A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay

July 10, 2015 updated by: Luminex Corporation

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

500

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • California
      • Los Angeles, California, United States, 90049
    • Colorado
    • Indiana
      • Indianapolis, Indiana, United States, 46202
        • Recruiting
        • Indiana Health
        • Contact:
        • Principal Investigator:
          • Liang Cheng, MD
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • Recruiting
        • University of North Carolina at Chapel Hill
        • Contact:
        • Principal Investigator:
          • Melissa Miller, Ph.D
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-0131
        • Recruiting
        • Geisinger Medical Laboratories
        • Contact:
        • Principal Investigator:
          • Donna M Wolk, Ph.D.,D(ABMM)

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All comers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).
Time Frame: 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.
Within the first year of sample collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luminex Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2014

Primary Completion (ANTICIPATED)

December 1, 2015

Study Registration Dates

First Submitted

March 17, 2014

First Submitted That Met QC Criteria

March 17, 2014

First Posted (ESTIMATE)

March 20, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

July 14, 2015

Last Update Submitted That Met QC Criteria

July 10, 2015

Last Verified

June 1, 2015

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMA-NOR-01-CS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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