Clinical performance evaluation of SARS-CoV-2 rapid antigen testing in point of care usage in comparison to RT-qPCR

  1. Isabell Wagenhäuser
  2. Kerstin Knies
  3. Vera Rauschenberger
  4. Michael Eisenmann
  5. Miriam McDonogh
  6. Nils Petri
  7. Oliver Andres
  8. Sven Flemming
  9. Micha Gawlik
  10. Michael Papsdorf
  11. Regina Taurines
  12. Hartmut Böhm
  13. Johannes Forster
  14. Dirk Weismann
  15. Benedikt Weißbrich
  16. Lars Dölken
  17. Johannes Liese
  18. Oliver Kurzai
  19. Ulrich Vogel
  20. Manuel Krone

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Abstract

No abstract available

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  1. Version published to 10.1016/j.ebiom.2021.103455
  2. ScreenIT

    SciScore for 10.1101/2021.03.27.21253966: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: Ethical approval: The Ethics committee of the University of Wuerzburg waived the need to formally apply for ethical clearance due to the study design (File No. 20210112 01).
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistics: Data analysis was performed using Excel® 2019 (Microsoft, Redmond WA, USA), SPSS Statistics 26 (IBM, Armonk NY, USA), and GraphPad Prism (GraphPad Software, San Diego CA, USA).
    SPSS
    suggested: (SPSS, RRID:SCR_002865)
    GraphPad Prism
    suggested: (GraphPad Prism, RRID:SCR_002798)
    GraphPad
    suggested: (GraphPad Prism, RRID:SCR_002798)

    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 has several limitations. For each participant was assessed only by one of the three chosen RDT, and therefore different RDT only compared indirectly. Moreover, the distribution of the three RDT was inhomogeneous throughout the different clinical departments. Each of these also has an individual patient structure. Despite this, our data represents in vivo experience with RDTs in a large cohort. The low incidence of SARS-CoV-2 in our study setting limits the number of RT-qPCR positive persons in the study but reflects a realistic scenario of present and future RDT use. The performance of RDTs in other spike protein variants cannot be assessed as they were not determined in the study population. Given the targets of the assays, however, spike protein mutations are unlikely to affect RDT-detection.

    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

    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 10.1101/2021.03.27.21253966v1 on medRxiv