A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay

Acute Gastroenteritis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02092259
• Other study ID #: LMA-NOR-01-CS-001
• Status: Recruiting
• Phase: N/A
• First received: March 17, 2014
• Last updated: July 10, 2015
• Start date: January 2014

Study information

• Verified date: June 2015
• Source: Luminex Molecular Diagnostics
• Contact: Ian Ridd
• Email: iridd[@]luminexcorp.com
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 500
• Est. primary completion date: December 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Acute Gastroenteritis
• Gastroenteritis

Locations

Country	Name	City	State
United States	Children's Hospital Colorado	Aurora	Colorado
United States	University of North Carolina at Chapel Hill	Chapel Hill	North Carolina
United States	Geisinger Medical Laboratories	Danville	Pennsylvania
United States	Indiana Health	Indianapolis	Indiana
United States	UCLA	Los Angeles	California

Sponsors (1)

Lead Sponsor	Collaborator
Luminex Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).	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.	Within the first year of sample collection	No