• J. Med. Virol. · May 2021

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

    • L Courtellemont, J Guinard, C Guillaume, S Giaché, V Rzepecki, A Seve, C Gubavu, K Baud, C Le Helloco, G N Cassuto, G Pialoux, L Hocqueloux, and T Prazuck.
    • Department of Virology, CHR Orléans, Orléans, France.
    • J. Med. Virol. 2021 May 1; 93 (5): 3152-3157.

    AbstractThe 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.© 2021 Wiley Periodicals LLC.

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