xTAG® GPP1 is a multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of multiple viral, parasitic, and bacterial nucleic acids in human stool specimens from individuals with signs and symptoms of infectious colitis or gastroenteritis.
“[xTAG GPP] also brings a much needed degree of scalability. If we’re doing 80 stools a day, for example, then being able to extract multiple pathogens at once for the PCR run, rather than just one or two at a time, allows us to be a lot more efficient, and that means we can have a much quicker results turnaround.” 2
Royal Liverpool & Broadgreen
University Hospital NHS Trust
Intended Use (EU-IVD/SFDA Approved):
The xTAG® Gastrointestinal Pathogen Panel (GPP) is a qualitative multiplex test intended for the simultaneous detection and identification of nucleic acids from multiple gastroenteritiscausing viruses, parasites and bacteria (including toxin gene detection) in human stool samples that are fresh, frozen or in a holding medium, from individuals with signs and symptoms of infectious colitis or gastroenteritis.
The xTAG GPP assay is indicated as an aid in the detection and identification of bacterial, parasitic and viral agents causing gastrointestinal infections in symptomatic (both acute and chronic gastroenteritis) adult and pediatric patients, who are either hospitalized, admitted to emergency departments or who are outpatients with suspected gastroenteritis. The xTAG GPP assay is also indicated for use as an epidemiological surveillance tool in Public Health Laboratories.
The xTAG GPP is indicated for use with either the Luminex 100/200 or MAGPIX instruments.
The xTAG GPP assay is not indicated as a stand-alone diagnostic tool, and should be used in conjunction with other clinical and laboratory findings.