xTAG^® Gastrointestinal Pathogen Panel (xTAG GPP)

Gastroenteritis Is A Serious Global Problem

Globally, there are an estimated two billion cases of diarrheal disease every year which kills approximately 1.8 million people yearly. Diarrheal disease is the second leading cause of death and 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. Due to similar symptoms it is difficult to differentiate among viral, bacterial and parasitic agents; hence, 80% of all cases of diarrhea are currently unidentified, and antibiotics are often inappropriately used.²  It is both preventable and treatable.

Transforming GI Diagnostics

The xTAG GPP is the first diagnostic to offer detection of 15 major gastrointestinal pathogens in a single test:

• Results within 5 hours for timely and better patient care
• Fast turn-around time and multiplex testing mean better use of time and human resources
• Multiplexed molecular testing for a reliable, actionable result

xTAG GPP Introduction Video

How Does It Work?

• A single multiplex RT-PCR step amplifies nucleic acids from all three pathogen types: bacterial, viral and parasitic
• Detection is performed using the award-winning xTAG universal tag sorting system on the simple, reliable, and affordable MAGPIX^® and proven Luminex^® 100/200™ instruments.

Pathogens Included In The Panel

Sources:
¹ Source: http://www.who.int/mediacentre/factsheets/fs330/en/index.html
² Source: CDC, National Center for Zoonotic, Vector-borne and Enteric Diseases

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at support@luminexcorp.com to obtain the appropriate product information for your country of residence.

xTAG Gastrointestinal Pathogen Product Description 

Multiplexed molecular testing for a reliable, actionable result in under 5 hours

• xTAG GPP is the only test that simultaneously detects and identifies the bacterial, viral, and parasitic pathogens responsible for over 95% of cases of infectious diarrhea¹
• xTAG GPP provides:
  
  • More answers per sample than any other method
  • A reliable answer, in time to affect patient care
  • Better use of time and human resources

xTAG GPP – More results per test than any other method, in time to affect patient care

 Pinpoint the cause of gastrointestinal infections quickly and efficiently

• A single multiplex RT-PCR step amplifies nucleic acids from all three pathogen types: bacterial, viral and parasitic.
• Detection is performed using the award-winning xTAG universal tag sorting system on the simple, reliable, and affordable MAGPIX^® and proven Luminex^® 100/200™ instruments, both CE marked

Enable timely, informed treatment decisions for all diarrhea patients

• xTAG GPP is indicated for use in⁵:
  • All patients with signs and symptoms of infectious gastroenteritis or colitis
  • Acute and chronic diarrhea
  • Inpatient, outpatient and emergency settings
  • Nosocomial surveillance

Get answers you can rely on with a validated, sensitive and specific assay

• Validated and quality controlled (cGMP) reagents that comply with regulatory requirements (CE-IVD) so you can operationalize quickly and efficiently
• Results you can rely on – high sensitivity and specificity for all the target pathogens

xTAG GPP – Excellent sensitivity and specificity performance for all targets⁵ assessed with MAGPIX

References: 1. CDC, National Center for Zoonotic, Vector-borne and Enteric Diseases. 2. Slutsker L et al. Annals of Internal Medicine 1997; 126(7):505–513. 3. Fotedar R et al. Journal of Clinical Microbiology 2007; 45(3):1035–1037. 4. Tuncay S et al. Türkiye Parazitoloji Dersigi 2007; 31(3):188–193. 5. Luminex Corporation. xTAG® Gastrointestinal Pathogen Panel (GPP) Package Insert. 

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at support@luminexcorp.com to obtain the appropriate product information for your country of residence.

xTAG Gastrointestinal Pathogen Workflow

How the xTAG Gastrointestinal Pathogen Panel works:

	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 1.2.0 protocol QIAamp® MinElute® Virus Spin kit (Qiagen® Cat. No. 57704) Time: 45 minutes*
	Step 2: Multiplex Amplification Extracted nucleic acid is amplified in a single multiplex RT-PCR reaction. Time: 2.5 hours*
	Step 3: Bead Hybridization and Detect RT-PCR product is added to a hybridization/detection reaction containing the universal tag and Streptavidin, R-Phycoerythrin conjugate. Time: 1 hour*
	Step 4: Data Acquisition & Analysis Data acquisition and analysis is performed on the MAGPIX® or Luminex® 100/200™ instruments using TDAS. Time: 20 minutes*

 *Time estimates for 24 samples.

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at support@luminexcorp.com to obtain the appropriate product information for your country of residence.

Downloads

Document	Language	Type	Download
MSDS
MSDS (click to search database)
Data Sheets and Brochures
xTAG Gastrointestinal Pathogen Panel Brochure	English	pdf
xTAG Gastrointestinal Pathogen Panel Trading Cards (White Paper)	English	pdf
Posters
First experiences of the xTAG Gastrointestinal Pathogen Panel using the MAGPIX instrument	English	pdf
Rapid diagnostics from patients suspected to suffer from Norovirus infection reveals novel EHEC variant - Monica Malecki; ESCV 2011	English	pdf
Prospective application of the Luminex xTAG-GPP multiplex PCR in diagnosing infectious gastro-enteritis - Dr. Claas; ECCMID 2011	English	pdf
Clinical Performance Characteristics of the xTAG GPP: A Multi-Center Clinical Evaluation- Planet xMAP 2011	English	pdf
Prospective application of the Luminex xTAG-GPP multiplex PCR in diagnosing infectious gastro-enteritis - Dr. Claas; ECCMID 2011	English	pdf
Preliminary Evaluation of the xTAG GPP Multiplex Assay using the MAGPIX® Instrument - Dr. Mahony; CVS 2011	English	pdf
Experience of a multiplex nucleic acid test for the detection of gastrointestinal pathogens in faecal samples - Dr. Blomberg; ECCMID 2011	English	pdf
Presentations
Rapid screening method for multiple gastro-enteric pathogens detects novel EHEC O104:H4	English	pdf
Dr. Blomberg ECCMID 2011	English	pdf
Dr. Claas ECCMID 2011	English	pdf
Press
Speeding Up Cholera Diagnosis; Laboratory News
Luminex Used In E Coli Testing, Investors.com
Multiplex PCR Test Identifies 15 Pathogens	French	pdf
Multiplex PCR Test Identifies 15 Pathogens	Dutch	pdf

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at support@luminexcorp.com to obtain the appropriate product information for your country of residence.

xTAG Gastrointestinal Pathogen Training Courses

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at support@luminexcorp.com to obtain the appropriate product information for your country of residence.

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.

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at support@luminexcorp.com to obtain the appropriate product information for your country of residence.

Ordering Information

For In Vitro Diagnostic Use. Products are region specific and may not be approved in some countries/regions. Please contact Luminex at support@luminexcorp.com to obtain the appropriate product information for your country of residence.