Real-life performance of a COVID-19 rapid antigen detection test targeting the SARS-CoV-2 nucleoprotein for diagnosis of COVID-19 due to the Omicron variant

  1. Paula de Michelena
  2. Ignacio Torres
  3. Ángela Ramos-García
  4. Victoria Gozalbes
  5. Nidia Ruiz
  6. Ana Sanmartín
  7. Pilar Botija
  8. Sandrine Poujois
  9. Dixie Huntley
  10. Eliseo Albert
  11. David Navarro

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Abstract

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  1. Version published to 10.1016/j.jinf.2022.02.022
  2. ScreenIT

    SciScore for 10.1101/2022.02.02.22270295: (What is this?)

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

    Table 1: Rigor

    EthicsIRB: The study was approved by the Hospital Clínico de Valencia (HCU) INCLIVA Research Ethics Committee.
    Consent: Since the testing strategy was considered as regular clinical practice according to local health authorities, written informed consent was waived by this committee.
    Field Sample Permit: RT-PCRs were carried out within 24 h of specimen collection with the TaqPath COVID-19 Combo Kit (Thermo Fisher Scientific, MS, USA) which targets SARS-CoV-2 ORF1ab, N and S genes.
    Sex as a biological variablePatients: In the current observational prospective study, a convenience sample of 244 patients (median age, 40 years; range 2–96; 141 female) with clinical suspicion of COVID-19, 232 of whom were adults (median age, 41 years; range, 17–96) and 12 children (median age, 15 years; range, 2–16), attending three randomly selected primary care centers affiliated to the Clínico-Malvarrosa Health Department in Valencia (Spain) were recruited between January 10 and January 21.
    RandomizationPatients: In the current observational prospective study, a convenience sample of 244 patients (median age, 40 years; range 2–96; 141 female) with clinical suspicion of COVID-19, 232 of whom were adults (median age, 41 years; range, 17–96) and 12 children (median age, 15 years; range, 2–16), attending three randomly selected primary care centers affiliated to the Clínico-Malvarrosa Health Department in Valencia (Spain) were recruited between January 10 and January 21.
    Blindingnot detected.
    Power Analysisnot detected.
    Cell Line AuthenticationAuthentication: The S-gene dropout RT-PCR profile was systematically associated with the Omicron variant within the study period, as confirmed by whole-genome sequencing (not shown).

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    Statistical analyses were performed using SPSS version 25.0 (SPSS, Chicago, IL, USA).
    SPSS
    suggested: (SPSS, RRID:SCR_002865)

    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:
    The limitations of the current study are as follows. First, Omicron subvariant B.1.529.2 (BA.2 ), which lacks the 69-70 deletion, may be incorrectly categorized as such based on the SGTF result; nonetheless, this subvariant could not be identified in sequenced specimens within the study period in our health department. Second, side-by-side clinical performance comparison of the RADT for diagnosis of COVID-19 due to Omicron and other variants of concern was not possible due to the absolute dominance of the former at the time of study. Third, no cell cultures were performed for specimens returning discordant RT-PCR/RADT results. Fourth, the small number of children, SARS-CoV-2-experienced and unvaccinated individuals enrolled precluded conducting robust subanalyses for these population groups. In summary, we found the Panbio™ COVID-19 Ag Rapid Test Device to perform well as a point-of-care test for early diagnosis of COVID-19 due to the Omicron variant in primary healthcare centers. Further studies are warranted to evaluate the performance of this and other RADT for detection of Omicron variant infection in asymptomatic, pediatric and unvaccinated individuals.

    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 10.1101/2022.02.02.22270295 on medRxiv