A Two-Arm, Multi-Centre Clinical Evaluation of the xTAG Gastrointestinal Pathogen Panel

A Two-Arm, Multi-Centre Clinical Evaluation of the xTAG Gastrointestinal Pathogen Panel (xTAG GPP) in Patients With Signs and Symptoms of Infectious Colitis and Gastroenteritis

The xTAG Gastrointestinal Pathogen Panel (xTAG GPP) is a PCR-based assay to detect the presence or absence of gastrointestinal (GI) pathogens from human stool specimens.

The objective of this study is to establish diagnostic accuracy of the xTAG GPP.

Study Overview

• Status: Completed
• Conditions: Gastroenteritis; Colitis; Infectious

Detailed Description

The xTAG GPP assay is a qualitative nucleic acid multiplex test intended to simultaneously detect and identify bacterial (and toxins), viral, and parasitic pathogens extracted from human stool specimens collected from patients with signs and symptoms of infectious colitis or gastroenteritis.

The objective of this study is to establish the diagnostic accuracy of xTAG GPP through a multi-site, method comparison study on prospectively collected, left-over, and anonymized stool specimens. The prospective sample set will also be supplemented with pre-selected archived left-over specimens (for low prevalence targets only). Diagnostic accuracy will be expressed in terms of clinical sensitivity and specificity for each target.

• Study Type: Observational
• Enrollment (Actual): 1534

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Hamilton, Ontario, Canada, L8N 4A6
      • St. Joseph's Hospital
    • Toronto, Ontario, Canada, M5G 1X5
      • Mount Sinai Hospital
• United States
  • Arizona
    • Tucson, Arizona, United States
      • University of Arizona
  • Missouri
    • St. Louis, Missouri, United States
      • St. Louis Children's Hospital
  • Tennessee
    • Nashville, Tennessee, United States
      • Vanderbilt University Medical Centre
  • Texas
    • Temple, Texas, United States, 76508
      • Scott and White Memorial Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Clinical specimens collected from patients with signs and symptoms of infectious colitis or gastroenteritis who are either hospitalized, admitted to emergency departments or visiting outpatient clinics.

Description

Inclusion Criteria:

• The specimen is stool.
• The specimen is from a pediatric or adult, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long-term care facility.
• The specimen is from a patient exhibiting clinical signs and symptoms of infectious colitis or gastroenteritis.

Exclusion Criteria:

• The specimen is a preserved stool, stool in Cary-Blair media or rectal swab.

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Blinded, Pre-selected Arm; For targets that exhibit lower prevalence rates in the intended use population, banked, pre-selected, positive clinical specimens will be tested.
Blinded, Prospective Arm; Diagnostic accuracy for higher prevalence targets will be evaluated in prospectively collected, anonymized, leftover, stool specimens.

Collaborators and Investigators

• Sponsor: Luminex Molecular Diagnostics
• Investigators: Study Director: Jeremy Liu, Ph.D, Luminex Molecular Diagnostics; Principal Investigator: Tony Mazzulli, M.D., F.R.C.P.(C), FACP, Mount Sinai Hospital; Principal Investigator: Robert C. Fader, Ph.D, Scott and White Hospital & Clinic; Principal Investigator: James Mahony, Ph.D, FCCM, FAAM, St. Joseph's Hospital; Principal Investigator: Yi-Wei Tang, M.D., Ph.D, Vanderbilt University Medical Centre; Principal Investigator: Richard Buller, Ph.D., D(ABMM), St. Louis Children's Hospital; Principal Investigator: Donna M. Wolk, Ph.D., D.(ABMM), University of Arizona

Study record dates

Study Major Dates

• Study Start: June 1, 2011
• Primary Completion (Actual): February 1, 2012
• Study Completion (Actual): March 1, 2012

Study Registration Dates

• First Submitted: March 29, 2011
• First Submitted That Met QC Criteria: March 29, 2011
• First Posted (Estimate): March 30, 2011

Study Record Updates

• Last Update Posted (Estimate): August 24, 2012
• Last Update Submitted That Met QC Criteria: August 22, 2012
• Last Verified: August 1, 2012

More Information

Terms related to this study

• Keywords: Detection; Gastroenteritis; Gastrointestinal; Stool; Panel; Feces; Infectious colitis; Pathogen; xTAG GPP
• Additional Relevant MeSH Terms: Digestive System Diseases; Pathologic Processes; Disease Attributes; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases; Infections; Communicable Diseases; Gastroenteritis; Colitis
• Other Study ID Numbers: TDP-736-189