CE mark for Eurobio Scientific’s new proprietary test for the detection of Omicron BA.xBA.2 and Delta variants of SARS-CoV-2
- A routine COVID screening test that simultaneously detects and identifies the presence of Omicron BA.xOmicron BA.2 and screens for other Delta variants
- First CE market French test for screening for Omicron and Delta variants requiring only one reaction and delivering a result in 45 minutes
Paris, April 14, 2022 – 8:00 am
Eurobio Scientific (FR0013240934, ALERS, PEA-PME eligible), a leading French group in specialty in vitro medical diagnostics, announces the CE mark of its new proprietary test, EBX 048, Eurobioplex SARS-CoV-2 Fast-SVT (Screening and VOC1 Typing)developed specifically for routine COVID-19 screening and identification of current variants.
The proprietary EBX SARS-CoV-2 Fast-SVT is a real-time polymerase chain reaction (RT-PCR2) assay that, in a single test, identifies the presence of the SARS-CoV-2 virus and detects the K417N (Omicron variant BA.x sublineage screening), V213G (Omicron variant BA.2 sublineage screening) and L452R (Delta variant screening) mutations in a qualitative manner. The presence of the V213G mutation thus allows the BA.2 sublineage to be differentiated from other sublineages of the Omicron variant.
This new test, designed and developed by Eurobio Scientific’s R&D department, is produced in-house, in its premises in Les Ulis – France and follows the ISO 13485 regulatory process. It is available in several versions allowing 50, 100 or 200 determinations to be performed simultaneously.
While, in France and for the past week, the number of daily hospitalizations and the number of admittances into emergency units rose by approximately 10%3while the number of positive COVID tests increased by 77%3, EBX SARS-CoV-2 Fast-SVT is immediately available for hospital and private laboratories, both in France and internationally. It is the first CE marked test able to specifically identify the BA.2 sub-variant which is currently involved in 92% of COVID infections in France4and to track the incidence of the L452R mutation, which, if rising, could signal a return to more severe forms of COVID-19.
EBX SARS-CoV-2 Fast-SVT is therefore a means of controlling the epidemic, while a resurgence of hospitalizations is observed in France, in connection with a sustained circulation of the Omicron BA.2 variant, and in an overall context of risk of loss of vaccine immunity or immune escape.
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1 VOC: Variant of Concern
2 The “Polymerase Chain Reaction” (PCR) is a method based on the selective multiplication of target DNA sequences, which makes it possible to detect specific DNA sequences present in a product.
4 Public Health France – COVID-19: epidemiological point of 7 April 2022, n ° 110