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Advanced Biological Laboratories Gets CE-IVD Mark for SARS-CoV-2 Variant Assay

NEW YORK — Advanced Biological Laboratories said on Monday that it has received the CE-IVD mark for its UltraGene SARS-CoV-2 Triplex Assay.

The RT-PCR-based test is in a two-well format, with one well containing primers and probes for the detection of the N and E genes of SARS-CoV-2 in upper respiratory specimens. The second well contains primers and probes designed to detect the N, S, and ORF1ab genes of the virus in order to distinguish between the three main variants of the virus in circulation, which originated in the UK, Brazil, and South Africa, respectively, Luxembourg-based ABL said.

The test is validated for use on ABL's UltraGene qPCR 48 instrument or Thermo Fisher Scientific's Applied Biosystems QuantStudio 5 system and works on platforms equipped with FAM, HEX, Cy 5, and ROX and fluorescent channels. It is available in two models for simultaneous or sequential workflows, ABL said.

In mid-2020, ABL received CE-IVD marking for its UltraGene Combo2Screen SARS-CoV-2 qPCR assay.