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CerTest Biotec, BD Announce Addition of Saliva to the CE Marked VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit for BD MAX™ Molecular Diagnostic System

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CerTest Biotec, along with BD (Becton, Dickinson and Company) (NYSE: BDX), a leading global medical technology company, today announced the VIASURE SARS-CoV-2 (N1 + N2) Real Time PCR Detection Kit for the BD MAX™ Molecular Diagnostic System can now be run on saliva specimens.

This allows BD MAX™ System users more flexibility with three alternatives for specimen collection: nasopharyngeal, oropharyngeal and saliva. This kit, CE marked to the IVD Directive (98/79/CE), detects all currently identified variants of SARS-CoV-2.

As the COVID-19 pandemic continues to impact Europe with additional lockdowns planned in some countries, the ability to test an ample portion of the population and identify infected people is critical to helping contain the spread and limit additional waves of the disease.

“Together with BD, we can now offer patients a non-invasive way to be tested for COVID-19 and combine that ease and comfort with the sensitivity and specificity of the RT-PCR method,” said Nelson Fernandes, managing director of CerTest BioTec.

The BD MAX™ System, a molecular diagnostic platform, is widely used in hundreds of laboratories across the EU. Each unit can return results in two to three hours and is capable of analyzing hundreds of samples over a 24-hour period.

“This new specimen type alternative for VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit for the BD MAX™ System is complementing our versatile respiratory menu and is one step further in our goal to reach more patients with the right test and at the right time,” said Nikos Pavlidis, vice president of Molecular Diagnostics at BD.

VIASURE SARS-CoV-2 (N1+N2) Real Time PCR Detection Kit for the BD MAX™ Molecular Diagnostic System is sold through BD’s distribution network. The test snaps into the test-specific position on the BD MAX™ ExK™ TNA Extraction Strip, supplied by BD.


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