Now available in the US.

xTAG® Gastrointestinal Pathogen Panel (xTAG GPP)

Now you can test for key bacteria, viruses, and parasites - same day with a single test.

xTAG GPP is a qualitative molecular multiplex test intended for the simultaneous detection and identification of multiple gastrointestinal pathogens including bacteria, viruses, and parasites. The assay uses the proprietary Luminex xTAG® Technology and the xMAP® Technology platform to detect multiple targets in a single sample. xTAG GPP can detect agents that can cause Hospital Acquired Infections (HAI) such as C. difficile or norovirus, foodborne illness agents like E. coli or Salmonella, and common causes of diarrhea in infants and in children 5 years old and younger, such as rotavirus A, Campylobacter, and Shigella.

Gastroenteritis Is A Serious Global Problem 

Globally, there are an estimated two billion cases of diarrheal disease every year which kill approximately 1.8 million people annually. Diarrheal disease is the second leading cause of death and the leading cause of malnutrition in children under five years old.1 

Diarrheal disease inflicts a significant toll on the health care system and imparts a high degree of morbidity and mortality in select populations. In 2010, the U.S. national bill for the 237,000+ patients suffering from gastrointestinal infections was over $6 billion.2 Due to similar symptoms it is difficult to differentiate among viral, bacterial and parasitic agents.  Hence, about 80% of all cases of diarrhea currently go unidentified, often resulting in inappropriate treatment.  It is both preventable and treatable. 

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. 

Simplify Your Detection Process
One test provides answers for 11 pathogens. Eliminate the hassle of managing multiple samples and testing methods. 

Optimize Your Resources
Minimize labor, reduce expenses, and improve overall laboratory and hospital efficiency.  

 

 Sources:

1 World Health Organization. Diarrhoeal Disease, Fact sheet N°330. August 2009. Available at: http://www.who.int/mediacentre/factsheets/fs330/en/index.html

2 U.S. Department of Health and Human Services. 2010 National Statistics on Intestinal Infections. Available from HCUPnet at: http://hcupnet.ahrq.gov/HCUPnet.jsp.

 
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.

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xTAG Gastrointestinal Pathogen Product Description 

The xTAG® Gastrointestinal Pathogen Panel (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.

Targets and Instrument Systems (Region-Specific Clearances)

[+] Targets and Instrument Systems

Clinical Performance

Contact your local Luminex representative for US Clinical Data 

[+] Multi-Site Clinical Summary for CE-marked product, IVD Europe

 

 

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.

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xTAG Gastrointestinal Pathogen Workflow

gpp-worflow-step1.jpg

Step 1: Extraction and Purification
Nucleic acid is extracted and purified from the pre-treated sample. Recommended extraction kits:

  • NucliSENS® easyMAG® (bioMerieux®) running Specific A 1.0.2 protocol
     

Time: 45 minutes*

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Step 2: Multiplex Amplification
Extracted nucleic acid is amplified in a single multiplex RT-PCR reaction.

Time: 2.5 hours*

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Step 3: Bead Hybridization and Detection
RT-PCR product is added to a hybridization/detection reaction containing the universal tag and Streptavidin, R-Phycoerythrin conjugate.

Time: 1 hour*

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Step 4: Data Acquisition & Analysis
Data acquisition and analysis is performed on the MAGPIX® or Luminex® 100/200™ instruments using TDAS.

Time: 10 minutes*

*Time estimate of within 5 hours is for a maximum of one extraction (24 samples), unless multiple extractors are available. Does not include pre-treatment.

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.

