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 15 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.
“[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.” 3
Royal Liverpool & Broadgreen
University Hospital NHS Trust
Detect and identify >95% of the causative bacterial, viral, and parasitic agents of gastroenteritis in the same day.1,2
One test provides answers for 15 pathogens. Eliminate the hassle of managing multiple samples and testing methods.
Confidently rule out infectious causes of diarrhea with the test’s 99.4% overall negative predictive value.1
|Bacteria and Bacterial Toxins|
|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|
|Phone:||+31 (0)73 800 1900|
|Fax:||+31 (0)73 800 1998|
|Product Name||Kit Size||Registration Status||Part Number|
|xTAG® Gastrointestinal Pathogen Panel (GPP) Kit (EU/ROW IVD)||96 Tests||CE Marked in EU
|Bertin SK38 Soil Grinding Lysis Bead Tubes
|100 Tubes||General Purpose Reagent||GR032C0442|
xTAG® Gastrointestinal Pathogen Panel (GPP) (CE-IVD) – Product Information
The State of the Art in Molecular GI Testing – White Paper
Multiplex molecular testing for management of infectious gastroenteritis in a hospital setting: a comparative diagnostic and clinical utility study – Halligan E, Edgeworth J, Bisnauthsing K, Bible J, Cliff P, Aarons E, Klein J, Patel A, Goldenberg S. Clin Microbiol Infect. 2013 Nov 26. doi: 10.1111/1469-0691.12476. – Clinical Utility/Economic Impact Article
Gastrointestinal pathogens detected by multiplex nucleic acid amplification testing in stools of pediatric patients and patients returning from the tropics – Beckmann C, Heininger U, Marti H, Hirsch HH. Infection. 2014 Jul 12. [Epub ahead of print] – Clinical Utility Article
Aetiology of traveller’s diarrhoea: evaluation of a multiplex PCR tool to detect different enteropathogens – Zboromyrska Y, Hurtado JC, Salvador P, Alvarez-Martínez MJ, Valls ME, Mas J, Marcos MA, Gascón J, Vila J. Clin Microbiol Infect. 2014 Mar 13. doi: 10.1111/1469-0691.12621. – Clinical Utility Article
Added value of multiplex Luminex Gastrointestinal Pathogen Panel (xTAG GPP) testing in the diagnosis of infectious gastroenteritis – Wessels E, Rusman LG, van Bussel MJ, Claas EC. Clin Microbiol Infect. 2014 Mar;20(3):O182-7. doi: 10.1111/1469-0691.12364. Epub 2013 Oct 17. – Clinical Utility Article
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
The increasing application of multiplex nucleic acid detection tests to the diagnosis of syndromic infections – Gray J, Coupland LJ. Epidemiol Infect. 2014 Jan;142(1):1-11. doi: 10.1017/S0950268813002367. Epub 2013 Oct 7. Review. – Performance Article
Evaluation of the Luminex xTAG Gastrointestinal Pathogen Panel and the Savyon Diagnostics Gastrointestinal Infection Panel for the detection of enteric pathogens in clinical samples – Perry MD, Corden SA, Howe RA. J Med Microbiol. 2014 Aug 7. pii: jmm.0.074773-0. doi: 10.1099/jmm.0.074773-0. [Epub ahead of print] PMID:25102908 [PubMed – as supplied by publisher] – Performance 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
Multiplex molecular testing for management of infectious gastroenteritis in a hospital setting: a comparative diagnostic and clinical utility study – Halligan E, Edgeworth J, Bisnauthsing K, Bible J, Cliff P, Aarons E, Klein J, Patel A, Goldenberg S. Clin Microbiol Infect. 2013 Nov 26. doi: 10.1111/1469-0691.12476. – Economic Impact Article
Gastroenteritis: a Serious Medical and Economic Burden – a New Approach – Economic Impact Article
Utility of two novel multiplexing assays for the detection of gastrointestinal pathogens – a first experience – Kahlau P, Malecki M, Schildgen V, Schulz C, Winterfeld I, Messler S, Mattner F, Schildgen O. Springerplus. 2013 Dec;2(1):106. – 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 (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.