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        GVS Flame CoViD-19 VARIANTS qPCR Master Kit and OMICRON Variant

        Young team during coronavirus lab tests. Wearing protective masks and caps.

        The new Variant B.1.1.529 known as "OMICRON", which has been designated a "Variant of Concern" by the World Health Organization (WHO), has more than 30 mutations in the Spike protein alone.

        WHO reported that preliminary evidence suggests an increased risk of transmission compared to other Variants of Concern.

        This designation and information are leading to renewed travel restrictions and research to examine the variant's impact on the efficacy of existing vaccines and tests.

        The OMICRON Variant has been found to include the N501Y gene mutation, first identified in the Alpha Variant.

        The presence of this mutation identified by the GVS Flame CoViD-19 VARIANTS qPCR Master Kit - CE-IVD (Item code FLM0002) could immediately indicate a suspected possible OMICRON Variant infection.

        Confirmation must then be performed by sequencing the sample.

        The WHO and the European Centers for Disease Control have also reported the risk of the lower sensitivity of qPCR kits due to the absence of gene recognition with a consequent increase in false negatives in the presence of the OMICRON Variant.

        Here is a list of tests already reported by the FDA SARS-CoV-2 Viral Mutations: Impact on COVID-19 Tests | FDA.

        What consequences could the laboratory activity have to face?

        What measures could help for immediate detection and tracking?

        The GVS Flame CoViD-19 VARIANTS qPCR Master Kit - CE-IVD kit (Item code FLM0002), based on the detection of 4 parameters, one of which is the mutation of the N501Y gene, allows:

        • immediate identification of suspected positive sample for OMICRON Variant;
        • maintain a very high sensitivity and specificity even in the presence of the new Variant;
        • qPCR time of 45 minutes;ù
        • reduction or optimization of the samples to be sequenced in an epidemic phase in which the cases of positivity are increasing.

        Additionally, further confirmation in the laboratory is possible by the use of the Flame DELTA VARIANTS REFLEX REAGENT KIT (Item code FLM0003) which allows with a second reflex qPCR run to verify the presence of the mutation of the N501Y gene, common to both the OMICRON and Delta Variants.

        For further information or to set up a demo, contact us at [email protected]

        Flame-CoViD--19-VARIANTS-IFU.pdf Flame-CoViD--19-VARIANTS-qPCR-Master-Kit.pdf

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