Clinical validation of point-of-care SARS-COV-2 BD Veritor antigen test by a single throat swab for rapid COVID-19 status on hospital patients predominantly without overt COVID symptoms

  1. Jesper Bonde
  2. Ditte Ejegod
  3. Helle Pedersen
  4. Birgitte Smith
  5. Dina Cortes
  6. Cæcilie Leding
  7. Thorbjørn Thomsen
  8. Thomas Benfield
  9. Uffe Vest Schnieder
  10. Jens Tingleff
  11. Marc Arbyn
  12. Gorm Lisby
  13. Ove Andersen

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Abstract

BACKGROUND

Fast identification of severe acute respiratory syndrome Coronavirus-2 (SARS-CoV-2) infected individuals is a strategically vital task to ensure correct management and quarantine. Rapid antigen test could be a supplement to the standard-of-care Nucleic Acid Amplification Test (NAAT). The aim of this study was to determine the accuracy of the BD Veritor SARS-CoV-2 antigen test as a screening instrument in a hospital setting.

METHODS

A cohort of prospective samples were collected from hospital staff and patients at the Emergency, Infectious Diseases and Pediatrics and Adolescent Medicine departments at Hvidovre Hospital. All samples were collected using oropharyngeal swabs, and BD Veritor Antigen test results were paired with routine NAAT test results. Sensitivity, specificity, positive and negative predictive values of the antigen test were calculated using NAAT as reference.

RESULTS

Overall, 809 samples from 674 individuals were included (average age 45 years, range 0-98 years). Among all samples, 8% were SARS-CoV-2 positive by NAAT testing and 5.3% by BD Veritor. The sensitivity of the antigen test was 63.1% and specificity 99.7%. The positive predictive value was 95.3%. False-positive rate was 4%. The cycle threshold value was significantly higher among individuals with false negative antigen tests compared to true positives.

CONCLUSION

The sensitivity, specificity and positive predictive values show that the BD Veritor antigen test from oropharyngeal collected specimens performs well. Antigen testing may be a supplement, but not substitute, to NAAT testing as the primary diagnostic modality in hospital settings where fast turnaround test results may assist in decisions regarding isolation and quarantine.

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  1. ScreenIT

    SciScore for 10.1101/2021.04.12.21255299: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: Ethical approval: Unselected samples from in- and outpatients and staff constitute pilot implementation with embedded diagnostic quality development (Ethics Committee of the Capital Region of Denmark, record H-20080005).
    Randomizationnot detected.
    Blindingnot detected.
    Power AnalysisStatistical power: The cohort size was determined on >80% power to detect a 5% difference in sensitivity between PCR and the antigen POCT.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Software and Algorithms
    SentencesResources
    A box plot depicting the Cycle Threshold (Ct) scores between concordant and discordant PCR-to-Veritor samples (limited to Cobas FLOW and BGI results) were analyzed in GraphPad Prism version 9.
    GraphPad Prism
    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:
    Finally, the NPV of 97.6% is at par with the majority of antigen test evaluated6, with the caveat that high NPV values are driven by the relatively low SARS-CoV-2 prevalence in ours and other’s studies. Our study cohort is defined by all individuals being in- and outpatients at the Emergency-, Pediatrics- or Infectious Diseases departments and staff undergoing routine testing. The age range is from 5 days old to 98 years. The broad age spectrum contrast with similar studies, most of which only included persons 18 years or older (Table 3), demonstrating the easy operationalization of the Veritor antigen test using a throat collected specimen. The SARS-CoV-2 prevalence by NAAT, overall and amongst persons with unknown SARS-CoV-2 status, was 8.1% and 5.5%, respectively. The prevalence reflects the hospital setting, the enrichment with recently diagnosed, NAAT confirmed SARS-CoV-2 positive patients, and a peak prevalence of SARS-CoV-2 in Denmark at the time. Veritor test negative/PCR positive cases had significantly higher Ct scores indicating a lower viral load of the discordant samples compared to the Veritor-to-PCR concordant samples (Figure 2). This is in line with earlier studies of various antigen test system performance11-13,15-17. In the respiratory tract, SARS-CoV-2 peak viral load is observed at the time of symptom onset and subsequently declines18,19. In a clinical update by Cevik et al.20 they conclude that the highest infectiousness potential of SARS-CoV-2 is up to 5...

    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

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  2. Version published to 10.1101/2021.04.12.21255299v1 on medRxiv