BD and CerTest Biotec Announce CE Mark for Molecular Test to Detect...

BD and CerTest Biotec Announce CE Mark for Molecular Test to Detect and Identify Certain SARS-CoV-2 Variants

Healthcare Tech Outlook | Friday, August 13, 2021

BD and CerTest Biotec announce the CE mark for a molecular test that can identify and distinguish between the Alpha (B.1.1.7), Beta (B.1.351), and Gamma (P.1) SARS-CoV-2 variants.

FREMONT, CA: BD (Becton, Dickinson, and Company), a prominent worldwide medical technology firm, and CerTest Biotec, have announced the CE mark for a molecular test that can identify and distinguish between the Alpha (B.1.1.7), Beta (B.1.351), and Gamma (P.1) SARS-CoV-2.

VIASURE SARS-CoV-2 (N1+N2) Real-Time PCR Detection Kit for BD MAX can be companied for evaluation with the VIASURE SARS-CoV-2 Variant Real-Time PCR Detection Kit for BD MAX. It can even be used as a reflex test to run various detection 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.”

Nelson 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 fits into place on the BD MAX ExK TNA extraction strip in the test-specific position.

Several laboratories around Europe employ the BD MAX System, a molecular diagnostic platform. Every unit can analyze numerous samples in 24 hours and returns results in two to three hours. The novel variant identification assay is part of a powerful COVID-19 testing solution on the BD MAX System, which also provides the capacity to test saliva samples with both BD and VIASURE kits and run asymptomatic patients utilizing BD SARS-CoV-2 Reagents for the BD MAX System.

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