The real-time PCR combo test kit is designed to simultaneously detect and differentiate SARS-CoV-2, influenza A and influenza B
Thermo Fisher Scientific has secured the US Food and Drug Administration (FDA) emergency use authorisation (EUA) for its Applied Biosystems TaqPath Covid-19, Flu A, Flu B Combo Kit.
The new combo kit is a real-time PCR test, designed to detect and differentiate RNA from the SARS-CoV2, influenza A and influenza B viruses in nasopharyngeal and nasal swabs.
It enables labs to expand their existing Covid-19 testing capabilities for respiratory samples, with reduced operational costs and simple workflow.
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.”
The combination test kit includes Applied Biosystems Pathogen Interpretive Software, which automatically converts genetic analysis data into a readable report, reducing the risk of user interpretation errors.
The regulatory authorisation limits the use of TaqPath Covid-19, Flu A, Flu B combo kit to Clinical Laboratory Improvement Amendments (CLIA) certified laboratories, or similarly qualified laboratories outside the US.
FDA has not granted the full approval to TaqPath Covid-19, Flu A, Flu B Combo Kit yet, and is only authorised for the duration of the EUA.
In March last year, the company has received the CE mark approval for its Applied Biosystems TaqPath Assay to detect nucleic acid from SARS-CoV-2, the virus that causes COVID-19.
It has recently rolled out a high throughput version of the diagnostic test, which can be used with the Automated Amplitude platform.