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Clinical Trial Summary

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.


Clinical Trial Description

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 Design


Related Conditions & MeSH terms


NCT number NCT02497417
Study type Observational
Source Luminex Molecular Diagnostics
Contact
Status Completed
Phase N/A
Start date October 2016
Completion date February 2017

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