Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 12:35 PM
Ignite Modification Date:
2025-12-24 @ 12:35 PM
NCT ID:
NCT02087761
Brief Summary:
The ARIES Flu Assay is a real-time PCR based qualitative assay for the direct detection and differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens.
The objective of this study is to establish the diagnostic accuracy of ARIES Flu Assay.
Detailed Description:
The ARIES Flu Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection and differentiation of respiratory viral nucleic acid in nasopharyngeal swabs specimens from patients with signs and symptoms of respiratory tract infection in conjunction with clinical and laboratory findings.
The objective is to establish the diagnostic accuracy of ARIES Flu Assay through a multi-site, method comparison on prospectively collected, left-over, and de-identified, nasopharyngeal swab specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).
Study:
NCT02087761
Study Brief:
Protocol Section:
NCT02087761