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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 >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.

“[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 >90% 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 multiple 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 99.9% overall negative predictive value.1

Targets and Instrument Systems

 

  US-IVD CA-IVD
Bacteria and Bacterial Toxins2
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 cholerae4
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: 1.512.336.3550
Toll Free: 1.866.401.5450
Fax: 1.512.219.0544
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

(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)Laboratory Brochure


xTAG Gastrointestinal Pathogen Panel (GPP)Clinician 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


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


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


Gastroenteritis: a Serious Medical and Economic Burden – a New ApproachEconomic 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
  2. Due to low sample size, clinical sensitivity was not assessed for ETEC, Yersinia enterocolitica, and Vibrio cholerae. However, analytical accuracy for these analytes was demonstrated in the limit of detection and reactivity studies with cultural isolates or plasmids.
  3. Anson J (interviewee). Gastroenteritis: A serious medical and economic burden—A new approach. Practical Patient Care UK 2012-2013.
  4. Check your PI for respective target names.

 

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.