A Multi-Site Clinical Evaluation of the ARIES Flu Assay in Symptomatic Patients

• Conditions: Pneumonia; Respiratory Tract Infection; Bronchitis

• Registration Number: NCT02087761
• Lead Sponsor: Luminex Corporation

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 Timeline

• Study First Submitted: 2014-03-12
• Study First Submitted QC: 2014-03-12
• Study First Posted: 2014-03-14
• Study Start: 2015-12
• Status Verified: 2016-03
• Last Update Submitted: 2016-03-01
• Last Update Posted: 2016-03-02
• Primary Completion: 2016-04

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1000

Inclusion Criteria

• The specimen is from a patient suspected of having respiratory tract infection for whom a requisition has been made for viral testing
• The specimen is from a male of female subject who was either hospitalized, admitted to a hospital emergency department or visiting an outpatient clinic.
• The specimen is a nasopharyngeal swab

Exclusion Criteria

• The specimen is NOT a nasopharyngeal swab
• The specimen was not properly collected, transported or stored according to the instructions provided by the sponsor.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Flu assay.

Trial Locations

Locations (3)

Baylor Scott & White Health; 🇺🇸 Temple, Texas, United States

St. Louis Children's Hospital; 🇺🇸 St. Louis, Missouri, United States

North Shore-LIJ Health System Laboratories; 🇺🇸 Lake Success, New York, United States