FDA Grants EUA for COVID-19 combo test kit

Thermo Fisher Scientific announced that the U.S. Food and Drug Administration (FDA) has granted emergency use authorization (EUA) for the company’s Applied Biosystems TaqPath COVID-19, Flu A, Flu B Combo Kit, according to a news release from Thermo Fisher.

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 TaqPath COVID-19, Flu A, Flu B Combo Kit includes Applied Biosystems Pathogen Interpretive Software to automatically convert genetic analysis data into a readable report, helping reduce risk of user interpretation error.

Testing with the TaqPath COVID-19, Flu A, Flu B Combo Kit is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA) to perform high-complexity tests.

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