July 9, 2020—DiaSorin Molecular announced that its Simplexa Flu A/B & RSV Direct Gen II kit has received the CE mark. The kit delivers continued comprehensive strain coverage and accurate detection in a sample-to-answer format that does not require extraction.
Designed for use with the Liaison MDX instrument, the Simplexa Flu A/B & RSV Direct Gen II 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.
“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,” Michelle Tabb, chief scientific officer of DiaSorin Molecular, said in a press statement. “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 has submitted the assay for 510(k) clearance.