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Quidel’s Sofia® SARS Antigen Test Receives Emergency Use Authorization for Screening Use With Serial Testing
Easy-to-use test that provides results in 15 minutes is now available without a prescription SAN DIEGO--(BUSINESS WIRE)-- Quidel Corporation (NASDAQ: QDEL)
About this update from Quidelortho Corporation
[{"type":"text","content":"\nEasy-to-use test that provides results in 15 minutes is now available without a prescription\n\n SAN DIEGO--(BUSINESS WIRE)--\nQuidel Corporation (NASDAQ: QDEL) (“Quidel”), a leading provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that 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 qualitative detection of the nucleocapsid protein antigen from SARS-CoV-2 from anterior nares swab specimens directly from individuals who are either suspected of COVID-19 by their healthcare provider within the first five days of the onset of symptoms, or are individuals 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. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, 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.\n\nThe 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-19.1 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. Similarly, the inability to synchronize asymptomatic individuals with onset of infection may impact performance as specimens may be tested when viral loads are below the assay’s limit of detection. Clinical studies in asymptomatic patients undergoing serial testing ...