Clinical Evaluation of a Point-of-Care (POC), COVID-19 Rapid Antigen Test (CoviDx™)

Inclusion Criteria: * Nasopharyngeal swab collected for SARS-CoV-2 RT-PCR with EUA as per standard of care within 3 hours of CoviDx Rapid Antigen Swab collection * First onset of COVID-19-like symptoms within the last 5 days * ≥ 1 year of age * Signed Informed Consent Exclusion Criteria: * Unable or unwilling to provide signed, Informed Consent * Less than 1 year of age * SARS-Cov-2 RT-PCR collection that occurred \> 3 hours from CoviDx Rapid Antigen Swab collection * First onset of COVID-19-like symptoms occurring more than 5 days from study visit * Invalid or missing PCR test results * Use of a non-high-sensitive SARS-CoV-2 test as the qualifying SARS-CoV-2 RT-PCR test (e.g., Abbott ID NOW, rapid antigen tests, tests that do not have FDA EUA, a test that was not approved by Sponsor for use in the study) * Enrollment in another study involving the collection of a nasopharyngeal or nasal swab * Receipt of a COVID-19 vaccine or participation in a COVID-19 vaccine study