Comparative evaluation of six immunoassays for the detection of antibodies against SARS-CoV-2

  1. Felipe Pérez-García
  2. Ramón Pérez-Tanoira
  3. María Esther Iglesias
  4. Juan Romanyk
  5. Teresa Arroyo
  6. Peña Gómez-Herruz
  7. Rosa González
  8. Sara Lapeña García
  9. Juan Cuadros-González

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Abstract

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  1. ScreenIT

    SciScore for 10.1101/2020.09.08.20190488: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board Statementnot detected.
    RandomizationWe included two groups of patients: Negative controls: 60 serum samples from a randomly selected group of patients who the sample taken for other serologic studies, from September 1 to November 30, 2019.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Serological assays: LFAs: we evaluated one LFA which detects IgG and IgM antibodies against SARS-CoV-2 nucleocapsid (AllTest COVID-19 IgG/IgM [AllTest Biotech, Hangzhou, China]) and two LFAs which detect IgG and IgM antibodies against nucleocapsid and spike ( One Step Rapid Test [Innovita Biological Technology, Hebei, China] and SeroFlash SARS-CoV-2 IgM/IgG [Epigentek Group, New York, USA]).
    IgM antibodies against nucleocapsid and spike ( One Step Rapid Test [Innovita Biological Technology, Hebei, China]
    suggested: None
    ELISA: we evaluated one ELISA which detects IgG and IgM antibodies against nucleocapsid and spike (Dia.
    IgM antibodies against nucleocapsid and spike (Dia.
    suggested: None
    CLIA: we evaluated two CLIAs for total antibodies (IgM+IgG): Elecsys Anti-SARS-CoV-2 (Roche Diagnostics, Mannheim, Germany), which detects antibodies against nucleocapsid and SARS-CoV-2 Total COV2T (Siemens Healthineers, Erlangen, Germany), which detects antibodies against spike (S1).
    Anti-SARS-CoV-2
    suggested: None
    S1
    suggested: None
    Software and Algorithms
    SentencesResources
    Statistical analysis was performed using Stata/IC 13.1 (StataCorp, Texas, USA).
    StataCorp
    suggested: (Stata, RRID:SCR_012763)

    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: We detected the following sentences addressing limitations in the study:
    Our study presents some limitations. First, it is a retrospective study that has been conducted in a single institution. Further prospective multicenter studies are necessary to reinforce our findings. Second, sensitivity evaluation of CLIAs was performed only over 50 sera, due to insufficient simple volume. However, the samples that could not be analyzed belonged to the first two weeks after the onset of symptoms. As a consequence, this limitation did not affect the results about sensitivity from 14 days, when the vast majority of patients seroconvert according to different studies [10,12,18]. Finally, we have analyzed the results of six among all commercialized immunoassays. Consequently, our results should not be extrapolated to other available immunoassays and more comparative studies and meta-analysis are needed to establish the usefulness of other serologic tests. In conclusion, One Step LFA, Dia.Pro ELISA and Elecsys and COV2T CLIAs present the best diagnostic performance results. All these techniques showed a specificity of 100% and sensitivities over 97% from 14 days after the onset of symptoms, as well as excellent levels of agreement between them. To our knowledge, this study constitutes the first comparative evaluation of these six immunoassays. These findings indicate that these tests could be reliable tools for the diagnosis of COVID-19 and the performance of epidemiological studies.

    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.
    • Thank you for including a protocol registration statement.

    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 10.1016/j.jviromet.2020.114047
  3. Version published to 10.1101/2020.09.08.20190488v1 on medRxiv