A Multi-Site Clinical Evaluation of the ARIES Flu Assay in Symptomatic Patients
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|ClinicalTrials.gov Identifier: NCT02087761|
Recruitment Status : Unknown
Verified March 2016 by Luminex Molecular Diagnostics ( Luminex Corporation ).
Recruitment status was: Active, not recruiting
First Posted : March 14, 2014
Last Update Posted : March 2, 2016
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.
|Condition or disease|
|Respiratory Tract Infection Bronchitis Pneumonia|
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 Type :||Observational|
|Estimated Enrollment :||1000 participants|
|Official Title:||A Multi-Site Clinical Evaluation of the ARIES Flu Assay in Symptomatic Patients|
|Study Start Date :||December 2015|
|Estimated Primary Completion Date :||April 2016|
- Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement). [ Time Frame: 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 Flu assay.
Biospecimen Retention: Samples With DNA
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087761
|United States, Missouri|
|St. Louis Children's Hospital|
|St. Louis, Missouri, United States, 63119|
|United States, New York|
|North Shore‐LIJ Health System Laboratories|
|Lake Success, New York, United States, 11042|
|United States, Texas|
|Baylor Scott & White Health|
|Temple, Texas, United States, 76508|
|Study Director:||David Himsworth||Luminex Corporation|