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 (US-IVD):
The xTAG Gastrointestinal Pathogen Panel (GPP) is a multiplexed nucleic acid test intended for the simultaneous qualitative detection and identification of multiple viral, bacterial and parasitic nucleic acids in human stool specimens or human stool in Cary-Blair media from individuals with signs and symptoms of infectious colitis or gastroenteritis.
The detection and identification of specific gastrointestinal microbial nucleic acid from individuals exhibiting signs and symptoms of gastrointestinal infection aids in the diagnosis of gastrointestinal infection when used in conjunction with clinical evaluation, laboratory findings, and epidemiological information. A gastrointestinal microorganism multiplex nucleic acid-based assay also aids in the detection and identification of acute gastroenteritis in the context of outbreaks.
xTAG GPP positive results are presumptive and must be confirmed by FDA-cleared tests or other acceptable reference methods.
The results of this test should not be used as the sole basis for diagnosis, treatment, or other patient management decisions. Confirmed positive results do not rule out co-infection with other organisms that are not detected by this test, and may not be the sole or definitive cause of patient illness. Negative xTAG GPP results in the setting of clinical illness compatible with gastroenteritis may be due to infection by pathogens that are not detected by this test or non-infectious causes such as ulcerative colitis, irritable bowel syndrome, or Crohn’s disease.
xTAG GPP is not intended to monitor or guide treatment for C. difficile infections.
The xTAG GPP test is indicated for use with the Luminex 100/200 and MAGPIX instruments with xPONENT® software.
Intended Use (CA-IVD):
The xTAG® Gastrointestinal Pathogen Panel (GPP) is a qualitative multiplex test intended for the simultaneous detection and identification of nucleic acids from multiple gastroenteritis causing 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 and is not intended to monitor or guide treatment for C.difficile infections.
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.