The FDA has cleared Luminex Corp’s NxTAG Respiratory Pathogen Panel, which detects 20 clinically relevant viral and bacterial respiratory pathogens, including the atypical bacteria Chlamydophila pneumoniae and Mycoplasma pneumonia.

According to Luminex, the panel is the only respiratory assay that enables laboratories to easily and simultaneously detect 20 respiratory pathogens in a single closed tube system in a format that scales to accommodate changes in throughput needed to respond to seasonal changes in demand, especially during flu season. The device already received a CE Mark in October.

The NxTAG Respiratory Pathogen Panel requires only minutes of hands-on time, with no upstream reagent preparation. A 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 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. Total turnaround time is only about three hours for 96 samples, excluding extraction.

“With advantages such as minimal hands-on time, fast time to results, and target masking for panel customization, the NxTAG Respiratory Pathogen Panel offers clear advantages when compared with other respiratory panels on the market,” said Homi Shamir, President and CEO of Luminex.