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
• 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. 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

• Bronchitis
• Pneumonia
• Respiratory Tract Infection
• Respiratory Tract Infections

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