Evaluation of nine commercial SARS-CoV-2 immunoassays

  1. Ria Lassaunière
  2. Anders Frische
  3. Zitta B. Harboe
  4. Alex C.Y. Nielsen
  5. Anders Fomsgaard
  6. Karen A. Krogfelt
  7. Charlotte S. Jørgensen

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Abstract

Due to urgency and demand, numerous severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) immunoassays are rapidly being developed and placed on the market with limited validation on clinical samples. Thorough validation of serological tests are required to facilitate their use in the accurate diagnosis of SARS-CoV-2 infection, confirmation of molecular results, contact tracing, and epidemiological studies. This study evaluated the sensitivity and specificity of nine commercially available serological tests. These included three enzyme-linked immunosorbent assays (ELISAs) and six point-of-care (POC) lateral flow tests. The assays were validated using serum samples from: i) SARS-CoV-2 PCR-positive patients with a documented first day of disease; ii) archived sera obtained from healthy individuals before the emergence of SARS-CoV-2 in China; iii) sera from patients with acute viral respiratory tract infections caused by other coronaviruses or non-coronaviruses; and iv) sera from patients positive for dengue virus, cytomegalovirus and Epstein Barr virus. The results showed 100% specificity for the Wantai SARS-CoV-2 Total Antibody ELISA, 93% for the Euroimmun IgA ELISA, and 96% for the Euroimmun IgG ELISA with sensitivities of 90%, 90%, and 65%, respectively. The overall performance of the POC tests according to manufacturer were in the rank order of AutoBio Diagnostics > Dynamiker Biotechnology = CTK Biotech > Artron Laboratories > Acro Biotech ≥ Hangzhou Alltest Biotech. Overall, these findings will facilitate selection of serological assays for the detection SARS-CoV-2-specific antibodies towards diagnosis as well as sero-epidemiological and vaccine development studies.

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  1. ScreenIT

    SciScore for 10.1101/2020.04.09.20056325: (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
    The assay is based on a double-antigen sandwich principle that detects total antibodies binding SARS-CoV-2 spike protein receptor binding domain (RBD) in human serum or plasma.
    SARS-CoV-2 spike protein receptor binding domain ( RBD
    suggested: None
    In two separate semi-quantitative ELISAs, either IgA or IgG antibodies against SARS-CoV-2 spike protein subunit 1 (S1) are detected in human serum or plasma.
    IgA
    suggested: None
    SARS-CoV-2 spike protein subunit 1
    suggested: None
    Point-of-care (POC) tests: Six POC tests for rapid detection of antibodies in blood, serum or plasma were evaluated: 2019-nCOV IgG/IgM Rapid Test (Dynamiker Biotechnology, Tianjin, China Cat # DNK-1419-1), OnSiteTM COVID-19 IgG/IgM Rapid Test (CTK Biotech, Poway, CA, USA; Cat # R0180C), Anti-SARS-CoV-2 Rapid Test (AutoBio Diagnostics, Zhengzhou
    2019-nCOV IgG/IgM Rapid Test ( Dynamiker Biotechnology , Tianjin ,
    suggested: None
    Anti-SARS-CoV-2
    suggested: None
    , Coronavirus Diseases 2019 (COVID-19) IgM/IgG Antibody Test (Artron Laboratories, Burnaby, Canada; Cat # A03-51-322), 2019-nCoV IgG/IgM Rapid Test Cassette (Acro Biotech, Rancho Cucamonga, CA, USA; Cat # INCP-402), and 2019-nCoV IgG/IgM Rapid Test Cassette (Hangzhou Alltest Biotech, Hangzhou, China; Cat # INCP-402).
    2019-nCoV IgG/IgM
    suggested: None
    Software and Algorithms
    SentencesResources
    The clinical accuracies of the ELISA assays were examined by using Receiver Operator Characteristic (ROC) plots with GraphPad Prism version 8.0.2 (GraphPad Software, San Diego, CA, USA).
    GraphPad Prism
    suggested: (GraphPad Prism, RRID:SCR_002798)
    GraphPad
    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.

  2. Version published to 10.1101/2020.04.09.20056325v1 on medRxiv