Recruitment

Recruitment Status
Unknown status

Inclusion Criterias

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 specimen is from a patient with symptoms of acute gastroenteritis.
The subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted for testing at the site.
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 specimen is from a patient with symptoms of acute gastroenteritis.
The subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted for testing at the site.

Exclusion Criterias

The specimen was not properly collected, transported, processed or stored according to the instructions provided by the sponsor.
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.
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

Summary

Conditions
Acute Gastroenteritis
Type
Observational
Design
  • Observational Model: Case-Only
  • Time Perspective: Prospective

Participation Requirements

Age
Younger than 125 years
Gender
Both males and females

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 a...

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)

Inclusion Criterias

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 specimen is from a patient with symptoms of acute gastroenteritis.
The subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted for testing at the site.
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 specimen is from a patient with symptoms of acute gastroenteritis.
The subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted for testing at the site.

Exclusion Criterias

The specimen was not properly collected, transported, processed or stored according to the instructions provided by the sponsor.
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.
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

Locations

Danville, Pennsylvania, 17822-0131
Aurora, Colorado, 13123
Chapel Hill, North Carolina, 27599
Los Angeles, California, 90049
Indianapolis, Indiana, 46202
...
Danville, Pennsylvania, 17822-0131
Aurora, Colorado, 13123
Chapel Hill, North Carolina, 27599
Los Angeles, California, 90049
Indianapolis, Indiana, 46202

Tracking Information

NCT #
NCT02092259
Collaborators
Not Provided
Investigators
Study Director: David Himsworth Luminex Corporation