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xTAG® GASTROINTESTINAL PATHOGEN PANEL

xTAG Gastrointestinal Pathogen Panel (GPP) pathogens

Simultaneously detect and identify multiple bacterial, viral, and parasitic pathogens…in a single test

xTAG® Gastrointestinal Pathogen Panel (GPP)

 

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

Jim Anson
Royal Liverpool & Broadgreen
University Hospital NHS Trust

Transforming GI Diagnostics

 

Get Fast, Comprehensive Results

Detect and identify >95% of the causative bacterial, viral, and parasitic agents of gastroenteritis in the same day.1,2

Simplify to a Lean Workflow

One test provides answers for 15 pathogens. Eliminate the hassle of managing multiple samples and testing methods.

Rule Out Infectious Causes

Confidently rule out infectious causes of diarrhea with the test’s 99.4% overall negative predictive value.1

Targets and Instrument Systems CE Marked in EU and SFDA Approved

 

Bacteria and Bacterial Toxins
Campylobacter
Clostridium difficile, Toxin A/B
Escherichia coli O157
Enterotoxigenic E.coli (ETEC) LT/ST
Shiga-like Toxin producing E.coli (STEC) stx1/stx2
Salmonella
Shigella
Vibrio cholerae
Yersinia enterocolitica
Viruses
Adenovirus 40/41
Norovirus GI/GII
Rotavirus A
Parasites
Cryptosporidium
Entamoeba histolytica
Giardia
Internal Control
Bacteriophage MS2
Instruments
MAGPIX® System
Luminex® 100/200™ System

xTAG Gastrointestinal Pathogen Panel Workflow

 

xTAG Gastrointestinal Pathogen Panel Workflow

 

*Time estimate of approximately five hours is for a maximum of one extraction (24 samples).

xTAG GPP Ordering Information

 

Luminex Online Order Management
Email: [email protected]
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
SFDA Approved
I032C0324
Bertin SK38 Soil Grinding Lysis Bead Tubes

(May only be sold with purchase of an xTAG GPP kit. Product not sold separately.)

100 Tubes General Purpose Reagent GR032C0442

xTAG Gastrointestinal Pathogen Panel Resources:

 

xTAG Gastrointestinal Pathogen Panel (GPP)Brochure


The State of the Art in Molecular GI TestingWhite Paper


Validation of Luminex xTAG Gastrointestinal Pathogen Panel with Stool Specimens in S.T.A.R. BufferPoster


Implementation of a Multiplex Molecular Gastrointestinal Pathogen Panel: The Memorial Healthcare System ExperiencePoster


A Novel Approach to Statewide Gastrointestinal Pathogen SurveillancePoster


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 assaysClinical Utility Article


Rapid screening method for multiple gastroenteric pathogens also detects novel enterohemorrhagic Escherichia coli O104:H4Clinical Utility Article


Short review: Molecular diagnosis of Escherichia coli O104: H4Clinical Utility Article


Utility of two novel multiplexing assays for the detection of gastrointestinal pathogens—a first experienceClinical Utility Article


Simultaneous detection of gastrointestinal pathogens with a multiplex Luminex-based molecular assay in stool samples from diarrhoeic patientsClinical 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 gastroenteritisPerformance Article


Infectious Gastroenteritis: Evaluation of Two Multiplex-PCR AssaysPerformance 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 ApproachEconomic 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


Diagnosis of Gastroenteric Infections: Comparison of Traditional Methods with the New Molecular TechnologiesPoster


Use of a Multiplex Molecular Assay for the Detection of Pathogens in Stools from Diarrheic PatientsPoster


Evaluation of a Multiplex Nucleic Acid Test for Detection of Gastrointestinal Pathogens; Utility of Luminex xTAG GPPPoster


Prospective Application of the Luminex xTAG GPP Multiplex PCR in Diagnosing Infectious GastroenteritisPoster


Clinical Performance Characteristics of the xTAG Gastrointestinal Pathogen Panel (GPP): A Multi-Center Clinical EvaluationPoster


Rapid Diagnostics from Patients Suspected to Suffer from Norovirus Infection Reveals Novel EHEC VariantPoster


Evaluation of Luminex xTAG GPP Multiplex PCR for the Diagnosis of Traveller’s DiarrhoeaPoster


Copan Flocked Rectal Swab Samples Outperform Bulk Stool for the Detection of Diarrheal Pathogens in Children When Using the xTAG Gastrointestinal Pathogen Panel (GPP) AssayPoster


A Multi-Center Clinical Evaluation of the Luminex xTAG Gastrointestinal Panel (GPP) in Patients with Clinical Signs and Symptoms of Gastrointestinal InfectionPoster


Potential Clinical Application of the xTAG GPP Multiplex Assay in Diagnosis of Gastroenteritis: A Multicentric Italian StudyPoster

  1. xTAG Gastrointestinal Pathogen Panel Kit, Package Insert (EU-IVD)
  2. Scallan E, Hoekstra RM, Angulo FJ, Tauxe RV, Widdowson MA, Roy SL, Jones JL, Griffin PM. Foodborne illness acquired in the United States–major pathogens. Emerg Infect Dis. 2011 Jan;17(1):7-15. doi: 10.3201/eid1701.091101p1.
  3. Anson J (interviewee). Gastroenteritis: A serious medical and economic burden—A new approach. Practical Patient Care UK 2012-2013.

 

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.