Product News: Advanced Biological Laboratories receives CE-IVD registration for its UltraGene Assay SARS-CoV-2 mutations

01 Sep 2021


Advanced Biological Laboratories (ABL) has announced 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 of higher transmissibility and probably associated to a decrease of vaccines efficacy, and therefore impacting human health and health systems overall.

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.

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