BD, a global medtech company, and CerTest Biotec, have announced the CE mark for a molecular test that can detect and distinguish between the Alpha, Beta and Gamma COVID 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, VP 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, MD of CerTest BioTec, said: “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.
The BD MAX system, a molecular diagnostic platform, is used in hundreds of laboratories across Europe, the company says. Each unit can return results in two to three hours and is capable of analysing hundreds of samples over a 24-hour period.
