Severe acute respiratory syndrome-associated coronavirus IVDs

Intended purpose

Intended to detect the novel coronavirus SARS-CoV-2 at the point of care by trained health professionals (nasopharyngeal and nasal swabs) from individuals who meet COVID-19 clinical and / or epidemiological criteria and for self-testing by lay persons (nasal swabs) to aid in the diagnosis of an active SARS-COV-2 infection.