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

Completed

• Conditions: Colitis; Gastroenteritis; Infectious

• Registration Number: NCT01326013
• Lead Sponsor: Luminex Molecular Diagnostics

Brief Summary

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.

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 Timeline

• Study First Submitted: 2011-03-29
• Study First Submitted QC: 2011-03-29
• Study First Posted: 2011-03-30
• Study Start: 2011-06
• Primary Completion: 2012-02
• Study Completion: 2012-03
• Status Verified: 2012-08
• Last Update Submitted: 2012-08-22
• Last Update Posted: 2012-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1534

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (6)

University of Arizona; 🇺🇸 Tucson, Arizona, United States

St. Louis Children's Hospital; 🇺🇸 St. Louis, Missouri, United States

Vanderbilt University Medical Centre; 🇺🇸 Nashville, Tennessee, United States

Scott and White Memorial Hospital; 🇺🇸 Temple, Texas, United States

St. Joseph's Hospital; 🇨🇦 Hamilton, Ontario, Canada

Mount Sinai Hospital; 🇨🇦 Toronto, Ontario, Canada