DALLAS – Quidel said late on Friday that it has received an Emergency Use Authorization (EUA) from the U.S. Food and Drug Administration (FDA) to market it’s 15-minute, influenza A, influenza B and COVID-19, also known as the “ABC Test”. This ABC test is a rapid point-of-care test to be used with the SOFIA2 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.
According to Quidel, the assay is the first rapid antigen test for detecting all three viruses simultaneously to receive EUA.
“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. It is essential for doctors to know what they’re dealing with quickly. We believe that our new ABC Test (Sofia® 2 Flu + SARS Antigen FIA) will help reduce misdiagnosis, inform proper treatment and improve disease surveillance, significantly enhancing medical effectiveness in fighting COVID-19 and the flu. We are proud to put this powerful diagnostic tool in the hands of physicians and public health agencies at this critical time.”
While symptoms of flu and COVID are similar, JAMA reports that treatments are different. Even in non-pandemic years, influenza is a serious public health concern. According to a recent report in ScienceAdvances, the flu and other causes of pneumonia are the eighth leading cause of death in the United States.
By enabling three tests to be performed simultaneously on a single cartridge using a single swab sample, the company can scale seasonal production of flu tests without impacting its scheduled ramp of COVID-19 antigen test capacity.
“This new three-way test to identify and separate influenza strains from coronavirus has arrived just in time for flu season. 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.”
