Bruker Corporation has announced that its established CE-IVD marked FluoroType® SARS-CoV-2 varID Q real-time multiplexed PCR assay reliably detects all SARS-CoV-2 variants, and in addition, is expected to also provide a clear indication of Omicron (B.1.1.529), recently declared a ‘variant of concern’ by the WHO.

FluoroType® SARS-CoV-2 varID Q is a multiplexed CE-IVD marked PCR assay for the detection and quantification of all major SARS-CoV-2 variants, based on Bruker´s proprietary LiquidArray® technology.

In addition, the assay simultaneously detects the S-gene mutations Del69-70 and N501Y, which are expected to be clear indications that the variant is Omicron (B.1.1.529). The new Omicron variant shares these mutations with the Alpha variant (B.1.1.7), but the Alpha variant is meanwhile of low epidemiological interest and only gets detected sporadically. Accordingly, by identifying Del69-70 and N501Y, the laboratory has an indication that the sample most probably is the SARS-CoV-2 Omicron variant. This can subsequently be confirmed by genomic sequencing, as is standard practice.

The FluoroType® SARS-CoV-2 varID Q also provides a viral load result according to WHO standard (IU/ml), as well as CP values and easy interpretation of mutations. The test is validated for use with nasopharyngeal and oropharyngeal swabs and contains reagents for 96 reactions. Sample extraction, amplification, and PCR results are available in under 3-4 hours.

FluoroType® SARS-CoV-2 varID Q can be run on the FluoroCycler® XT PCR instrument after sample preparation with the GenoXtract® fleXT system, which provides fully automated extraction and PCR set up. The results from the FluoroCycler® XT are analyzed by the FluoroSoftware® delivering easy-to-read results and direct indication of mutations.

Using the FluoroType® SARS-CoV-2 varID Q assay allows the user to run a screening tool for detecting SARS-CoV-2, viral load, and an early indication of the Omicron variant.

Moreover, Bruker is pleased to confirm that their full range of other FluoroType® SARS-CoV-2 assays is also expected to reliably detect the Omicron variant (B.1.1.529). These assays include:

CE-IVD assays:

• FluoroType® SARS-CoV-2 plus*
• FluoroType® SARS-CoV-2 varID Q*
• FluoroType® SARS-CoV-2/Flu/RSV*

RUO assay: FluoroType® SARS-CoV-2 evo (RUO)* **

* Not for Sale in the USA
** Not for use in clinical diagnostics procedures

All our SARS-CoV-2 assays are CE-IVD-labeled according to the European IVD Directive 98/79/EC and mainly sold into European Markets. FluoroType® SARS-CoV-2 plus is also registered and sold in some African markets including South Africa.

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