VivaDiag™ SARS-CoV-2 Ag Rapid Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in nasal swabs or oropharyngeal swabs from individuals who are suspected of COVID-19. Results from nucleocapsid protein antigen testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 (COVID-19) infection or to inform infection status.