Thermo Fisher’s TaqPath COVID-19, Flu A, Flu B Combo Kit Granted FDA Emergency Use Authorization

(Waltham, MA, USA) has been granted emergency use authorization (EUA) by the US Food and Drug Administration (FDA) for the company’s Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit.

The TaqPath COVID-19, Flu A, Flu B Combo Kit is a real-time PCR test for the detection and differentiation of RNA from the SARS-CoV2, influenza A and influenza B viruses in nasopharyngeal and nasal swabs. The kit helps labs expand their existing COVID-19 testing menu for respiratory samples while maintaining low operational costs and workflow simplicity. The kit includes Applied Biosystems Pathogen Interpretive Software to automatically convert genetic analysis data into a readable report, helping reduce risk of user interpretation error.

"Understanding that the flu season would overlap with surges in COVID-19 infections, Thermo Fisher worked rapidly to develop a new multiplex real-time PCR diagnostic kit for detecting and differentiating SARS-CoV-2, influenza A and influenza B. These are illnesses which can present with similar clinical symptoms, but for which patient management, including quarantining measures, greatly differs," said Mark Smedley, president of Genetic Sciences for Thermo Fisher Scientific. Thermo Fisher. "This new kit offers clinical and public health laboratories a single test to help diagnose and monitor the spread of COVID-19 and the flu."