510k clearance for Diasorin Simplexa COVID-19, Flu A/B, and RSV kit
The kit as broad coverage for influenza strains, emerging SARS-CoV-2 variants, and detection of both RSV subgroups A and B
7 Nov 2025
Diasorin has announced that it has received 510(k) clearance from the U.S. Food and Drug Administration (FDA) for the Simplexa COVID-19 / Flu A/B & RSV Direct kit, a sample-to-answer test for the detection of SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) directly from nasopharyngeal and nasal swab specimens.
Designed for use on the LIAISON® MDX system, the assay is suitable for both hospital and commercial laboratories, enabling timely and highly accurate differential diagnosis of the four primary respiratory viruses circulating during the winter season.
Following the COVID-19 pandemic, a resurgence of both influenza virus and RSV, particularly evident since the 2022/2023 season, has underscored the need to detect these pathogens, along with SARS-CoV-2, during peak infection periods. The Simplexa COVID-19 / Flu A/B & RSV Direct kit addresses this need by providing a streamlined solution that delivers accurate and simultaneous detection in a single assay.
The rapid differential detection of four targets in approximately 45 minutes reflects a significant advancement in Simplexa technology on the LIAISON MDX platform, that achieves increased multiplexing capabilities and enhanced speed. This comprehensive approach enhances the accuracy of respiratory illness diagnosis, which is critical for effective therapeutic management and infection control, especially when clinical presentations alone can be ambiguous.
By providing a clearer and more complete understanding of a patient’s condition, the test enables healthcare providers to tailor treatment plans more effectively, leading to improved patient outcomes and minimizing unnecessary treatments, making this the test of choice for the respiratory season.
"We are excited to introduce our new 4-plex test enabling detection of SARS-CoV-2, influenza A and B, and RSV, designed to meet the demands of today’s respiratory testing landscape," said Angelo Rago, President of Luminex. "Our dedication to offering adaptable testing solutions is reflected in the addition of this 4-plex kit to our comprehensive range of COVID-19 and flu testing assays, ensuring that laboratories are equipped to handle dynamic respiratory seasons and evolving healthcare environments."
