A Multi-Site Clinical Evaluation of the ARIES Clostridium Difficile Assay in Symptomatic Patients

Luminex

Status: Completed

Conditions: Infectious Colitis; Gastroenteritis

Study type: Observational

Funder types: Industry

Identifiers

NCT02497417

LMA-CDF-01-CS-001

Details and patient eligibility

About

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.

Full 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).

Enrollment: 1,021 patients

Sex: All

Volunteers: No Healthy Volunteers

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.