Diagnostic accuracy of the FebriDx host response point-of-care test in patients hospitalised with suspected COVID-19

  1. Tristan W. Clark
  2. Nathan J Brendish
  3. Stephen Poole
  4. Vasanth V. Naidu
  5. Christopher Mansbridge
  6. Nicholas Norton
  7. Helen Wheeler
  8. Laura Presland
  9. Sean Ewings

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Abstract

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  1. Version published to 10.1016/j.jinf.2020.06.051
  2. ScreenIT

    SciScore for 10.1101/2020.05.27.20114512: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: The study was approved by the South Central - Hampshire A Research Ethics Committee: REC reference 20/SC/0138, on the 16th March 2020.
    Randomizationnot detected.
    BlindingThe results of the FebriDx were not shared with the clinical teams and the readers of the FebriDx test lines were blinded to the PCR results (FebriDx results were read and recorded before PCR results were available).
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    No key resources detected.

    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 the generalisability of our study. As the study was performed in almost exclusively immunocompetent adults the results cannot be applied to immune-compromised patients or to children and separate evaluations should be urgently undertaken in these important patient groups. In addition the findings of our study cannot be extrapolated to community dwelling patients including those who are infected but asymptomatic or pauci-symptomatic, as it uncertain whether their antiviral host response would be comparable to hospitalised patients. The diagnostic accuracy of FebriDx reported in this study is in the context of a very high disease prevalence and as we have shown the performance characteristics will change as the disease prevalence drops, with implications for how the test could be used. In particular the positive predictive value will decrease now that the first wave is subsiding, although the negative predictive value will increase further meaning that a negative FebriDx will remain a useful rule-out test. As MxA detection is a marker of antiviral host response and is not specific for COVID-19, the calculated test specificity will be lower when other viruses such as influenza are circulating. As early identification of influenza alongside COVID-19 will remains vitally important in hospitals, a rapid triage tool that detects both influenza and COVID-19 is likely to be of utility in the coming winter months. Finally, as this was a single centre st...

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    ISRCTN14966673NANA

    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.

  3. Version published to 10.1101/2020.05.27.20114512 on medRxiv