Advanced Biological Laboratories Receives CE-IVD Registration for its UltraGene SARS-CoV-2 Triplex Assay

Advanced Biological Laboratories Receives CE-IVD Registration for its UltraGene SARS-CoV-2 Triplex Assay

Advanced Biological Laboratories (ABL) announced today the CE-IVD registration of its UltraGene® SARS-CoV-2 Triplex Assay, now available for in-vitro diagnostics use.

This innovative test is a real-time RT-PCR test intended for the qualitative detection of RNA from the SARS-CoV-2and genomic variations on the Spike (S) gene and on the ORF1ab gene in upper respiratory specimens from individuals suspected of COVID-19 by their healthcare provider.

Assay results are for the identification of SARS-CoV-2 RNA, the detection of a SARS-CoV-2 variant from a wild-type strain and for the distinction of main circulating SARS-CoV-2 variants (SARS-CoV-2 lineage B.1.1.7 (i.e. United Kingdom VOC 202012/01, VOC 202102/02; “UK”), SARS-CoV-2 lineage B.1.351 (i.e. South Africa VOC 202012/02; “SA”) and SARS-CoV-2 lineage P.1 (i.e. Brazil VOC 202101/02; “BR”).

Available in a two-wells format per sample, the test includes in the first well, primer and probe sets designed to detect RNA from the SARS-CoV-2 nucleocapsid (N) gene and envelope (E) gene in upper respiratory specimens (such as nasal, mid-turbinate, nasopharyngeal, oropharyngeal swab specimens and nasopharyngeal wash/aspirate or nasal aspirate and bronchoalveolar lavage (BAL) fluid specimens) from individuals suspected of COVID-19 by their healthcare provider. It also includes an extraction, reverse transcription, and PCR amplification positive control

The second well includes primer and probe sets designed to detect RNA from the SARS-CoV-2 nucleocapsid (N), Spike (S) and ORF1ab allowing precise identification of lineages B.1.1.7, B.1.351 and P.1.

Validated on the UltraGene qPCR 48 or Applied Biosystems QuantStudio 5 instruments, the tests works on plaforms equipped with FAM, HEX, Cy 5, and ROX and flurorescent channels and is available in two models for two distinct workflows. The «Simultaneous» workflow is for sites willing to perform a single RNA isolation followed by a direct rRT-PCR of the two wells simultaneously within the same run. The «Sequential» workflow is for sites willing to perform a first RNA isolation followed by a rRT-PCR run for the SARS-CoV-2 Screening (Well #1), and then performing, sequentially, a second RNA isolation from upper respiratory specimen from positive SARS-CoV-2 patients followed by a rRT-PCR run for the SARS-CoV-2 Variant detection and typing (Well #2).

“Completing the CE-IVD marking of our UltraGene® SARS-CoV-2 Triplex assay is a real achievement which shall bring lots of efficiency to healthcare professionals fighting COVID-19 and to labs constantly requiring new innovative diagnostics products” said Dr. Sofiane Mohamed, Technical & Scientific Director of ABL.

“For more than one year and since the beginning of the pandemic, ABL is committed to develop and provide to microbiology labs, robust solutions including genotyping & RT-PCR tests which aid optimizing overall patients management.” explained Dr. Chalom Sayada, CEO of the ABL Group.

To learn more about UltraGene® Assay SARS-CoV-2 Triplex, Screening, Multi-Variants and Typing V1, please visit https://www.ablsa.com/laboratory-applications/ultragene-triplex/