DiaSorin received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for its Simplexa COVID & 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, according to the company. It is important for physicians to understand which virus or viruses—whether its COVID and/or influenza—are present in order to select therapies and recommend the most appropriate management plan, such as isolation strategies.

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.

This test adds to the existing FDA-cleared menu of molecular assays used to diagnose the most common respiratory infections during the winter season (SimplexaTM Flu A/B & RSV Direct Gen II) and during the COVID pandemic (SimplexaTM COVID-19 Direct), and will secure long-term options to labs after the Emergency Use Authorization (EUA) period has ended, enabling implementation of diagnostic algorithms based on specific lab and/or seasonal needs.

“We are pleased to expand our menu of FDA-cleared tests for customers using the LIAISON MDX instrument and to provide increased flexibility in workflow and test offerings to help labs respond to seasonal changes in test demand,” says Angelo Rago, president of Luminex. “By pairing flu and COVID-19 testing in one easy-to-use, rapid molecular assay, we hope to ease the burden on clinical labs that would otherwise have to run multiple tests for each patient to get complete answers.”

This project has been funded in whole or in part with federal funds from the Department of Health and Human Services; Administration for Strategic Preparedness and Response; Biomedical Advanced Research and Development Authority, under contract number 75A50121P00007.

Featured image: The assay is designed for use on the LIAISON MDX instrument. Photo: DiaSorin