The BD Veritor System for Rapid Detection of SARS-CoV-2 is a rapid (approximately 15 minutes) chromatographic digital immunoassay for the direct detection of the presence or absence SARS-CoV-2 antigens in respiratory specimens taken from patients with signs and symptoms who are suspected of COVD-19. Results are for the identification of SARS-CoV-2 nucleocapsid antigen. This antigen is generally detectable in upper respiratory samples during the acute phase of infection. Positive results indicate the presence of viral antigens, but clinical correlation with patient history and other diagnostic information is necessary to determine infection status. The test is intended for interpretation in both laboratory and near patient testing environments only with the BD Veritor Plus Analyzer Instrument. The test is not intended to be interpreted visually. Procedures to evaluate test devices depend on the BD Veritor Plus Analyzer workflow configuration chosen.