DiaSorin Molecular, Cypress, Calif, has CE marked its Simplexa Flu A/B and RSV Direct Gen II kit. DiaSorin Molecular’s latest generation Simplexa Flu A/B and RSV Direct Gen II kit delivers continued comprehensive strain coverage and accurate detection in an efficient sample-to-answer format that does not require extraction. Collectively, more than 100 Flu A, Flu B, and respiratory syncytial virus (RSV) strains have been validated, including the 2020/2021 influenza vaccine strains. The Simplexa Flu A/B & RSV Direct Gen II assay is designed for use with the Liaison MDX instrument.
Michelle Tabb, DiaSorin Molecular.
The upcoming 2020/2021 flu season will be complicated by the continued presence of SARS-CoV-2. Viral infections caused by Flu A, Flu B, RSV, and SARS-CoV-2 have similar clinical presentations; however, treatment options are different and thus it is important to differentiate. Additionally, co-infection with SARS-CoV-2 and influenza A or B has been shown to cause increased severity of respiratory disease and the need for a combination therapy. The accurate diagnosis of the virus causing the infection can have major implications for the management of therapeutic regimens, infection control, and community mitigation efforts.
“We met our goal to have the Simplexa Flu A/B & RSV Direct Gen II assay available in time for use during the upcoming flu season and for patient samples to be tested, when needed, alongside the covid-19 direct assay,” says Michelle Tabb, chief scientific officer of DiaSorin Molecular. “This flu season the ability to detect and differentiate between influenza, RSV, and covid-19 will be vital and we are pleased to contribute to this solution.”
DiaSorin Molecular has also submitted the new assay to the FDA for 510(k) clearance.
For more information, visit DiaSorin Molecular.
