BD and CerTest Biotec get CE mark for molecular test to detect, identify certain SARS-CoV-2 variants

August 6, 2021  –  BD (Becton, Dickinson and Company) (Franklin Lakes, NJ) 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 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.

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

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.

VIASURE SARS-CoV-2 Variant Real Time PCR Detection Kit for the BD MAX System is sold through BD’s distribution network. VIASURE Kits are not available for sale in the United States.

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