ELITechGroup receives CE mark

ITALY, Torino, December 9th, 2021. ELITechGroup announced today that its SARS-CoV-2 Extended ELITe MGB® Kit reliably differentiates the SARS-CoV-2 Omicron (B.1.1.529) variant from other variants of concern. The in-silico analysis was confirmed by testing patient samples positive for different SARS-CoV-2 variants including Omicron. ELITechGroup is pleased to offer the SARS-CoV-2 Extended ELITe MGB® Kit that differentiates the Alpha, Beta, Gamma, Delta, and Omicron variants in one single multiplex PCR. ELITechGroup’s proprietary MGB Pleiades® technology is at the heart of this achievement. Melting curve analysis is used as an added dimension of discrimination in addition to multiple optical channels. As a result, the discrimination of the Omicron variant requires the PCR cycler to have melting curve capability. The rapid development of the ELITe MGB Omicron typing kit demonstrates that used together, the company’s MGB Pleiades technology and melting curve analysis are ideal for mutation discrimination in multiplex PCR reactions. The SARS-CoV-2 Extended ELITe MGB® Kit can be used on ELITe InGenius®, ABI 7500 FDx, QuantStudio™ 5 and Bio-Rad CFX-96™, all of which offer melting curve capability. The SARS-CoV-2 Extended ELITe MGB® Kit uses the mutations on the S gene for discrimination. The difference in melting temperature used for the melting curve analysis is 6-7 °C, depending on the variant. The results can be interpreted and released automatically in combination with the sample-to-result ELITe InGenius® solution and/or with other common PCR cyclers. The performance of ELITechGroup’s two other CE-IVD kits used for SARS-CoV-2 detection is not affected by the Omicron variant. Both the SARS-CoV-2 ELITe MGB® Kit and the SARS-CoV-2 PLUS ELITe MGB® Kit have been shown to also reliably detect the Omicron variant. The latter kit is a multiplexed offering that also tests for Flu A, Flu B, and RSV for better clinical diagnosis of the patient. All three SARS-CoV-2 ELITechGroup PCR kits are run using a single well PCR. About ELITechGroup: ELITechGroup is a privately held group of worldwide manufacturers and distributors of in vitro diagnostic equipment and reagents. By bringing together IVD specialty companies that offer innovative products and solutions, ELITechGroup has become a major contributor in advancing clinical diagnostics to laboratories in the proximity market, those operating closer to the patient.

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