Status:

COMPLETED

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

Lead Sponsor:

GenMark Diagnostics

Conditions:

Viral Respiratory Infection

Eligibility:

All Genders

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 f...

Eligibility Criteria

Inclusion

  • 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

  • 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.

Key Trial Info

Start Date :

February 1 2013

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 1 2015

Estimated Enrollment :

205 Patients enrolled

Trial Details

Trial ID

NCT01806285

Start Date

February 1 2013

End Date

November 1 2015

Last Update

December 28 2015

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