Becton, Dickinson and Company (BD) has received 510(k) clearance from the US Food and Drug Administration (FDA) for its single molecular diagnostic combination test, BD Respiratory Viral Panel (RVP) for BD MAX System.
The RT-PCR assay is intended for the identification and differentiation of Respiratory Syncytial Virus (RSV), influenza A, B and SARS-CoV-2 in around two hours.
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Available in the US since February through FDA’s emergency use authorisation, the test utilises a single nasal swab or a single nasopharyngeal swab sample for determining whether the patient has RSV, Covid-19, or the flu.
The BD RVP test reduces the requirement for multiple individual tests or doctor visits and enables rapid implementation of the right treatment plan by clinicians.
With the capacity to analyse hundreds of samples over 24 hours, the BD MAX molecular diagnostic platform is already deployed at multiple medium-throughput laboratories and hospitals across the world.
BD Diagnostics general manager and vice-president Nikos Pavlidis said: “As patient symptoms and clinical presentation can be nearly identical, a combined testing panel is key to enabling clinicians to quickly and efficiently diagnose, differentiate and treat patients and help manage the spread of the infections.
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By GlobalData“The advanced robotic architecture of the BD MAX System automates manual, time-intensive processes, which has never been more important than in today’s environment of staffing shortages and laboratory scientist burnout.”
In May last year, the company secured CE mark approval for the BD Respiratory Viral Panel for BD MAX System.
