FDA grants EUA for Thermo Fisher Scientific’s Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit. Credit: Thermo Fisher Scientific Inc.

Thermo Fisher Scientific has received emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its multiplex real-time PCR test, Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit.

The kit is used for identifying and distinguishing RNA from the SARS-CoV2, and influenza A and B viruses in nasopharyngeal and nasal swabs.

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Thermo Fisher Scientific Genetic Sciences president Mark Smedley said: “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.

“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.”

Apart from aiding laboratories in increasing their present Covid-19 testing menu for respiratory samples, the kit will help maintain low operational costs and simple workflow.

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Furthermore, the TaqPath COVID-19, Flu A, Flu B Combo Kit includes Applied Biosystems Pathogen Interpretive Software for automatically converting genetic analysis data into a readable report. This will lower the chances of user interpretation error.

Thermo Fisher noted that testing with the kit is limited to Clinical Laboratory Improvement Amendments of 1988 (CLIA) certified laboratories for carrying out high-complexity tests or by non-US labs with similar qualifications.

Last December, the company introduced a new direct-from-saliva PCR test for Covid-19 to support extensive, high-frequency surveillance testing.

The Applied Biosystems TaqCheck SARS-CoV-2 Fast PCR Assay uses raw saliva samples to streamline lab workflows with the help of tools available worldwide to provide reliable data rapidly.