Sample Collection to Evaluate an Investigational Instrument for the Detection of Respiratory Viruses in Nasopharyngeal Swabs

Completed

• Conditions: Viral Respiratory Infection

• Registration Number: NCT01806285
• Lead Sponsor: GenMark Diagnostics

Brief Summary

The purpose of this sample collection study is to prospectively collect respiratory viral clinical samples, conduct standard of care comparator testing and archive the collected residual samples for future testing in order to establish the clinical performance characteristics of the investigational instrument.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-02
• Study First Submitted: 2013-02-26
• Study First Submitted QC: 2013-03-06
• Study First Posted: 2013-03-07
• Primary Completion: 2014-05
• Study Completion: 2015-11
• Status Verified: 2015-12
• Last Update Submitted: 2015-12-23
• Last Update Posted: 2015-12-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 205

Inclusion Criteria

• The specimen is a nasopharyngeal swab.
• The specimen is from a pediatric or adult male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinic or resident of a long term care facility.
• The specimen is from a patient exhibiting clinical signs and symptoms of respiratory tract infection such as fever, sore throat, shortness of breath, bronchitis, bronchiolitis, and pneumonia.

Exclusion Criteria

• The specimen is not a nasopharyngeal swab.
• The specimen is from an individual who does not exhibit clinical signs and symptoms of respiratory tract infection.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sample collection study only	prospective sample collection