ABL receives CE-IVD registration for SARS-CoV-2 genotyping assay

May 27, 2021

Advanced Biological Laboratories (ABL), based in Luxembourg, announced the CE-IVD registration of its DeepChek Whole Genome SARS-CoV-2 Genotyping Assay to aid clinical applications and is intended for use on previously diagnosed COVID-19 patients, according to a company news release.

This assay — suited to small, medium, and high throughput laboratories — is intended to be used for amplifying >99% of severe acute respiratory syndrome-associated coronavirus 2 (SARS-CoV-2) genome, in upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal, and oropharyngeal swab specimens, and nasopharyngeal wash/aspirate or nasal aspirate specimens) from individuals who already have tested positive to SARS-CoV-2.

The assay, available in a kit format, provides multiplexed amplicons that can be prepared into distinct libraries or pooled with other types of samples and applications for subsequent next generation sequencing on many platforms and lab configurations.

The assay can be bundled with a downstream analysis software to perform a comprehensive list of clinically relevant analyses like SARS-CoV-2 variants identification (including UK, Indian, South African, Brazilian variants of concern databases like Pangolin and Nextclade) for cluster management. But analysis and listing of genomic variations by the analysis software, either through a cloud access or local appliances, is for Research Use Only (RUO).

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