Thermo Fisher Scientific has secured an emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for its Applied Biosystems TaqPath Covid-19, Flu A, Flu B combo kit.
The new real-time PCR test has been developed for the identification and differentiation of RNA from the SARS-CoV2, influenza A and influenza B viruses in nasopharyngeal and nasal swabs.
According to the company, the TaqPath COVID-19, Flu A, Flu B Combo Kit enables labs to broaden their existing Covid-19 testing menu for respiratory samples while supporting low operational costs and workflow simplicity.
The kit consists of Applied Biosystems Pathogen Interpretive Software to automatically convert genetic analysis data into a readable report, thereby enabling to minimise the risk of user interpretation error.
In addition, testing with the new kit is restricted to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to conduct high-complexity tests or by similarly qualified non-US laboratories.
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.”
In December last year, the company secured CE mark approval for its TaqPath Covid-19, Flu A/B, RSV combo kit.
The combo kit is developed for the in vitro diagnosis of SARS-CoV-2, influenza A/B and respiratory syncytial virus (RSV) A/B infections.
