Last updated on July 2015

A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay


Brief description of study

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.

Detailed Study Description

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)

Clinical Study Identifier: NCT02092259

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Romney Humphries, Ph.D

UCLA
Los Angeles, CA United States
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Christine Robinson, Ph.D

Children's Hospital Colorado
Aurora, CO United States
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Liang Cheng, MD

Indiana Health
Indianapolis, IN United States
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Melissa Miller, Ph.D

University of North Carolina at Chapel Hill
Chapel Hill, NC United States
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Donna M Wolk, Ph.D.,D(ABMM)

Geisinger Medical Laboratories
Danville, PA United States
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