COVID-19, Flu A, Flu B Combo Kit Granted EUA by FDA

Thermo Fisher Scientific, an analytical laboratory instrument manufacturing company, has been granted an emergency use authorization (EUA) by the US Food and Drug administration (FDA) for a coronavirus disease 2019 (COVID-19), influenza A and influenza B combo kit.

The combo kit, called TaqPath, is a real-time PCR test that can detect and differentiate the ribonucleic acid (RNA) from the SARS-CoV-2, influenza A and influenza B viruses using nasopharyngeal and nasal swabs.

As the ongoing pandemic begins to have overlap with flu season, lab access to a single test that can detect multiple respiratory viruses is vital now more than ever. The TaqPath COVID-19, Flu A, Flu B combo kit will help laboratories expand their existing testing package, while allowing them to maintain a low cost of operation and workflow simplicity.

The combo kit will include the Applied Biosystems Pathogen Interpretive Software, which will automatically convert genetic analysis data into a readable report. This software will help to limit the risk of user interpretation error.

For now, the testing kit will be limited to laboratories who are certified to perform highly complex tests under the Clinical Laboratory Improvement Amendments of 1988.

"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," Mark Smedley, president of Genetic Sciences for Thermo Fisher Scientific. Thermo Fisher said. "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."