A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay
Last updated on October 2021Recruitment
- Recruitment Status
- Unknown status
Inclusion Criteria
- 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.
- 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.
Exclusion Criteria
- 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 Criteria
- 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.
- 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.
Exclusion Criteria
- 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
- Indianapolis, Indiana, 46202
- Chapel Hill, North Carolina, 27599
- Los Angeles, California, 90049
- Aurora, Colorado, 13123
- Danville, Pennsylvania, 17822-0131
- ...
- Indianapolis, Indiana, 46202
- Chapel Hill, North Carolina, 27599
- Los Angeles, California, 90049
- Aurora, Colorado, 13123
- Danville, Pennsylvania, 17822-0131
Tracking Information
- NCT #
- NCT02092259
- Collaborators
- Not Provided
- Investigators
- Study Director: David Himsworth Luminex Corporation
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