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Luminex Corporation Receives CE-IVD Mark for NxTAG®

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Luminex Corporation has announced that it has received CE-IVD marking for its NxTAG® Respiratory Pathogen Panel.  The Panel detects 21 clinically-relevant viral and bacterial respiratory pathogens, including the atypical bacteria Chlamydophila pneumoniae, Mycoplasma pneumoniae, and Legionella pneumophila. The NxTAG Respiratory Pathogen Panel is the only respiratory assay that easily enables laboratories to simultaneously detect 21 respiratory pathogens in a single closed tube system that scales to accommodate changes in throughput needed to respond to seasonal changes in demand, such as during flu season.

The NxTAG Respiratory Pathogen Panel requires only minutes of hands-on time with no upstream reagent preparation. The simplified workflow allows extracted samples to be added directly to pre-plated, lyophilized reagents. The tubes are then sealed and ready for closed tube amplification and subsequent detection using the Luminex MAGPIX® instrument. The innovative tube strip design offers laboratories the flexibility to manage variable sample demand by processing a single sample or up to as many as 96 samples per run, without wasting consumables or reagents, or the need to have full batches. Total turnaround time is just over three hours for 96 samples (excluding extraction).


In addition, the accompanying SYNCT™ Software provides a comprehensive approach to data analysis and reporting, and enables the NxTAG Respiratory Pathogen Panel to integrate easily into any laboratory. Any of a number of targets can be selected by laboratories to customize their testing panel.

"With the NxTAG Respiratory Pathogen Panel, we found that shorter hands-on and turnaround times, together with a simpler closed tube process, made for an impressively streamlined workflow.  The workflow, combined with a small instrument footprint, really answered our lab's need for fast, reliable, comprehensive respiratory testing," said Professor Hans H. Hirsch, M.D., Head of the Division Infection Diagnostics and Transplantation & Clinical Virology at the University of Basel, Switzerland.

"As a leader in multiplexed solutions, we are excited to launch the next generation NxTAG Respiratory Pathogen Panel which delivers expanded coverage and a simple closed tube workflow, combined with the throughput and quality of results established by the xTAG Respiratory Viral Panel," said Thomas Pracht, Managing Director, EMEIA, Luminex Corporation.  "With the CE-IVD marking of the NxTAG Respiratory Pathogen Panel, we continue to focus on delivering solutions that address our customers' productivity needs."