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July 1, 2022

BD receives CE-IVD mark for Covid-19, Flu and RSV combination test

The RT-PCR assay uses a single nasal or nasopharyngeal swab sample and provides results in about two hours.

Becton, Dickinson and Company (BD) has obtained CE-IVD mark for its new molecular diagnostic combination test, BD MAX Respiratory Viral Panel (RVP), for Covid-19, Flu and respiratory syncytial virus (RSV).

The new reverse transcription-polymerase chain reaction (RT-PCR) assay has been designed to detect and differentiate the mRNA of SARS-CoV-2, Influenza A, Influenza B and RSV from a single nasal or nasopharyngeal swab sample.

With the fully integrated BD MAX System’s easy-to-use and automated workflow, the test provides results in around two hours.

The company stated that the BD MAX RVP assay could help clinicians implement the correct treatment plan quickly, eliminating the need for multiple tests and doctor visits.

The combination panel also increases testing capacity.

BD Molecular Diagnostics vice-president Nikos Pavlidis said: “SARS-Cov-2, influenza and RSV are a triple threat, 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 to help manage the spread of the infections.”

The combination test runs on the company’s BD MAX System, which can analyse hundreds of samples every day.

The company noted that the new assay is an important addition to the BD MAX System, which already has a number of assays across gastrointestinal, STI, women’s health, respiratory and healthcare-associated infections.

At present, the BD MAX RVP assay is available in countries that recognise the CE mark.

BD plans to submit the assay to the US Food and Drug Administration (FDA) to seek Emergency Use Authorization in the coming weeks.

Last month, BD collaborated with CerTest Biotec to develop a molecular diagnostic test for the monkeypox virus.

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