BD, Certest Biotec Get IVDR Certification for Infectious Disease Assays

Original from: genomeweb

Becton Dickinson said Monday that its partner Certest Biotec has received In Vitro Diagnostic Medical Device Regulation certifications in Europe for two infectious disease assays.

The certifications were granted to the Viasure Respiratory Virus Extended Mix Real Time PCR Detection Kit — which detects respiratory viruses including SARS-CoV-2, respiratory syncytial virus, and influenza in nasopharyngeal swabs — and the Viasure HSV-1, HSV-2, and Treponema pallidumAssay — which detects herpes simplex viruses and the bacteria that causes syphilis in anogenital and oral skin lesion swabs.

The assays were developed by Zaragoza, Spain-based Certest and are designed to run on Becton Dickinson's BD Max automated molecular diagnostic system.

Becton Dickinson and Certest began working together in 2017 and have released tests for a variety of infections including monkeypox and COVID-19.

Source: BD, Certest Biotec Get IVDR Certification for Infectious Disease Assays