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Quidel Receives Emergency Authorization for First Rapid Antigen “ABC Test”: A Combination Diagnostic Assay for Influenza A+B and COVID-19
Sofia® 2 Flu + SARS Antigen FIA point-of-care test delivers 3 results from 1 sample in 15 minutes ABC Test comes “just in time” as coronavirus pandemic and
About this update from Quidelortho Corporation
[{"type":"text","content":"\nSofia® 2 Flu + SARS Antigen FIA point-of-care test delivers 3 results from 1 sample in 15 minutes \n\nABC Test comes “just in time” as coronavirus pandemic and flu season converge\n\n SAN DIEGO--(BUSINESS WIRE)--\nQuidel Corporation (NASDAQ: QDEL) (“Quidel”), a provider of rapid diagnostic testing solutions, cellular-based virology assays and molecular diagnostic systems, announced today that Quidel has received Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to market its Sofia® 2 Flu + SARS Antigen FIA, a rapid point-of-care test to be used with the Sofia® 2 Fluorescent Immunoassay Analyzer for the rapid, simultaneous qualitative detection and differentiation of the nucleocapsid protein antigens from SARS-CoV-2, influenza A and influenza B in direct nasopharyngeal (NP) and nasal (NS) swab specimens from individuals suspected of respiratory viral infection consistent with COVID-19 by their healthcare provider within the first five days of the onset of symptoms.\n\nThe new Sofia® 2 Flu + SARS Antigen FIA offers excellent performance for SARS-2 (95.2% PPA versus PCR and 100% NPA versus PCR), as well as for Influenza A (90% sensitivity versus culture and 95% specificity versus culture) and Influenza B (89% sensitivity versus culture and 96% specificity versus culture) in nasal swabs. Quidel’s new Sofia® test delivers a fast, highly accurate result for all three viruses from one nasal swab (or nasopharyngeal swab) sample in just 15 minutes, providing critical answers to patients and healthcare workers alike.\n\n“As the COVID-19 pandemic converges with seasonal influenza, public health experts face the potential for a ‘perfect storm’ of patients exhibiting similar but distinct medical conditions that require different treatment methods,” said Douglas Bryant, president and CEO of Quidel Corporation. “It is essential for doctors to know what they’re dealing with quickly.”\n\n“This new three-way test to identify and separate influenza strains from coronavirus has arrived just in time for flu season,” said Dr. John Fallon, Medical Director, Vidant Healthcare System. “Quidel has achieved a diagnostic breakthrough that will save time, resources and lives. This is welcome news for healthcare providers already under immense strain from COVID-19 and facing the added challenge of virulent influenza.”\n\nQu...