Evaluation of a new “all in one” SARS‐CoV‐2 antigen‐detecting rapid diagnostic test and self‐test: Diagnostic performance and usability in child and adult populations

  1. Thierry Prazuck
  2. Anne Gravier
  3. Daniela Pires‐Roteira
  4. Aurelie Theillay
  5. Sandra Pallay
  6. Mathilda Colin
  7. Raphael Serreau
  8. Laurent Hocqueloux
  9. Nino Guy Cassuto

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Abstract

The control of the COVID‐19 epidemics has been one global health priorities for the last 2 years. To that end, more reliable and easy‐to‐use, regardless of age, diagnostic tests are necessary. Considering that, we evaluated an innovative two‐step self‐test, the AAZ COVID‐VIRO ALL IN®, switching from the classic nasal swab to a nasal sponge. We performed a multicenter study, on 124 adults and children, in a point‐of‐care setting. Sensitivity, specificity and overall acceptance of the COVID‐VIRO ALL IN® self‐test compared to reverse transcriptase polymerase chain reaction (RT‐PCR) on nasopharyngeal samples were of 93.0%, 100%, and 97.5%, respectively. We then performed a multicenter, usability study to evaluate the ease of use of COVID‐VIRO ALL IN® on 68 laypersons adults. A vast majority of participants correctly executed and interpreted the test. The usability was then specifically investigated on 40 children and teenagers, comparing COVID‐VIRO® first generation to the new COVID‐VIRO ALL IN®. They all found COVID‐VIRO ALL IN® more comfortable and easier to use. For young children, the new self‐test seems safer (less risk of trauma and no liquid exposure), and faster than saliva‐based RT‐PCR. Moreover, the COVID‐VIRO ALL IN® can easily be adapted as a multiplex self‐test for other respiratory viruses, opening new perspectives of simultaneous, rapid and massive detection of respiratory infections, especially among vulnerable populations like children and elderly people.

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  1. Version published to 10.1002/jmv.27812
  2. ScreenIT

    SciScore for 10.1101/2021.09.14.21263403: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The study was evaluated and approved by the French ethics committee (Comité de Protection des Personnes Nord-Ouest IV) in October 2020 and was notified to the French data protection authority.
    Consent: This implies that all participants provided written informed consent before undergoing any study-specific procedure.
    Sex as a biological variablenot detected.
    Randomization2.3.2.2 Interpretation of test results: The usability study also included a test result interpretation exercise during which the observer instructed the participant to randomly select 1 of 4 contrived self-tests (1 negative, 2 positive and 1 invalid), read it and give his/her interpretation of the result.
    Blindingnot detected.
    Power Analysisnot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    In the test, SARS-CoV-2 antigens in the sample interact with monoclonal anti-SARS-CoV-2 antibodies to form a coloured antibody-antigen complex.
    anti-SARS-CoV-2
    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: An explicit section about the limitations of the techniques employed in this study was not found. We encourage authors to address study limitations.

    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 10.1101/2021.09.14.21263403v1 on medRxiv