DiaSorin has received U.S. approval for its Simplexa Flu A/B & RSV Direct Gen II kit, which can be used to differentiate between cases of influenza and COVID-19.

The Italian company announced clearance by the Food and Drug Administration on Tuesday.

The new test can be run alone or alongside the Simplexa COVID-19 Direct kit, allowing for differential diagnosis of SARS-CoV-2, influenza A, influenza B and respiratory syncytial virus, or RSV.

Viral infections caused by the flu, RSV and SARS-CoV-2 have similar clinical presentations but different treatment options. Co-infection with COVID-19 and the flu has been shown to cause increased severity of respiratory disease.

Industry experts have warned the coming flu season will be unprecedented due to the coronavirus crisis multiplying worries. 

“With COVID-19 set to play a major role in the upcoming flu season, it was critical for us to have the Simplexa Flu A/B & RSV Direct Gen II assay available in time for patient samples to be tested, when needed, alongside the Simplexa COVID-19 Direct assay,” said Michelle Tabb, chief scientific officer of DiaSorin Molecular. “Detection and differential diagnosis between influenza, RSV and COVID-19 will be vital this year and we are pleased to contribute to this solution.”

Accurate diagnosis could have major implications for therapeutic management, infection control and mitigation. The Simplexa Flu A/B & RSV kit is built on more than 100 validated flu A, flu B and RSV strains, including the 2020/2021 influenza vaccine strains.

DiaSorin is an immunodiagnostic specialist, with research and development focused on infectious diseases, bone metabolism, hormones and GI stool testing.