NCT01326013

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,534 (actual)
• Sponsor: Luminex Molecular Diagnostics · Industry
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

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.

Conditions

• Infectious
• Colitis
• Gastroenteritis

Timeline

• Start date: 2011-06-01
• Primary completion: 2012-02-01
• Completion: 2012-03-01
• First posted: 2011-03-30
• Last updated: 2012-08-24

Locations

6 sites across 2 countries: United States, Canada