The combination molecular diagnostic to detect SARS-CoV-2, Influenza A+B in single test has also secured CE mark


BD has secured FDA EUA and CE mark for combination molecular diagnostic test. (Credit: Becton, Dickinson and Company)

Medical technology firm Becton, Dickinson and Company (BD) has secured emergency use authorisation (EUA) from the US Food and Drug Administration (FDA) for SARS-CoV-2 and Influenza A+B diagnostic test.

The new combination molecular diagnostic test has also secured CE mark approval.

The diagnostic test, which can deliver results in two to three hours, has been developed for the detection of both SARS-CoV-2 and Influenza A+B in a single test.

The new EUA consist of updated information in the test’s instructions for use, which addresses SARS-COV-2 virus variants, including variants from the UK and South Africa.

According to the company, a computer analysis demonstrated that 99.9% of the genetic sequences of, these variants are an identical match to at least one of the two molecular targets for the test.

The BD MAX system is used to run the BD SARS-CoV-2/Flu assay, which enables to differentiate between SARS-CoV-2 and Influenza A+B and offers positive or negative results for each virus using a single specimen.

The system is a diagnostic platform that is currently used by multiple laboratories across the world. Each unit has the capacity to analyse hundreds of samples over a 24-hour period.

In October 2020, the company also secured CE mark approval for the Biotec VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit, which enables MAX System users to combine as a single test the VIASURE Flu A, Flu B & Respiratory Syncytial Virus (RSV) Real Time PCR Detection Kit and report concurrently.

BD life sciences president Dave Hickey said: “Our diagnostic solutions for COVID-19 and Flu will help inform timely diagnosis and, ultimately, may contribute to faster and clinically appropriate patient management and treatment.

“In addition, the new information provided on the test’s ability to detect the U.K. and South African variants provides helpful guidance to health care practitioners as we look to identify and contain these new strains.”

In November 2020, BD secured Health Canada authorisation for its rapid, point-of-care (POC), SARS-CoV-2 antigen test used on the BD Veritor Plus System, under an interim order.