A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay

The ARIES Norovirus Assay is a real-time polymerase chain reaction (PCR) based qualitative
in vitro diagnostic test for the direct detection of Norovirus GI/GII RNA from stool
specimens obtained from symptomatic patients.

The objective is to establish the diagnostic accuracy of the ARIES Norovirus assay through a
multi-site, method comparison on prospectively collected leftover, 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 with symptoms of acute gastroenteritis.

- The specimen is from a male or female subject who was either hospitalized, admitted
to a hospital emergency department or visiting an outpatient clinic.

- The subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted
for testing at the site.

Exclusion Criteria:

- The specimen is from an individual with known and documented non-infectious
conditions such as ulcerative colitis, irritable bowel syndrome and/or Crohn's
disease

- The specimen was not properly collected, transported, processed or stored according
to the instructions provided by the sponsor.