High performance of a novel antigen detection test on nasopharyngeal specimens for diagnosing SARS‐CoV‐2 infection

  1. L. Courtellemont
  2. J. Guinard
  3. C. Guillaume
  4. S. Giaché
  5. V. Rzepecki
  6. A. Seve
  7. C. Gubavu
  8. K. Baud
  9. C. Le Helloco
  10. G. N. Cassuto
  11. G. Pialoux
  12. L. Hocqueloux
  13. T. Prazuck

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Abstract

The severe acute respiratory syndrome coronavirus 2 (SARS‐CoV‐2) pandemic has become a major public health issue worldwide. Developing and evaluating rapid and easy‐to‐perform diagnostic tests is a high priority. The current study was designed to assess the diagnostic performance of an antigen‐based rapid detection test (COVID‐VIRO®) in a real‐life setting. Two nasopharyngeal specimens of symptomatic or asymptomatic adult patients hospitalized in the Infectious Diseases Department or voluntarily accessing the COVID‐19 Screening Department of the Regional Hospital of Orléans, France, were concurrently collected. The diagnostic specificity and sensitivity of COVID VIRO® results were compared to those of real‐time reverse‐transcriptase quantitative polymerase chain reaction (RT‐qPCR) results. A subset of patients underwent an additional oropharyngeal and/or saliva swab for rapid testing. A total of 121 patients confirmed to be infected and 127 patients having no evidence of recent or ongoing infection were enrolled for a total of 248 nasopharyngeal swab specimens. Overall, the COVID‐VIRO® sensitivity was 96.7% (CI, 93.5%–99.9%). In asymptomatic patients, symptomatic patients having symptoms for more than 4 days and those with an RT‐qPCR cycle threshold value ≥ 32, the sensitivities were 100%, 95.8%, and 91.9%, respectively. The concordance between RT‐qPCR and COVID VIRO® rapid test results was 100% for the 127 patients with no SARS‐CoV‐2 infection. The COVID‐VIRO® test had 100% specificity and sensitivity greater than 95%, which are better than the recommendations set forth by the WHO (specificity ≥ 97%–100%, sensitivity ≥ 80%). These rapid tests may be particularly useful for large‐scale screening in emergency departments, low‐resource settings, and airports.

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  1. ScreenIT

    SciScore for 10.1101/2020.10.28.20220657: (What is this?)

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

    Table 1: Rigor

    Institutional Review Board StatementIRB: Ethical approval: This study was approved by the Regional North West Ethics and Research Committee.
    Consent: A written informed consent was obtained from each participant.
    Randomizationnot detected.
    Blindingnot detected.
    Power Analysisnot detected.
    Sex as a biological variablenot detected.

    Table 2: Resources

    Antibodies
    SentencesResources
    Rapid antigen test: COVID-VIRO® (AAZ, Boulogne Billancourt, France) is a membrane-based immunochromatography assay detecting SARS-CoV-2 nucleocapsid antigen (N-protein) in nasopharyngeal samples through monoclonal antibodies.
    SARS-CoV-2 nucleocapsid antigen (N-protein
    suggested: None
    When nasopharyngeal secretions cross the strip, a passive diffusion allows the solubilized conjugate to migrate with the sample and react with the anti-SARS-CoV-2 antibodies immobilized on the membrane.
    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: We detected the following sentences addressing limitations in the study:
    This study has several limitations. First, this study is not a real-life study as when PCR positive patients came back for the study, the operators knew the status of the patient. Then, operators paid more attention to the results within 15 minutes. This method allows to give the real performances of the test done in the best conditions. This could be not the same in the real life, with many operators, emergencies ward where nurses will not necessary wait enough before reading or did not have the best conditions to read a thin line. Second, the date of symptoms onset was reported by patients and may not always be accurate, leading to an inaccurate stratification of patients. Then, the number of asymptomatic patients is rather limited to obtain conclusive data, even if we did not observe any discordance between tests in this group of patients. Finally, we did not perform any parallel comparison with other POCTs. In France, nurses, pharmaceuticals, and general practitioners have recently been authorized to perform POCTs in medical settings (7). Data obtained from the current study could reassure health authorities in expanding access to POCTs that, in addition to being quick and easy to use, are also reliable. In the current setting, positive unaware people could wait for RT-qPCR results for several days. During this time, they could easily infect their close contacts. A more rapid diagnosis and the subsequent contact tracing would certainly positively impact on the containment...

    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

    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 10.1002/jmv.26896
  3. Version published to 10.1101/2020.10.28.20220657 on medRxiv