On Oct. 21, 2020, CerTest Biotec, along with BD (Becton, Dickinson), announced that the VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit adapted for the BD MAXﾙ System has been CE marked to the IVD Directive (98/79/EC).

This 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 United States.