A Two-Arm, Multi-Centre Clinical Evaluation of the xTAG Gastrointestinal Pathogen Panel
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 Design:||Observational Model: Case-Only
Time Perspective: Prospective
|Official Title:||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|
|Study Start Date:||June 2011|
|Study Completion Date:||March 2012|
|Primary Completion Date:||February 2012 (Final data collection date for primary outcome measure)|
Blinded, Prospective Arm
Diagnostic accuracy for higher prevalence targets will be evaluated in prospectively collected, anonymized, leftover, stool specimens.
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.
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.
|United States, Arizona|
|University of Arizona|
|Tucson, Arizona, United States|
|United States, Missouri|
|St. Louis Children's Hospital|
|St. Louis, Missouri, United States|
|United States, Tennessee|
|Vanderbilt University Medical Centre|
|Nashville, Tennessee, United States|
|United States, Texas|
|Scott and White Memorial Hospital|
|Temple, Texas, United States, 76508|
|St. Joseph's Hospital|
|Hamilton, Ontario, Canada, L8N 4A6|
|Mount Sinai Hospital|
|Toronto, Ontario, Canada, M5G 1X5|
|Study Director:||Jeremy Liu, Ph.D||Luminex Molecular Diagnostics|
|Principal Investigator:||Tony Mazzulli, M.D., F.R.C.P.(C), FACP||Mount Sinai Hospital, New York|
|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|