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

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.