Gastroenteritis Clinical Trial
Official title:
A Multi-Site Clinical Evaluation of the ARIES Clostridium Difficile Assay in Symptomatic Patients
The ARIES C. difficile Assay is a real-time PCR based qualitative in vitro diagnostic test for the direct detection of C. difficile nucleic acid in stool specimens.
The ARIES C. difficile Assay is a real-time polymerase chain reaction (PCR) based qualitative
in vitro diagnostic test for the direct detection of Clostridium difficile (C. difficile)
nucleic acid in unformed (liquid or soft) stool specimens obtained from patients suspected of
having Clostridium difficile associated disease (CDAD).
The objective of this study is to establish diagnostic accuracy of ARIES C. difficile Assay
through a multi-site, method comparison on prospectively collected, left-over, stool
specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or
positive agreement) and specificity (or negative agreement).
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