ABL offers new CE marked test for SARS-CoV-2 mutation detection


Advanced Biological Laboratories (ABL), a Luxembourg-based medical data technology company, announced today the CE-IVD registration of its UltraGene Assay SARS-CoV-2 452R & 484K & 484Q Mutations. Targeting key mutations on the virus, the test helps in this identification of the main variants of concern including lineages Delta and soon Lambda, synonymous with higher transmissibility and probably associated with a decrease of vaccines efficacy, and therefore impacting human health and health systems overall. 

The CE-IVD marking indicates that ABL’s product is according to the requirements of European Directive 98/79/EC of the European Parliament and of the council of 27 October 1998 on in vitro diagnostic medical devices (IVDD) or its successor Directive.

The assay is a real-time (rt) reverse transcriptase (RT) polymerase chain reaction (PCR) test (nucleic acid technique (NAT)) intended to screen the emergence of SARS-CoV-2 genome harboring the mutations L452R, E484K, E484Q, and soon the 452Q on the Spike (S) gene. The test is targeting the S region of SARS-CoV-2 patients’ extracted RNA. This test is intended for use only on diagnosed PCR positive to SARS-CoV-2 with a test CE-marked and authorized by competent authorities for SARS-Cov-2 screening.

“We are pleased to offer to virologists, another CE marked SARS-CoV-2 qPCR assay able to detect SARS-CoV-2 key mutations helping to quickly identify the newest variants of concern like Delta and soon Lambda which are spreading in many countries” said Dr Sayada, CEO of ABL.