The CE mark enables the use of the VIASURE SARS-CoV-2 (N1 + N2) real-time PCR detection kit on the BD MAX system
CerTest Biotec and Becton, Dickinson and Company (BD) have secured CE mark approval for combined Covid-19, influenza and respiratory syncytial virus (RSV) test on the BD MAX system.
The CE mark approval has been granted to use the VIASURE SARS-CoV-2 (N1 + N2) real-time PCR detection kit on the system.
The kit enables BD MAX system users to run a single module, which tests concurrently for Covid-19 and influenza (flu) and RSV.
CerTest Biotec managing director Nelson Fernandes said: “The new CerTest kit will provide rapid Covid-19 diagnostic capabilities that can be run individually or combined with detection of Flu A, Flu B and RSV A and B.
“As we enter flu season, the ability to test for both COVID-19 and Flu at the same time will speed diagnosis and, ultimately, treatment.”
BD MAX system is used in multiple European laboratories
BD MAX system is a molecular diagnostic platform that is used in multiple laboratories across Europe.
Each unit can deliver results in two to three hours, as well as holds the capacity to analyse hundreds of samples over a 24-hour period.
The CerTest tests are said to snap into the test-specific position on the BD MAX ExK TNA extraction strip provided by BD.
BD’s network will sell VIASURE SARS-CoV-2 (N1+N2) real-time PCR detection kit for the BD MAX system and the VIASURE Flu A, Flu B & RSV real-time PCR detection kit for the BD MAX system. The products are not available for sale in the US.
BD molecular diagnostics and women’s health vice president Nikos Pavlidis said: “Together with CerTest, we can offer our customers in Europe a complete solution for Covid-19 diagnostics during the winter season.
“By leveraging our significant installed base and the versatility of the BD MAX System, this test will greatly enhance capacity for SARS-CoV-2 and Influenza testing, enabling clinicians to rapidly diagnose patients and help reduce the spread of Covid-19.”
Recently, BD announced the CE mark and marketing of its assay to assess immune function of Covid-19 patients, in the European Union (EU).