CE-IVD Marking for Respiratory Bacterial ELITe MGB® Panel
ELITechGroup Molecular Diagnostics have launched a high-performance multiplex assay, Respiratory Bacterial ELITe MGB® Panel, for the diagnosis of bacterial respiratory infections, validated with ELITe InGenius®, ELITechGroup’s fully automated sample to result system.
In combination with ELITe InGenius, the Respiratory Bacterial ELITe MGB® Panel is the first panel specifically designed to detect main relevant respiratory bacteria, CE-IVD validated with a sample-to-result system. Respiratory Bacterial ELITe MGB® Panel detects and differentiates in one single reaction M. pneumoniae, C. pneumoniae, and L. pneumophila. The clinical study has demonstrated excellent performance: 100% diagnostic sensitivity and 100% diagnostic specificity were obtained with all targets.
The validation with ELITe InGenius offers many advantages to laboratories in comparison to other solutions available on the market: fully automated workflow from extraction to result interpretation, hands-on time reduced to few minutes, and accurate results.
“We are proud to extend the ELITe InGenius respiratory menu which now enables laboratories to diagnose the main relevant virus and bacteria involved in respiratory infections. Aligned with our menu expansion strategy, this new assay strengthens the ELITe InGenius offer providing our customers with the largest CE-IVD menu for infectious disease testing available on an integrated sample-to-result solution” commented Christoph Gauer, CEO of ELITechGroup.
The CE-IVD ELITe InGenius respiratory menu will be further broadened in the coming months with a new Real-Time PCR assay for the detection of Mycobacterium tuberculosis and associated multidrug resistant forms to rifampicin, and isoniazid.
Tags: Listeria monocytogenes, Mycobacterium tuberculosis, Respiratory panel, Chlamydia pneumoniae
Date Published: February 20, 2018
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