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).
Study Type
OBSERVATIONAL
Enrollment
1,021
Tampa General Hospital
Tampa, Florida, United States
Indiana University Health
Indianapolis, Indiana, United States
TriCore Reference Laboratories
Albuquerque, New Mexico, United States
The Ohio State University
Columbus, Ohio, United States
Diagnostic accuracy will be a composite expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).
Time frame: Within the first year of sample collection
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