CerTest Biotec and BD Secure CE Mark for Combination COVID-19, Influenza, RSV Test on BD MAX System

CerTest Biotec (Zaragoza, Spain), along with Becton, Dickinson and Company (BD Franklin Lakes, NJ, USA), have announced that the VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit adapted for the BD MAX System has been CE marked.

The kit allows BD MAX System users to run a single module that tests concurrently for COVID-19 and Influenza (Flu) and Respiratory Syncytial Virus (RSV). The BD MAX System, a molecular diagnostic platform, is widely used in hundreds of laboratories across Europe. Each unit can return results in two to three hours and is capable of analyzing hundreds of samples over a 24-hour period. The CerTest tests snaps into the test-specific position on the BD MAX ExK TNA extraction strip, supplied by BD. VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit for the BD MAX System and the VIASURE Flu A, Flu B & RSV Real Time PCR Detection Kit for the BD MAX System are sold through BD's network and are not available for sale in the US.


"The new CerTest kit will provide rapid COVID-19 diagnostic capabilities that can be run individually or combined with detection of Flu A, Flu B and RSV A and B," said Nelson Fernandes, managing director of CerTest Biotec. "As we enter flu season, the ability to test for both COVID-19 and Flu at the same time will speed diagnosis and, ultimately, treatment."

"Together with CerTest, we can offer our customers in Europe a complete solution for COVID-19 diagnostics during the winter season," said Nikos Pavlidis, vice president of Molecular Diagnostics and Women's Health for BD. "By leveraging our significant installed base and the versatility of the BD MAX System, this test will greatly enhance capacity for SARS-CoV-2 and Influenza testing, enabling clinicians to rapidly diagnose patients and help reduce the spread of COVID-19."

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Becton, Dickinson and Company
CerTest Biotec