Accuracy of rapid point-of-care antibody test in patients with suspected or confirmed COVID-19

  1. Rama Vancheeswaran
  2. Merlin Luke Willcox
  3. Beth Stuart
  4. Matthew Knight
  5. Hala Kandil
  6. Andrew Barlow
  7. Mayon Haresh Patel
  8. Jade Stockham
  9. Aisling O'Neill
  10. Tristan W Clark
  11. Tom Wilkinson
  12. Paul Little
  13. Nick Francis
  14. Gareth Griffiths
  15. Michael Moore

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Abstract

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  1. Version published to 10.1016/j.jinf.2021.07.006
  2. ScreenIT

    SciScore for 10.1101/2020.11.17.20233296: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: In both cases we included only adults (age 18 and over), at least 7 days after onset of symptoms, and who gave written informed consent.
    IRB: Analysis: Ethical approvals: This study was approved by the Faculty of Medicine Research Ethics Committee at the University of Southampton (reference 56480) and by the Wales Research Ethics Committee 4 (Wrexham, IRAS 283264, REC 20/WA/0148).
    Randomizationnot detected.
    Blindingnot detected.
    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:
    Strengths and weaknesses of the study: This study was conducted in a true “point-of-care” setting, not using laboratory samples. This shows that the test had good diagnostic test accuracy when used in a routine clinical setting. We included a good balance of patients, both admitted to hospital and never seen in hospital, which also makes the findings more widely generalisable. All participants had clinical symptoms of COVID-19, and there is information about the course of their illness which enables us to examine diagnostic accuracy in different subgroups. However, while it is possible to provide a “gold standard” in laboratory settings using stored sera, this is not possible in a clinical setting as there is no “gold standard” which is 100% sensitive and specific in clinical practice. According to official documentation, the overall sensitivity of the reference venous antibody test is 83.9% overall, 86.1% at or after 14 days, or 86.7% at or after 21 days of symptom onset7. Our own data confirms that compared to PCR, the reference antibody test was 89.2% sensitive. Although a positive PCR can be used as a gold standard to determine sensitivity, the PCR itself is not 100% sensitive and cannot be used as a “gold standard” for determining specificity11. However, a strength of our study is that many of our participants had both a PCR test and a venous antibody test; using these in combination improves the accuracy of the reference standard. As the POC test was conducted by clinic...

    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.

  3. Version published to 10.1101/2020.11.17.20233296 on medRxiv