Performance of Gazelle COVID-19 point-of-care test for detection of nucleocapsid antigen from SARS-CoV-2

  1. Amrish Mehta
  2. Bri Spencer
  3. Ashok Garg
  4. Pradeep Kalmorge
  5. Raúl A. Ocasio Gonzalez
  6. Kate Taussig
  7. Ryan R. Fortna

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Abstract

SARS-CoV-2 antigen assays offer simplicity and rapidity in diagnosing COVID-19. We assessed the clinical performance of Gazelle COVID-19 test, a fluorescent lateral flow immunoassay with an accompanying Reader utilizing image-recognition software for detection of nucleocapsid antigen from SARS-CoV-2. We performed a prospective, operator-blinded, observational study at 2 point-of-care (POC) sites. Nasal swab specimens from symptomatic patients were tested with Gazelle COVID-19 test and real-time polymerase chain reaction (RT-P CR) assay. Overall, data from 1524 subjects was analyzed, and 133 were positive by RT-PCR. Mean (range) age of participants was 34.7 (2-94) years and 570 (37.4%) were female. The sensitivity and the specificity of the Gazelle COVID-19 test were 96.3% and 99.7%. The PPV of Gazelle COVID-19 test was 97.0%, NPV 99.6%, and accuracy 99.4%. In POC settings, Gazelle COVID-19 test had high diagnostic accuracy for detection of SARS-CoV-2 in nasal swab samples of symptomatic subjects suspected of COVID-19.

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  1. ScreenIT

    SciScore for 10.1101/2022.03.23.22272094: (What is this?)

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

    Table 1: Rigor

    EthicsConsent: All consecutive patients who visited the facilities for a Covid test and who met inclusion criteria were enrolled in the study and informed consent was obtained.
    Sex as a biological variablenot detected.
    Randomizationnot detected.
    BlindingOperators of the Gazelle COVID-19 Test and the RT-PCR test were blinded to the results on the different test platform.
    Power Analysisnot 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:
    This study has some limitations. subjects with invalid results were not able to be retested because participants left the facility before test results were available. A total of 2.6% of the initial Gazelle Covid-19 test results were either invalid or canceled and would have required patient retesting in accordance with the IFU. Re-collection of samples and retesting would be expected to further reduce the invalid rate, but this was not possible during our study. Discrepant results observed between the Gazelle Covid-19 test and reference RT-PCR could not be further clarified, as further samples were not available for retesting. In summary, herein we have shown that the Gazelle Covid-19 test using a nasal swab collection method is highly accurate and has close concordance with RT-PCR based assay for detection of SARS-CoV-2 in a POC setting. Gazelle Covid-19 test has potential to quickly and effectively screen all symptomatic patients suspected of COVID-19 at POC, enabling rapid detection and isolation of people most likely to pose an infectious risk.

    Results from TrialIdentifier: We found the following clinical trial numbers in your paper:

    IdentifierStatusTitle
    NCT04987918Not yet recruitingGazelle COVID-19 Test Clinical Accuracy Protocol

    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.

  2. Version published to 10.1101/2022.03.23.22272094v1 on medRxiv