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

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).

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.