Performance of a rapid antigen test for SARS-CoV-2 in Kenya

  1. Simon N. Onsongo
  2. Kephas Otieno
  3. Shannen van Duijn
  4. Emily Adams
  5. Mervis Omollo
  6. Isdora A. Odero
  7. Alloys K'Oloo
  8. Nathalie Houben
  9. Emmanuel Milimo
  10. Robert Aroka
  11. Hellen C. Barsosio
  12. Fredrick Oluoch
  13. Albert Odhiambo
  14. Simon Kariuki
  15. Tobias F. Rinke de Wit

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Abstract

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  1. Version published to 10.1016/j.diagmicrobio.2021.115591
  2. ScreenIT

    SciScore for 10.1101/2021.08.12.21261462: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: We obtained informed consent for all eligible adults and assent and parental consent for eligible minors below 18 years.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Cell Line AuthenticationAuthentication: Samples having exponential growth curve and Ct < 40 in at least two SARS-CoV-2 targets were considered positive, while those with Ct values in only one target were inconclusive.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistical analysis: Analyses were performed using STATA-15 (StataCorp LLC, Texas, USA) and Microsoft Excel (
    StataCorp
    suggested: (Stata, RRID:SCR_012763)
    Microsoft Excel
    suggested: (Microsoft Excel, RRID:SCR_016137)
    Ag-RDT sensitivity, specificity, positive likelihood ratio, negative likelihood ratio, positive predictive value, negative predictive value, and accuracy were calculated using MedCalc online software calculator20, grouped according to Ct values using the following cut-offs: 25, 30, 35 and 40
    MedCalc
    suggested: (MedCalc, RRID:SCR_015044)

    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:
    Though helpful, the limitations of these kits should be noted by the users. Some studies have suggested low sensitivity in screening asymptomatic patients 29,31,32. Various authors have cited lower sensitivity in patients with low viral load (high Ct values on RT-PCR); hence RT-PCR testing should continue to be offered where clinical suspicion is high24,30,33. The users should follow manufacturers laid down testing procedures to avoid potentially misleading false-negative or false-positive results.

    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.

    Results from scite Reference Check: We found no unreliable references.

    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 10.1101/2021.08.12.21261462v1 on medRxiv