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27th April 2021  Product update: rapidmicrobiology staff writer

Ultragene SARS-CoV-2 Variant Triplex Assay Receives CE-IVD


Advanced Biological Laboratories (ABL) has announced 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 SARS-CoV-2 and genomic variations on the Spike (S) gene and 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 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”)
  • SARS-CoV-2 lineage P.1 (i.e., Brazil VOC 202101/02; “BR”)

Available in a two-well 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). 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 work on platforms equipped with FAM, HEX, Cy 5, and ROX and fluorescent 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 an rRT-PCR run for the SARS-CoV-2 Screening (Well #1), and then performing, sequentially, a second RNA isolation from an upper respiratory specimen from positive SARS-CoV-2 patients followed by an rRT-PCR run for the SARS-CoV-2 Variant detection and typing (Well #2).

To learn more about UltraGene® Assay SARS-CoV-2 Triplex, Screening, Multi-Variants, and Typing V1, please click here.


    

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Date Published: 27th April 2021

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Note: This content has been edited by a rapidvirology.com staff writer for style and content.


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