Gastroenteritis, Infectious Colitis
Conditions
Keywords
ARIES Clostridium difficile
Brief 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.
Detailed 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).
Interventions
None listed
Sponsors
Luminex Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* The specimen is from a patient suspected of having C. difficile associated disease (CDAD). * The subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted for testing at the site.
Exclusion criteria
* The specimen is preserved. * The specimen was not properly collected, transported, processed or stored according to the instructions provided by the sponsor.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Diagnostic accuracy will be a composite expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement). | Within the first year of sample collection |
Countries
United States
Outcome results
None listed