An observational study in Gastroenteritis and Infectious Colitis, sponsored by Luminex Corporation. Completed at 4 sites in United States. Per ClinicalTrials.gov, last updated 2017-08-23.
Sponsored by Luminex Corporation · Observational
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).
243 studies on the registry are indexed under Gastroenteritis; 15 are open to participants now.
This study's enrollment of 1,021 is above the median of 611 across 71 observational studies indexed under Gastroenteritis.
Browse Gastroenteritis studies →Luminex Corporation is the lead sponsor of 7 studies on the registry; none are open to participants now.
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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
This study is completed, as verified in Aug 2017. You cannot join it, but the record below documents what was studied.
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Luminex Corporation