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

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT02087761
First Posted: March 14, 2014
Last Update Posted: March 2, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Luminex Molecular Diagnostics ( Luminex Corporation )
  Purpose

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.


Condition
Respiratory Tract Infection Bronchitis Pneumonia

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: A Multi-Site Clinical Evaluation of the ARIES Flu Assay in Symptomatic Patients

Resource links provided by NLM:


Further study details as provided by Luminex Molecular Diagnostics ( Luminex Corporation ):

Primary Outcome Measures:
  • 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.


Biospecimen Retention:   Samples With DNA
Nasal-pharyngeal swabs

Estimated Enrollment: 1000
Study Start Date: December 2015
Estimated Primary Completion Date: April 2016 (Final data collection date for primary outcome measure)
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).

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
All comers
Criteria

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.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02087761


Locations
United States, Missouri
St. Louis Children's Hospital
St. Louis, Missouri, United States, 63119
United States, New York
North Shore‐LIJ Health System Laboratories
Lake Success, New York, United States, 11042
United States, Texas
Baylor Scott & White Health
Temple, Texas, United States, 76508
Sponsors and Collaborators
Luminex Corporation
Investigators
Study Director: David Himsworth Luminex Corporation
  More Information

Responsible Party: Luminex Corporation
ClinicalTrials.gov Identifier: NCT02087761     History of Changes
Other Study ID Numbers: LMA-FLU-01-CS-001
First Submitted: March 12, 2014
First Posted: March 14, 2014
Last Update Posted: March 2, 2016
Last Verified: March 2016

Keywords provided by Luminex Molecular Diagnostics ( Luminex Corporation ):
ARIES Flu

Additional relevant MeSH terms:
Pneumonia
Respiratory Tract Infections
Bronchitis
Lung Diseases
Respiratory Tract Diseases
Infection
Bronchial Diseases
Lung Diseases, Obstructive