CE mark for respiratory pathogen detection

LUMINEX reports that it has received CE-IVD marking for its NxTAG respiratory pathogen panel.

Luminex says the NxTAG panel detects over 20 different respiratory bacteria and viruses

The panel detects 21 clinically-relevant viral and bacterial respiratory pathogens, including the atypical bacteria Chlamydophila pneumoniae, Mycoplasma pneumoniae, and Legionella pneumophila.

The company says NxTAG enables laboratories to simultaneously detect 21 respiratory pathogens in a single closed tube system.

Further, the system scales to respond to seasonal changes in demand, such as during flu season.

The panel requires only minutes of hands-on time with no upstream reagent preparation, it adds.

The simplified workflow allows extracted samples to be added directly to pre-plated, lyophilized reagents.

Tubes are then sealed and ready for closed tube amplification and subsequent detection using Luminex’s 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 just over three hours for 96 samples (excluding extraction).

“With NxTAG, 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, answered our lab’s need for fast, reliable, comprehensive respiratory testing,” said Professor Hans Hirsch, head of the division infection diagnostics and transplantation and clinical virology at the University of Basel, Switzerland.

Many commonly encountered respiratory pathogens (viral and bacterial) have similar clinical presentation, making diagnosis based on symptoms alone very difficult. Influenza viruses commonly cause respiratory illness, but many other pathogens may cause significant impact on patient health as well. Respiratory syncytial virus (RSV), as one example, is the most common cause of severe respiratory illness in young children, as well as a leading cause of death from respiratory illness in those aged 65 years and older.


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