Quidel Receives FDA EUA for First Rapid Antigen Combination ABC Test for Influenza A+B and COVID-19

Quidel Corporation (San Diego, CA, USA) has received Emergency Use Authorization (EUA) from the US Food and Drug Administration (FDA) to market its Sofia 2 Flu + SARS Antigen FIA.

The rapid point-of-care test is intended 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.

The 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. The Sofia 2 Flu + SARS Antigen FIA is currently available for sale in the US under EUA, and Quidel is now shipping the product to its customers.

“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.”

“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.”