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Resources

Document Language Type Download
MSDS
     
MSDS (click to search database)      
Data Sheets and Brochures      
xTAG Gastrointestinal Pathogen Panel CE-IVD Brochure English pdf pdfImg download
xTAG Gastrointestinal Pathogen Panel Trading Cards (White Paper) English pdf pdfImg download
Posters 2012      
Etiology of acute diarrheal illness among patients visiting a cholera treatment center in Haiti using the xTAG gastrointestinal panel (GPP) assay- Charles; CVS 2012 English pdf pdfImg download
Evaluation of the Gastrointestinal Pathogen Panel (GPP) Assay- Chong; CVS 2012 English pdf pdfImg download
An Evaluation of the Luminex xTAG Gastrointestinal Pathogen Panel at a London teaching hospital- Bible; ECCMID 2012 English pdf pdfImg download
Use of a multiplex molecular assay for the detection of pathogens in stools from diarrheic patients - Izopet et al; ECCMID 2012 English pdf pdfImg download
First Italian Experience in the Clinical Practise of the Gastrointestinal Pathogen Panel Using A Unique Multiplexing Technology at the St.Orsola Hospital in Bologna- Vocale et al; ECCMID 2012 English pdf pdfImg download
Diagnosis of gastroenteric infections: comparison of traditional methods with the new molecular technologies - Marimón et al; ECCMID 2012 English pdf pdfImg download
Clinical performance of the xTAG Gastrointestinal Pathogen Panel, a multiplex molecular assay for detecting bacterial, viral, and parasitic causes of infectious gastroenteritis- Claas et al; ECCMID 2012 English pdf pdfImg download
Infectious gastroenteritis: evaluation of two multiplex-PCR assays- Viollier; ECCMID 2012 English pdf pdfImg download
Improvement of virological diagnosis of severe diarrhea in kidney transplant recipient using multiplex RT-PCR assays. N. Leveque - ESCV 2012 English pdf pdfImg download
Prospective application of the Luminex xTAG-GPP multiplex PCR in diagnosing infectious gastro-enteritis - Zlateva; ESCV 2012 English pdf pdfImg download
Posters 2011      
First experiences of the xTAG Gastrointestinal Pathogen Panel using the MAGPIX instrument English pdf pdfImg download
Rapid diagnostics from patients suspected to suffer from Norovirus infection reveals novel EHEC variant - Monica Malecki; ESCV 2011 English pdf pdfImg download
Prospective application of the Luminex xTAG-GPP multiplex PCR in diagnosing infectious gastro-enteritis - Dr. Claas; ECCMID 2011 English pdf pdfImg download
Clinical Performance Characteristics of the xTAG GPP: A Multi-Center Clinical Evaluation- Planet xMAP 2011 English pdf pdfImg download
Preliminary Evaluation of the xTAG GPP Multiplex Assay using the MAGPIX® Instrument - Dr. Mahony; CVS 2011 English pdf pdfImg download
Experience of a multiplex nucleic acid test for the detection of gastrointestinal pathogens in faecal samples - Dr. Blomberg; ECCMID 2011 English pdf pdfImg download
Presentations      
Rapid screening method for multiple gastro-enteric pathogens detects novel EHEC O104:H4 English pdf pdfImg download
Dr. Blomberg ECCMID 2011 English pdf pdfImg download
Dr. Claas ECCMID 2011 English pdf pdfImg download
Press      
Speeding Up Cholera Diagnosis; Laboratory News      
Luminex Used In E Coli Testing, Investors.com      
Multiplex PCR Test Identifies 15 Pathogens French pdf pdfImg download
Multiplex PCR Test Identifies 15 Pathogens Dutch pdf pdfImg download

 

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.

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Support Information

Luminex offers comprehensive technical support enabling companies and laboratories to perform clinical diagnosis quickly, accurately, and cost effectively while optimizing the customer experience with Luminex assays and systems.

Support Resources   Technical Support   Field Service
Target Values   Online Support Login   Certified Service Providers
    Email: [email protected]   Maintenance and Support

  Phone: 512-381-4397   Luminex Central Repair Facility

  Toll Free: 1-877-785-2323  
    International: + 800-2939-4959    

 

How To Videos

Chemistry  
xTAG GPP Chemistry Video 3:04 minutes
Demonstrations  
xTAG GPP PreTreatment Demonstration 7:57 minutes
xTAG GPP Extraction Demonstration 4:32 minutes

 

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.

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Ordering Information

Luminex Direct
Luminex Online Order Management
Email: [email protected]
Phone: 1-512-336-3550
Toll Free: 1-866-401-5450
Fax: 1-512-219-0544
Fax: 31-162-408330 (EMEA, India)

 

Product Name Kit Size Registration Status Catalog Number Available From
GPP Kit (US IVD) 96 Tests IVD-US I032C0316 Luminex
GPP Kit (EU/ROW IVD) 96 Tests CE-IVD Marked I032C0324 Luminex
xTAG Gastrointestinal Pathogen Panel (GPP) Kit Can Class III IVD 96 Tests IVD-Health Canada Licensed I032C0415 Luminex

 

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.

 

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