Quidel has received the US Food and Drug Administration (FDA) Emergency Use Authorisation (EUA) for its Sofia 2 Flu + SARS Antigen FIA, a rapid point-of-care diagnostic test.
The new test is designed for rapid, simultaneous qualitative detection and differentiation of the nucleocapsid protein antigens from SARS-CoV-2, influenza A and influenza B, when used with the Sofia 2 Fluorescent Immunoassay Analyser.
The test uses 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.
Quidel Corporation president and CEO Douglas Bryant said: “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,” Bryant concluded. “We are proud to put this powerful diagnostic tool in the hands of physicians and public health agencies at this critical time.”
Sofia 2 Flu + SARS Antigen FIA provides results in 15 minutes
The company said that its new Sofia 2 Flu + SARS Antigen FIA is designed to provide enhanced performance for SARS-2, Influenza A and Influenza B in nasal swabs.
The new Sofia test is designed to deliver a fast, accurate result for all three viruses from one nasal swab sample in just 15 minutes.
The new ABC Test marks the first diagnostic test to offer both flu and SARS diagnostic technologies in a single test cartridge, which the company can manufacture on the same infrastructure used for Sofia SARS tests.
Under the EUA, the company is currently commercialising its Sofia 2 Flu + SARS Antigen FIA in the US, and is shipping the test to its customers.
AdvaMedDx, an advocacy organisation dedicated to serve diagnostic manufacturers in the US and abroad, commented on the new test, saying that ‘the Game-changing testing device from Quidel will save lives heading into flu season’.
Quidel is a member company of AdvaMed and AdvaMedDx.
AdvaMedDx executive director Susan Van Meter said: “Quidel’s rapid ABC test, which can be deployed nearly anywhere health care providers care for patients, is a critical new tool broadening the ecosystem of the COVID tests commercial manufacturers are delivering at scale to protect patients and public health.”
