Luminex’s NxTAG respiratory pathogen panel gets CE-IVD mark

20 October 2015 (Last Updated November 22nd, 2018 11:20)

Luminex has secured CE-IVD Mark approval for its NxTAG respiratory pathogen panel that is capable of detecting 21 clinically relevant viral and bacterial respiratory pathogens.

Nxstag

Luminex has secured CE-IVD Mark approval for its NxTAG respiratory pathogen panel that is capable of detecting 21 clinically relevant viral and bacterial respiratory pathogens.

The assay detects pathogens such as atypical bacteria Chlamydophila pneumoniae, Mycoplasma pneumonia and Legionella pneumophila.

NxTAG was developed for laboratories to simultaneously detect 21 respiratory pathogens in a single closed tube system, and is designed to suit 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. This workflow enables the addition of extracted samples directly to pre-plated and lyophilised 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 workflow, combined with a small instrument footprint, really answered our lab's need for fast, reliable, comprehensive respiratory testing."

University of Basel Division Infection Diagnostics and Transplantation & Clinical Virology head professor Hans Hirsch said: "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."

In addition, the accompanying SYNCT software, which supports data analysis and reporting, helps the panel to incorporate easily into any laboratory.

Separately, the company and Bio-Techne signed a new distribution and supply agreement to 2020.

The deal extends the relationship between the two companies for immunoassay development and commercialisation of Bio-Techne biological content using the Luminex testing platform.

The deal allows Bio-Techne to distribute Luminex multiplexing instrumentation, including the Luminex 200, FLEXMAP 3D and the MAGPIX platforms in major markets worldwide.

In August, Luminex submitted a 510(k) application to US Food and Drug Administration for NxTAG respiratory pathogen panel to simultaneously detect 21 respiratory pathogens in a single closed tube system.


Image: NxTAG can detect 21 respiratory pathogens in a single closed tube system. Photo: courtesy of Luminex Corporation.