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

Status unconfirmed

Conditions studied: Respiratory Tract Infection, Bronchitis, Pneumonia

In brief

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.

Key facts

Study ID

NCT02087761

Run by

Luminex Corporation

People needed

1000

Starts

2015-12-01

Last updated by the study team

2016-03-02

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

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

Full record on ClinicalTrials.gov

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