Diasorin CE Marks New Simplexa Flu A/B & RSV Direct Gen II Assay to Run with Simplexa COVID-19 Direct Assay

DiaSorin Molecular LLC (Cypress, CA, USA) has CE marked its Simplexa Flu A/B & RSV Direct Gen II kit to run alongside its Simplexa COVID-19 Direct kit.

DiaSorin’s latest generation Simplexa Flu A/B & RSV Direct Gen II kit delivers continued comprehensive strain coverage and accurate detection in an efficient and trusted sample-to-answer format that does not require extraction. Collectively, over 100 Flu A, Flu B and 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.


The upcoming 2020/2021 flu season in the US will be complicated by the presence of SARS-CoV-2 also circulating in the community. Viral infections caused by Flu A, Flu B, RSV and SARS-CoV-2 have similar clinical presentations, although the treatment options are different, thus making it 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.

The Simplexa Flu A/B & RSV Direct Gen II assay provides flexibility in workflow management for the upcoming flu season as the assay can be run alone or alongside the Simplexa COVID-19 Direct kit. The assays are designed to be performed at the same time allowing for differential diagnosis of COVID-19, influenza, and RSV. DiaSorin has also submitted the new assay to the FDA for 510(k) clearance.

“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,” said 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.”