Eurobio Scientific has obtained the CE mark for its test EBX 047, Eurobioplex SARS-CoV-2 Fast Screening and Variants Detection (SVD).
The new real-time multiplex polymerase chain reaction (PCR) kit has been specifically developed to detect Covid-19, as well as the current Omicron and Delta variants.
Go deeper with GlobalData
The CE marking for the test comes after the launch of its research use only (RUO) version on 30 November.
Eurobio’s research and development (R&D) team designed and developed the new test in-house at its facility in Les Ulis, France.
The EBX SARS-CoV-2 Fast-SVD test requires only one reaction and provides results in 45 minutes. It has been expanded compared to its first version.
The test targets the L452R mutation present on the Delta variant, as well as the K417N mutation present on the Omicron and Beta variants.
It also targets the E484K mutation present on the Beta and Gamma variants.
Eurobio Scientific said in a statement: “The presence of the K417N mutation without the E484K mutation also makes it possible to differentiate the Omicron variant from the Beta variant and to screen the Omicron variant.”
The company noted that the test is immediately available for hospitals and private laboratories in France and across the world.
The EBX SARS-CoV-2 Fast-SVD test is available in several versions, allowing 48, 96 or 192 tests to be conducted.
Recently, Qiagen also obtained the CE mark for its QuantiFeron SARS-CoV-2 assay, which has the ability to assess the T-cell response to Covid-19.
The SARS-CoV-2 assay is designed to identify interferon-γ (IFN-γ) produced by CD4+ and CD8+ T cells in response to a SARS-CoV-2 peptide cocktail in the blood.
