The Sofia 2 SARS Antigen+ FIA, with the Sofia 2 analyzer, provides automated and objective results in 10 minutes, allowing for COVID-19 testing of symptomatic patients when testing is started within 6 days of symptom onset. This test is intended for use as an aid in the diagnosis of SARS-CoV-2 infections in symptomatic individuals when either: tested at least twice over 3 days with at least 48 hours between tests; or when tested once, and negative by the Sofia 2 SARS Antigen+ FIA and followed up with a molecular test.