A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay

• Conditions: Acute Gastroenteritis

• Registration Number: NCT02092259
• Lead Sponsor: Luminex Corporation

Brief Summary

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 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)

Study Timeline

• Study Start: 2014-01
• Study First Submitted: 2014-03-17
• Study First Submitted QC: 2014-03-17
• Study First Posted: 2014-03-20
• Status Verified: 2015-06
• Last Update Submitted: 2015-07-10
• Last Update Posted: 2015-07-14
• Primary Completion: 2015-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).	Within the first year of sample collection	Accuracy determinations (diagnostic sensitivity and specificity, positive and negative agreement) were based on the fraction of comparator positive (or negative) results which were also positive (or negative) by ARIES Norovirus Assay.

Trial Locations

Locations (5)

UCLA; 🇺🇸 Los Angeles, California, United States

Geisinger Medical Laboratories; 🇺🇸 Danville, Pennsylvania, United States

Children's Hospital Colorado; 🇺🇸 Aurora, Colorado, United States

University of North Carolina at Chapel Hill; 🇺🇸 Chapel Hill, North Carolina, United States

Indiana Health; 🇺🇸 Indianapolis, Indiana, United States