological assays for SARS-CoV-2: an analysis of available commercial tests to measure antigen and antibodies

  1. John M. González
  2. William J. Shelton
  3. Manuel Díaz-Vallejo
  4. Victoria E. Rodriguez-Castellanos
  5. Juan Diego H. Zuluaga
  6. Diego F. Chamorro
  7. Daniel Arroyo-Ariza

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Abstract

The rapid spread of SARS-CoV-2 coronavirus infection has led to the development of molecular and serologic tests in a short period of time. While tests such as RT-PCR have applications in the immediate diagnosis revealing the presence of the virus, serological tests can be used to determine previous exposure to the virus and complement acute diagnosis. Antibody production can occur as early as 5 days post-infection. Both IgM and IgG specific anti-SARS-COV-2 antibodies can be a useful tool to test faster and larger groups of individuals. The objective of this study was to carry out a review of the different serological tests offered to detect antigen or antibodies against SARS-CoV-2. This information should be useful for decision takers in different countries to choose a test according to their needs. Based on web pages that listed serological assays, we found 226 coming from 20 countries, the majority are indirect tests for specific antibodies detection (n 180) and use immunochromatography methods (n 110) with samples coming from blood-derived products (n 105). Measuring IgM/IgG at the same time (n 112) and a procedure time of <20 min (n 83) are the most common. The overall average sensitivity was 91.8% and specificity was 97%. Most of the tests are currently for in vitro diagnosis (IVD). This information gathered could change day by day due to the expedite process of production and emergency of authorization use.

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  1. ScreenIT

    SciScore for 10.1101/2020.04.10.20061150: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    RandomizationData was randomly chosen to be verified by two authors.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Keywords used were: human + serology + either nCoV, SARS-CoV-2 and Covid-19 or human + antibodies + either nCoV, SARS-CoV-2.
    human +
    suggested: None
    SARS-CoV-2
    suggested: None
    We examined the articles, looking for ones that mentioned the use of commercial antigen or antibody detection kits.
    antigen
    suggested: None
    Software and Algorithms
    SentencesResources
    Two approaches were used for the literature search, web searches for pages listing serology tests for SARS-COv-2 and Pubmed (https://www.ncbi.nlm.nih.gov/pubmed/) for peer reviewed literature.
    https://www.ncbi.nlm.nih.gov/pubmed/
    suggested: (Europe PubMed Central, RRID:SCR_005901)
    A Pubmed search was conducted for articles describing studies of serology with human samples for SARS-CoV-2.
    Pubmed
    suggested: (PubMed, RRID:SCR_004846)

    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 10.1101/2020.04.10.20061150v1 on medRxiv
  3. Version published to 10.4236/oji.2020.102003