Qorvo Received EUA for Rapid COVID-19 Antigen Test

Qorvo Biotechnologies has received an updated Emergency Use Authorization (EUA) from the FDA for its Omnia SARS-CoV-2 antigen test for use in point-of-care settings.

The initial EUA in April 2021 had limited testing to moderate and high complexity settings such as laboratories. Now, the test can be used in physician offices, urgent care centers, retail pharmacies and for employee health testing.

The test is authorized for detection of antigens from the SARS-CoV-2 virus in nasal swab specimens from individuals who are suspected of COVID-19 within six days of symptom onset.

The test is also authorized for individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over three days, with at least 24 hours and no more than 48 hours between tests.