A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay

Status unconfirmed

Conditions studied: Acute Gastroenteritis

In brief

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.

Key facts

Study ID

NCT02092259

Run by

Luminex Corporation

People needed

500

Starts

2014-01-01

Last updated by the study team

2015-07-14

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• UCLA — Los Angeles, California, United States (enrolling)
• Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
• Indiana Health — Indianapolis, Indiana, United States (enrolling)
• University of North Carolina at Chapel Hill — Chapel Hill, North Carolina, United States (enrolling)
• Geisinger Medical Laboratories — Danville, Pennsylvania, United States (enrolling)

Full record on ClinicalTrials.gov

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