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

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01326013

Enrollment

1534

Registered

2011-03-30

Start date

2011-06-30

Completion date

2012-03-31

Last updated

2012-08-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colitis, Gastroenteritis, Infectious

Keywords

Stool, Feces, Gastrointestinal, Pathogen, Panel, xTAG GPP, Infectious colitis, Gastroenteritis, Detection

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Countries

Canada, United States

Outcome results