Gastroenteritis Clinical Trial
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
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.
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.
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Observational Model: Case-Only, Time Perspective: Prospective
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