Development and evaluation of a new IgM/IgG rapid diagnostic test for SARS-CoV-2

  1. P.J. Ducrest

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Abstract

There is an urgent need in rapid diagnostic test (RDT) to detect antibodies against SARS-CoV-2. We have developed a rapid and simple point-of-care lateral flow immunoassay (LFIA) detecting IgM and IgG against SARS-CoV-2 in 10 minutes. The aim of this study is to evaluate the diagnostic performance of this RDT. RT-PCR positive plasma samples (n=35) for SARS-CoV-2 and 97 negative control samples were studied. Diagnostic performance of IgG/IgM RDT was assessed using both gold standard RT-PCR and Electro-chemiluminescence immunoassay (ECLIA) Elecsys ® Anti-SARS-CoV-2 total Ig. Overall, RDT sensitivity was 100% (95% confidence interval [95%CI]: 88-100%) and specificity 93% (95% CI: 85-97%). This IgG/IgM RDT done in plasma displays a high diagnostic accuracy for SARS-CoV-2 IgG/IgM in high COVID-19 prevalence settings. Its use could be considered in the absence of routine diagnostic serology facilities for samples collected between 10 and 180 days after symptoms onset.

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  1. ScreenIT

    SciScore for 10.1101/2020.10.09.20209866: (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
    If only the control line (C) appear, the sample does not contain IgM nor IgG antibodies.
    IgG
    suggested: None

    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:
    There are several limitations to this study. First, we present here the results of a method evaluation study and not a seroprevalence study. Therefore, the PPV obtained here (based on a 26.5% proportion of cases defined as laboratory confirmed SARS-CoV-2 by RT-PCR) will probably be lower in a low prevalence setting. Nevertheless, our results also showed that when targeting a population 10 days after symptoms onset, sensitivity and NPV reach high diagnostic performances (100%). Although not fully established here, we observed that the RDT results were consistent with the other automated serological test (ECLIA) with similar analytical sensitivity. Another limitation of this validation study lies in its limited sample size leading to broad 95% confidence intervals, requiring confirmation of these data at a larger scale. Finally, our present conclusions only apply to this RDT, and must not be applied to any other RDTs currently available. In conclusion, this RDT is not meant to replace a SARS-CoV-2 RT-PCR diagnostic test in the first week of the disease, but could be a reliable option for assessing the SARS-CoV-2 serology in moderate to high COVID-19 prevalence settings, especially in situations where automated ECLIA or ELISA are not available, with samples collected at least 10 days after symptoms onset and up to 180 days after the onset of symptoms. Further investigations in low prevalence situations and using capillary blood are necessary.

    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

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  2. Version published to 10.1101/2020.10.09.20209866 on medRxiv