Thermo Fisher Scientific Announces 510(k) Clearance of Molecular Clinical Test for SARS-CoV-2, Flu A, Flu B and RSV

Thermo Fisher Scientific has received 510(k) clearance from the U.S. Food & Drug Administration (FDA) for the Applied Biosystems™ TaqPath™ COVID-19, Flu A, Flu B, RSV Select Panel, offering a single clinical testing solution for four of the most common respiratory viruses circulating in flu season. This real-time PCR-based multiplex test covers the detection and differentiation of SARS-CoV-2, influenza A virus, influenza B virus, and respiratory syncytial virus (RSV) and enables detection of co-infection.

Respiratory infections often present with overlapping signs of infection, making it difficult to accurately differentiate between common respiratory viral infections and therefore detect the specific pathogen responsible for the illness based on clinical presentation alone. Building on the proven reliability of Thermo Fisher’s COVID-19 test, the TaqPath COVID-19, Flu A, Flu B, RSV Select Panel enables detection and differentiation of common respiratory viruses in one patient sample. This helps clinicians get fast, accurate results in as little as three hours that enable them to make informed decisions on patient treatment.

“As we enter the height of flu season and rates of RSV continue to climb, the clearance of this test provides crucial support to clinical communities as they look for reliable and efficient testing solutions,” said Rosy Lee, President, Genetic Sciences.

 Key Applications:

• Reference/Clinical Laboratories

• Primary Care

• Infectious disease surveillance

Features:

Workflow simplicity: This solution includes a fully diagnostic workflow from sample extraction to results interpretation.

• Sample Prep: KingFisher™ Apex Dx system is designed to be a part of a streamlined modular workflow providing precise results, seamless data management, and robust security features per diagnostic regulatory standards.

• Sample Prep Reagents: Applied Biosystems MagMAX™ Dx Viral/Pathogen NA Isolation Kit to achieve high quality results using human respiratory biological specimens for qPCR downstream applications.

• PCR Instrument: Applied Biosystems QuantStudio™ 5 Dx Real-Time PCR System delivers proven performance and support to help meet the needs of clinical/hospital laboratories and test developers, in a compact footprint and cost-effective package.

• PRC Reagents: TaqPath™ COVID‑19, Flu A, Flu B, RSV Select Panel containing assay for SARS-CoV-2, Flu A, Flu B, RSV detection, Positive and Negative controls, 1 Step Master Mix and an internal RNaseP endogenous control for human sample collection QC.

• Results Analysis: Applied Biosystems Diomni Enterprise Software v4.1 is an on-premise workflow solution that connects all steps in your real-time PCR (qPCR) test development and routine testing workflows with one single ecosystem.