Recruiting

ARIES Norovirus Assay

Sponsor:

Luminex Corporation

Code:

NCT02092259

Conditions

Acute Gastroenteritis

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Acute Gastroenteritis

Study ID

NCT02092259

Start date

Jan, 2014

Status verified date

Jun, 2015

Primary completion date

Dec, 2015

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 0+

Healthy Volunteers: Not accepted

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

Enrollment

500 participants

Anticipated

Interventions and Outcome Measures

Primary outcome measure

  • 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 ]

Central Contacts and Locations

Central contacts

Ian Ridd

iridd@luminexcorp.com

Locations

UCLA

Recruiting

Los Angeles, California, United States, 90049

Contacts

Janet Hindler

jhindler@mednet.ucla.edu

Principal Investigator:

Romney Humphries, Ph.D

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 13123

Contacts

C. Robinson

Christine.Robinson@childrenscolorado.org

Principal Investigator:

Christine Robinson, Ph.D

Indiana Health

Recruiting

Indianapolis, Indiana, United States, 46202

Contacts

Kristin Post

kpost@iuhealth.org

Principal Investigator:

Liang Cheng, MD

University of North Carolina at Chapel Hill

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Elena Popowitch

elena.popowitch@unchealth.unc.edu

Principal Investigator:

Melissa Miller, Ph.D

Geisinger Medical Laboratories

Recruiting

Danville, Pennsylvania, United States, 17822-0131

Contacts

D. Hernandez

drhernandez@geisinger.edu

Principal Investigator:

Donna M Wolk, Ph.D.,D(ABMM)

More Information

Sponsor

Luminex Corporation

Last update posted

Jul 14, 2015

Last verified

Jun, 2015

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Luminex Corporation on 2015-07-14.