Clinical Evaluation of BD Veritor SARS-CoV-2 Point-of-Care Test Performance Compared to PCR-Based Testing and versus the Sofia 2 SARS Antigen Point-of-Care Test

  1. Stephen Young
  2. Stephanie N. Taylor
  3. Catherine L. Cammarata
  4. Katey G. Varnado
  5. Celine Roger-Dalbert
  6. Amanda Montano
  7. Christen Griego-Fullbright
  8. Cameron Burgard
  9. Catherine Fernandez
  10. Karen Eckert
  11. Jeffrey C. Andrews
  12. Huimiao Ren
  13. Joseph Allen
  14. Ronald Ackerman
  15. Charles K. Cooper

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Abstract

The clinical performance of the BD Veritor System for Rapid Detection of SARS-CoV-2 nucleocapsid antigen (Veritor), a chromatographic immunoassay used for SARS-CoV-2 point-of-care testing, was evaluated using nasal specimens from individuals with COVID-19 symptoms. Two studies were completed to determine clinical performance. In the first study, nasal specimens and either nasopharyngeal or oropharyngeal specimens from 251 participants with COVID-19 symptoms (≤7 days from symptom onset [DSO], ≥18 years of age) were utilized to compare Veritor with the Lyra SARS-CoV-2 PCR assay (Lyra).

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  1. ScreenIT

    SciScore for 10.1101/2020.09.01.20185777: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementConsent: No study procedures were performed without an informed consent process or signature of a consent form.
    Randomizationnot detected.
    BlindingAll testing was conducted with all personnel blinded to all other test results.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    No key resources detected.

    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:
    Limitations: This study had some limitations. First, the Veritor test was performed on nasal swab specimens; however, the Lyra assay was performed on either NP (or OP) swab specimens per FDA-EUA requirements. Other EUA submissions (the LumiraDx SARS-CoV-2 Ag Test [“Luminar test”] and the Abbott BinaxNOW COVID-19 Ag CARD [“Abbott test”]) utilized nasal swab specimens for both the antigen test and the reference PCR assay. Furthermore, MAX from the remnant Veritor nasal swab in this report agreed with negative Veritor results in 7 of 9 discordant specimens. Improved PPA for Veritor versus Lyra may have been achieved through the use of paired nasal swab specimens in the EUA study. The Sofia 2 assay in study 2 was performed on nasal swabs that were collected either with (n=70; Table S4), or without (Table S5), a nose blowing step prior to collection. The nose-blowing step was an addition to the Sofia 2 test IFU intended only to reduce the frequency of invalid results (by reducing the amount of mucousal-, or blood-derived inhitors in the specimen), and was not included in order to alter the performance of the Sofia 2 test. Although the n is low for specimens with a pre-nose blowing step in study 2, here, the results suggest that the nose-blowing step did not alter the overall performance of the Sofia 2 test in relation to the Veritor test. Conclusions: The Veritor test met acceptance criteria for Emergency Use Authorization criteria for antigen testing (≥80% PPA point estimate) for...

    Results from TrialIdentifier: No clinical trial numbers were referenced.

    Results from Barzooka: We found bar graphs of continuous data. We recommend replacing bar graphs with more informative graphics, as many different datasets can lead to the same bar graph. The actual data may suggest different conclusions from the summary statistics. For more information, please see Weissgerber et al (2015).

    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.

  2. Version published to 10.1128/jcm.02338-20
  3. Version published to 10.1101/2020.09.01.20185777 on medRxiv