April 2, 2021 – Quidel Corporation (San Diego, CA) announced it has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA), allowing the company to market its Sofia SARS Antigen FIA for the detection of SARS-CoV-2 from nasal swab specimens from people who are within the first five days of symptoms, or are without symptoms or other epidemiological reasons to suspect COVID-19 tested twice over two (or three) days with at least 24 hours (and no more than 36 hours) between tests.
The company says that the easy-to-use test provides results in 15 minutes is available without a prescription.
Testing is limited to CLIA certified laboratories that meet the requirements to perform moderate, high, or waived complexity tests. This test is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
Quidel says that the Sofia SARS Antigen FIA shows excellent performance within the first five days of the onset of symptoms, with positive results agreeing with PCR 96.7% of the time, and negative results agreeing 100% of the time, “delivering confidence to physicians, healthcare workers and other customers within the professional segment.”
This new intended use allows the Sofia SARS Antigen FIA to be used among asymptomatic individuals and run without a prescription provided that individuals test twice within 24-36 hours.
Routine testing by rapid antigen tests has shown to be effective in diagnosing COVID-19, according to the company. As with all antigen tests, performance may decrease as days since symptom onset increases due to lower viral loads later in the patient’s disease course.
The Sofia SARS Antigen FIA is only for use under the Food and Drug Administration’s Emergency Use Authorization. The Sofia SARS Antigen FIA has not been FDA cleared or approved.