NCT02087761

Brief 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.

Trial Health

55
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,000

participants targeted

Target at P75+ for all trials

Geographic Reach
1 country

3 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 12, 2014

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 14, 2014

Completed
1.7 years until next milestone

Study Start

First participant enrolled

December 1, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2016

Completed
Last Updated

March 2, 2016

Status Verified

March 1, 2016

Enrollment Period

4 months

First QC Date

March 12, 2014

Last Update Submit

March 1, 2016

Conditions

Respiratory Tract InfectionBronchitisPneumonia

Keywords

ARIES Flu

Outcome Measures

Primary Outcomes (1)

  • 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

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All comers

You may qualify if:

  • 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

You may not qualify if:

  • The specimen is NOT a nasopharyngeal swab
  • The specimen was not properly collected, transported or stored according to the instructions provided by the sponsor.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

St. Louis Children's Hospital

St Louis, Missouri, 63119, United States

Location

North Shore-LIJ Health System Laboratories

Lake Success, New York, 11042, United States

Location

Baylor Scott & White Health

Temple, Texas, 76508, United States

Location

Biospecimen

Retention: SAMPLES WITH DNA

Nasal-pharyngeal swabs

MeSH Terms

Conditions

Respiratory Tract InfectionsBronchitisPneumonia

Condition Hierarchy (Ancestors)

InfectionsRespiratory Tract DiseasesBronchial DiseasesLung Diseases, ObstructiveLung Diseases

Study Officials

  • David Himsworth

    Luminex Corporation

    STUDY DIRECTOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 12, 2014

First Posted

March 14, 2014

Study Start

December 1, 2015

Primary Completion

April 1, 2016

Last Updated

March 2, 2016

Record last verified: 2016-03

Locations

US(3)