xTAG® GPP 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.
In as little as five hours, laboratories can obtain results for >90% of pathogens1,2 in a quick, streamlined workflow that eliminates the complexity of managing multiple samples and test methods. xTAG® GPP has been validated on fresh and frozen stool in addition to stool in transport media.
Detect and identify >90% of the causative bacterial, viral, and parasitic agents of gastroenteritis in the same day.1,2
One test provides answers for multiple pathogens. Eliminate the hassle of managing multiple samples and testing methods.
Confidently rule out infectious causes of diarrhea with the test’s 99.9% overall negative predictive value.1
|Bacteria and Bacterial Toxins2|
|Clostridium difficile, Toxin A/B||•||•|
|Escherichia coli O157||•||•|
|Enterotoxigenic E.coli (ETEC) LT/ST||•||•|
|Shiga-like Toxin producing E.coli (STEC) stx1/stx2||•||•|
|Luminex® 100/200™ System||•||•|
*Time estimate of approximately five hours is for a maximum of one extraction (24 samples).
|Luminex Online Order Management|
|Fax (Europe, Middle East, India, Asia):||+31 (0)73 800 1998|
|Product Name||Kit Size||Registration Status||Part Number|
|xTAG® Gastrointestinal Pathogen Panel (GPP) Kit||96 Tests||US-IVD||I032C0316|
|xTAG® Gastrointestinal Pathogen Panel (GPP) Kit Can Class III IVD||96 Tests||CA-IVD||I032C0415|
|Bertin SK38 Soil Grinding Lysis Bead Tubes
|100 Tubes||General Purpose Reagent||GR032C0442|
xTAG® Gastrointestinal Pathogen Panel (GPP) – Product Information
xTAG® Gastrointestinal Pathogen Panel (GPP) – Laboratory Brochure
xTAG® Gastrointestinal Pathogen Panel (GPP) – Clinician Brochure
The Value of Molecular GI Testing – White Paper
Microbiological diagnosis of severe diarrhea in kidney transplant recipients by use of multiplex PCR assays – Clinical Utility Article
Short review: Molecular diagnosis of Escherichia coli O104: H4 – Clinical Utility Article
Utility of two novel multiplexing assays for the detection of gastrointestinal pathogens—a first experience – Clinical Utility Article
Performance of the xTAG® Gastrointestinal Pathogen Panel, a multiplex molecular assay for simultaneous detection of bacterial, viral, and parasitic causes of infectious gastroenteritis – Performance Article
Infectious Gastroenteritis: Evaluation of Two Multiplex-PCR Assays – Performance Article
Gastroenteritis: a Serious Medical and Economic Burden – a New Approach – Economic Impact Article
Gastroenteritis and ‘Doing More With Less’ – Economic Impact Article
For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at [email protected] to obtain the appropriate product information for your country of residence.
xTAG® GPP has been validated on fresh and frozen stool in addition to stool in transport media.
The Luminex 100/200 is a class 1(I) laser product.
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.