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Bio-Rad Laboratories Gets CE Mark for SARS-CoV-2, Influenza RT-PCR Assay Kit

NEW YORK – Bio-Rad Laboratories has obtained CE-IVD marking for an assay kit to simultaneously detect SARS-CoV-2 and influenza viruses in a single reaction. The kit is now launched into European markets, the firm announced Wednesday.

The Reliance SARS-CoV-2/FluA/FluB RT-PCR Kit is a respiratory panel designed for clinical labs conducting COVID-19 testing, Bio-Rad said in a statement.

The test detects the N gene of SARS-CoV-2, the M1 gene of influenza A, and the NS2 gene of influenza B in nasopharyngeal swabs from individuals suspected of COVID-19 infection. It contains Bio-Rad's standards and negative controls and assay reagents and is validated to run on the firm's CFX96 DX Real-Time PCR system as well as real-time PCR systems from other manufacturers.

"With the upcoming flu season, a continuing COVID-19 pandemic, and many countries opening up and returning to the workplace, clinicians need a sensitive, reliable, and convenient way to detect common respiratory viruses and to differentiate cases of COVID-19 infection that do not involve flu A or flu B infection," said Steven Blakely, Bio-Rad's global director of marketing for the gene expression division of the life science group.

Bio-Rad noted that in silico analysis in March demonstrated that the assay is not affected by known variants with mutations in the spike protein-encoding gene.