Qorvo announced Thursday that the U.S. Food and Drug Administration (FDA) has granted Emergency Use Authorization (EUA) for its Omnia SARS-CoV-2 Antigen Test in point-of-care settings.
The test is authorized for the detection of nucleocapsid viral antigens from COVID-19 in nasal swab specimens taken within six days of symptom onset from those who are suspected of having COVID-19.
Individuals without symptoms or for whom there are other epidemiological reasons to suspect COVID-19 may also use the product to test twice over three days, with at least 24 hours and no more than 48 hours between tests.
The EUA expands the market for Qorvo beyond laboratories to include physicians' offices, urgent care centers, retail pharmacies, employee health testing, and any other locations where CLIA-waived tests can be performed, Qorvo said.
