NEW YORK – Becton Dickinson has obtained the CE-IVD mark on a combined panel assay to detect SARS-CoV-2, influenza A and B, and respiratory syncytial virus. The assay runs on the firm's BD Max instrument and is now available in countries that recognize the CE mark, the firm said on Thursday.
Called the BD Max Respiratory Viral Panel, the RT-PCR test uses a single nasal or nasopharyngeal swab to detect and distinguish between COVID, flu, and RSV.
In a statement, BD said the assay could help clinicians implement the correct treatment more quickly and eliminate the need for multiple tests and doctor visits. A multiplex panel approach also increases testing capacity, BD said.
Nikos Pavlidis, BD's VP of molecular diagnostics, noted that symptoms of the three viruses can be nearly identical. "A combined testing panel is key to enabling clinicians to quickly and efficiently diagnose, differentiate, and treat patients to help manage the spread of the infections," he said.
The BD Max platform can analyze hundreds of samples per day, with the viral panel providing results in approximately two hours using an "easy-to-use and automated workflow," BD said.
The Franklin Lakes, New Jersey-based firm also said it plans to submit the assay to the US Food and Drug Administration for Emergency Use Authorization in the coming weeks.