Acute Gastroenteritis Clinical Trial
Official title:
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.
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)
;
Observational Model: Case-Only, Time Perspective: Prospective
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