Industry News: BD and CerTest Biotec announce CE mark for molecular test to detect, identify certain SARS-CoV-2 variants

06 Aug 2021


BD (Becton, Dickinson and Company), a leading global medical technology company, and CerTest Biotec, has 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 SARS-CoV-2 virus has shown rapid mutation, and the ability to monitor variants that have the potential for increased severity or transmissibility is a critical tool in the fight against this virus,” said Fernand Goldblat, vice president and general manager of Integrated Diagnostic Solutions for BD in Europe, Middle East and Africa. “Along with sequencing, diagnostic screening assays are an important part of the strategy to identify, differentiate and contain variants of concern.”

Fernandes, managing director of CerTest BioTec, added “The VIASURE SARS-CoV-2 (N1+N2) Real Time Detection Kit for BD MAX™ and VIASURE SARS-CoV-2 Variant Real Time PCR Detection Kit for BD MAX™ are available with three alternatives for specimen collection: nasopharyngeal, oropharyngeal and saliva. Since the same single specimen can be used to run both assays to detect SARS-CoV-2 and test for its variants, the system provides a comprehensive solution for SARS-CoV-2 testing.”

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.

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