A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay



Status:Recruiting
Conditions:Gastrointestinal
Therapuetic Areas:Gastroenterology
Healthy:No
Age Range:Any
Updated:4/21/2016
Start Date:January 2014
Contact:Ian Ridd
Email:iridd@luminexcorp.com

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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.
We found this trial at
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Danville, Pennsylvania 17822
Principal Investigator: Donna M Wolk, Ph.D.,D(ABMM)
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Chapel Hill, North Carolina 27599
(919) 962-2211
Principal Investigator: Melissa Miller, Ph.D
University of North Carolina at Chapel Hill Carolina’s vibrant people and programs attest to the...
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13123 E 16th Ave
Aurora, Colorado 80045
(720) 777-1234
Principal Investigator: Christine Robinson, Ph.D
Children's Hospital Colorado At Children's Hospital Colorado, we see more, treat more and heal more...
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Indianapolis, Indiana 46202
Principal Investigator: Liang Cheng, MD
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Indianapolis, IN
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Los Angeles, California 90095
(310) 825-4321
Principal Investigator: Romney Humphries, Ph.D
UCLA UCLA's primary purpose as a public research university is the creation, dissemination, preservation and...
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Los Angeles, CA
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