A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay

A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay in Patients With Signs and Symptoms of Acute Gastroenteritis

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

The purpose of this study is to establish the diagnostic accuracy of 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.