Luminex has received CE-IVD mark approval for its NxTAG respiratory pathogen panel, which can detect 21 clinically-relevant viral and bacterial respiratory pathogens.
The device detects pathogens such as atypical bacteria Chlamydophila pneumoniae, Mycoplasma pneumonia and Legionella pneumophila.
NxTAG has been developed for laboratories to simultaneously detect 21 respiratory pathogens in a single closed tube system, and is designed to suit the seasonal changes in demand, such as flu season.
The respiratory assay takes less time to detect pathogens and does not require any upstream reagent preparation. It enables the addition of extracted samples directly to pre-plated and lyophilized reagents.
The tubes are then sealed to undergo amplification and subsequent detection by the Luminex Magpix instrument.
NxTAG’s tube strip design allows laboratories to manage variable sample demand by processing a single sample or up to 96 samples per run, without wasting consumables or reagents.
The accompanying SYNCT software, which supports data analysis and reporting, helps the panel to incorporate easily into any laboratory.
Luminex managing director Thomas Pracht said: "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 NxTAG respiratory viral panel.
"With the CE-IVD marking of the NxTAG Respiratory Pathogen Panel, we continue to focus on delivering solutions that address our customers’ productivity needs."
In August, Luminex submitted 510(k) application to the US Food and Drug Administration (FDA) for NxTAG respiratory pathogen panel to simultaneously detect 21 respiratory pathogens in a single closed tube system.
Image: NxTAG will simultaneously detect 21 respiratory pathogens in a single closed tube system. Photo: courtesy of Luminex Corporation.