DiaSorin Simplexa COVID-19 & Flu A/B Assay receives U.S. FDA 510(k) clearance
DiaSorin announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Simplexa COVID-19 & Flu A/B Direct assay.
The test can detect and differentiate influenza A, influenza B, and SARS-CoV-2 viruses to help ensure physicians can recommend the most appropriate treatment for each patient.
The Simplexa COVID-19 & Flu A/B Direct assay offers clinical laboratories a sample-to-answer diagnostic workflow that enables them to generate actionable results efficiently, with minimal hands- on time. The test is a real-time RT-PCR assay performed using nasopharyngeal swab samples. Designed for use on the LIAISON MDX instrument, the assay detects viruses in a little more than an hour. No separate sample extraction or processing is required and one to eight samples can be tested at one time in a streamlined, simple workflow.
