Group A Strep Molecular Test Delivers Definitive Results at POC in 15 Minutes

Strep throat is a bacterial infection caused by Group A Streptococcus (GAS). It is a leading bacterial cause of acute pharyngitis, particularly in children and adolescents, and one of the most common reasons for outpatient visits in pediatric, primary care, and urgent care settings. Because symptoms of streptococcal and viral pharyngitis frequently overlap, accurate and timely identification of GAS is critical to support appropriate patient management during the clinical encounter. Now, a GAP test is designed to deliver definitive molecular results at the point of care (POC) in approximately 15 minutes.

Diasorin’s (Saluggia, Italy) LIAISON NES Group A Strep test is designed to deliver definitive molecular results at the POC in approximately 15 minutes, enabling prompt diagnosis and timely treatment decisions. By providing a reliable answer in a single visit, the assay helps clinicians avoid diagnostic uncertainty and supports more appropriate antibiotic use without the delays associated with confirmatory laboratory testing.

Image: The LIAISON NES Group A Strep assay is intended for use on the LIAISON NES POC molecular diagnostics system (Photo courtesy of Diasorin)

Designed for use on the LIAISON NES POC molecular diagnostics system, the LIAISON NES Group A Strep assay provides clear, actionable results directly at the near-patient setting, improving efficiency and patient experience. This is in contrast to rapid antigen tests, which may require send-out molecular confirmation following negative results.

A key feature of the assay is its early call capability, which allows the system to identify and report positive results as soon as the presence of the pathogen is detected. This feature supports faster clinical decision-making and improved patient flow in busy outpatient environments.

Diasorin has submitted a 510(k) premarket notification and CLIA waiver application to the U.S. Food and Drug Administration (FDA) for its molecular assay for use on the LIAISON NES POC molecular diagnostics system. LIAISON NES Group A Strep is the second assay available on the group’s new molecular diagnostic POC platform, following the clearance of the LIAISON NES FLU A/B, RSV & COVID-19 assay.

“This submission reflects our continued execution and long-term commitment to the LIAISON NES platform,” said Angelo Rago, President of Luminex. “Following the recent FDA clearance of our first LIAISON NES FLU A/B, RSV & COVID-19 assay, we are already advancing the next test to expand clinical utility and reinforce the role of LIAISON NES as a credible, scalable molecular solution for decentralized care.”

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