DiaSorin Molecular CE Marks their new Simplexa™ COVID-19 & Flu A/B Direct Assay for Detection and Differentiation of SARS-CoV-2 and Influenza in One Test.
Cypress, Calif. (September 20, 2021) – DiaSorin Molecular LLC announced today that it has CE marked its Simplexa™ COVID-19 & Flu A/B Direct kit. The multiplex test allows for the in vitro qualitative detection and differentiation of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), influenza A virus and influenza B virus from the same patient sample in one reaction well. The assay is designed for use on the LIAISON® MDX and is run directly from nasopharyngeal swabs (NPS) without the need for off board extraction. The kit will also be submitted to the FDA for 510(k) review.