A Multi-Site Clinical Evaluation of the ARIES Norovirus Assay

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT02092259

Enrollment

500

Registered

2014-03-20

Start date

2014-01-31

Completion date

Unknown

Last updated

2015-07-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Gastroenteritis

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.

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)

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).	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.

Countries

United States

Contacts

Primary ContactIan Ridd

iridd@luminexcorp.com

Outcome results