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

March 1, 2016 updated by: Luminex Corporation

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.

Study Overview

Status

Unknown

Conditions

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 Type

Observational

Enrollment (Anticipated)

1000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • St. Louis, Missouri, United States, 63119
        • St. Louis Children's Hospital
    • New York
      • Lake Success, New York, United States, 11042
        • North Shore-LIJ Health System Laboratories
    • Texas
      • Temple, Texas, United States, 76508
        • Baylor Scott & White Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

All comers

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Within the first year of sample collection

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Luminex Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

April 1, 2016

Study Registration Dates

First Submitted

March 12, 2014

First Submitted That Met QC Criteria

March 12, 2014

First Posted (Estimate)

March 14, 2014

Study Record Updates

Last Update Posted (Estimate)

March 2, 2016

Last Update Submitted That Met QC Criteria

March 1, 2016

Last Verified

March 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LMA-FLU-01-CS-001

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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