On Aug. 6, 2021, BD (Becton, Dickinson) and CerTest Biotec announced the CE mark for a molecular test that can detect and distinguish between the Alpha (B.1.1.7), Beta (B.1.351) and Gamma (P.1) SARS-CoV-2 variants.

VIASURE SARS-CoV-2 Variant Real Time PCR Detection Kit for BD MAX™ can be used as a combined test with VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit for BD MAX™, or as a reflex test to run variant identification on a SARS-CoV-2 positive sample.

The test snaps into the test-specific position on the BD MAX™ ExK™ TNA extraction strip, supplied by BD.

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 new variant detection assay is part of a robust COVID-19 testing solution on the BD MAX™ System, which also includes the ability to run asymptomatic individuals using BD SARS-CoV-2 Reagents for BD MAX™ System and test saliva samples with both BD and VIASURE kits.

CerTest Biotec is a European company established in 2002 for the development and manufacturing of in vitro diagnostic medical devices. Today, CerTest is a global company structured around 5 business units offering one of the widest portfolios for human In Vitro Diagnostic. The company bases its future on a strong technical knowledge and expertise in the detection of human diseases. CerTest last generation laboratories, state-of-the-art technical equipment and skilled professionals are the keys for providing reliable solutions for the medical diagnostic professional