Overview

This trial is active, not recruiting.

Conditions respiratory tract infection, bronchitis, pneumonia
Sponsor Luminex Corporation
Start date December 2015
End date April 2016
Trial size 1000 participants
Trial identifier NCT02087761, LMA-FLU-01-CS-001

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Observational model case-only
Time perspective prospective

Primary Outcomes

Measure
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

Eligibility Criteria

Male or female participants of any age.

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.

Additional Information

Official title A Multi-Site Clinical Evaluation of the ARIES Flu Assay in Symptomatic Patients
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).
Trial information was received from ClinicalTrials.gov and was last updated in March 2016.
Information provided to ClinicalTrials.gov by Luminex Molecular Diagnostics.