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CE-IVD mark for respiratory pathogen panel, 12/15

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Luminex 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 panel enables laboratories to simultaneously detect 21 respiratory pathogens in a single closed tube system that scales to accommodate changes in throughput due to shifts in demand (such as during flu season).

The NxTAG Respiratory Pathogen Panel requires only minutes of hands-on time with no upstream reagent preparation; extracted samples can 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 tube strip design offers laboratories the flexibility to manage variable sample demand by processing a single sample or up to 96 samples per run. Total turnaround time is just over three hours for 96 samples, excluding extraction.

The accompanying Synct Software provides a comprehensive approach to data analysis and reporting and enables the NxTAG Respiratory Pathogen Panel to integrate into any laboratory. Any of a number of targets can be selected to customize the testing panel.

Luminex, 512-381-4397

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