Luxembourg: SARS-CoV-2 Assays New Test Able to Detect SARS-CoV-2 Key Mutations Receives CE-IVD Registration
Diagnostic and medical software company Advanced Biological Laboratories (ABL), announced the CE-IVD registration of its Ultra Gene 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.
Luxembourg — Advanced Biological Laboratories has received CE-IVD Registration for its Ultra Gene Assay SARS-CoV-2 452R & 484K & 484Q Mutations. Especially lineages Delta and Lambda are synonymous of higher transmissibility and probably associated to a decrease of vaccines efficacy, and therefore impacting human health and health systems overall. Soon the assays will also cover tests for Lambda.
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 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.