FDA-cleared.

xTAG® Gastrointestinal Pathogen Panel (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 14 common 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.

U.S. IVD Intended Use: 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.

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xTAG Gastrointestinal Pathogen Product Description 

The only highly-scalable gastrointestinal molecular test with customizable detection of bacterial, viral and parasitic pathogens to rule out infectious diarrhea. xTAG GPP has been validated on both raw stool and Cary-Blair media clinical specimens.

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 on Luminex® 100/200™ system

 

 

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.

U.S. IVD Intended Use: 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.

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xTAG Gastrointestinal Pathogen Workflow

GPP Workflow

** Time estimate of approximately 5 hours is for a maximum of one extraction (24 samples)

The Luminex 100/200 is a class 1(I) laser product.

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.

U.S. IVD Intended Use: 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.

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Resources

Document Language Type Download
Clinical Utility      
Microbiological diagnosis of severe diarrhea in kidney transplant recipients using multiplex PCR assays. Journal of Clinical Microbiology, ePub April 3, 2013; doi:10.1128/JCM.03366-12 English Article  

[+] Click to review more

Analytical Performance      
Performance of the xTAG® Gastrointestinal Pathogen Panel (GPP), a multiplex molecular assay for simultaneous detection of bacterial, viral and parasitic causes of infectious gastroenteritis English pdf pdfImg download

[+] Click to review more

Economic Impact      
Highly multiplexed testing for infectious diarrhoea: A service evaluation study of the Luminex Gastrointestinal Pathogen Panel (GPP) English pdf pdfImg download

[+] Click to review more

MSDS
     
MSDS (click to search database)      
Press      
Luminex Corporation Receives U.S. FDA Clearance for MAGPIX® Instrument with Novel xTAG® Gastrointestinal Pathogen Panel      
Luminex Receives FDA Clearance for First Comprehensive Gastrointestinal Pathogen Infectious Disease Diagnostic in the United States      
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.

U.S. IVD Intended Use: 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.

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xTAG Gastrointestinal Pathogen Training Courses

At Luminex Learning, we offer online, live online, and classroom training options. To view a list of our course offerings, or to enroll in a course, please visit our training page.

 

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.

U.S. IVD Intended Use: 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.

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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.

U.S. IVD Intended Use: 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.

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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(0)73 800 1998 (EMEA, India)

 

Product Name Kit Size Registration Status Catalog Number Available From
GPP Kit (US IVD) 96 Tests FDA cleared I032C0316 Luminex
GPP Kit (EU IVD) 96 Tests CE Marked I032C0324 Luminex
xTAG Gastrointestinal Pathogen Panel (GPP) Kit Can Class III IVD 96 Tests Health Canada Licensed I032C0415 Luminex
Bertin SK38 Soil Grinding Lysis Bead Tubes 100 Tubes General Purpose Reagent GR032C0442 Luminex*
* May only be sold with purchase of an xTAG GPP kit. Product not sold separately.

 

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.

U.S. IVD Intended Use: 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.

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