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NCT02087761 Clinical Trial

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

Pneumonia Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data
NCT number NCT02087761
Other study ID # LMA-FLU-01-CS-001
Secondary ID
Status Active, not recruiting
Phase N/A
First received March 12, 2014
Last updated March 1, 2016
Start date December 2015

Study information
Verified date March 2016
Source Luminex Molecular Diagnostics
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

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).

Recruitment information / eligibility
Status Active, not recruiting
Enrollment 1000
Est. completion date
Est. primary completion date April 2016
Accepts healthy volunteers No
Gender Both
Age group N/A and older
Eligibility 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

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States North Shore-LIJ Health System Laboratories Lake Success New York
United States St. Louis Children's Hospital St. Louis Missouri
United States Baylor Scott & White Health Temple Texas

Sponsors (1)
Lead Sponsor Collaborator
Luminex Corporation

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement). 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. Within the first year of sample collection No
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