Status:
TERMINATED
Clinical Validation of the Point-of-Care MSD Influenza Test
Lead Sponsor:
Meso Scale Diagnostics, LLC.
Collaborating Sponsors:
Centers for Disease Control and Prevention
Conditions:
Influenza Human
Eligibility:
All Genders
Brief Summary
The primary objective of this study is to evaluate the performance of the MSD® Influenza Test in detecting influenza A and influenza B in subjects presenting with influenza-like-illness (ILI).
Detailed Description
This is a multicenter, prospective study to evaluate the performance of the MSD Influenza Test for the detection and differentiation of influenza A (including A/H1, A/H3, and A/H5 subtypes) and influe...
Eligibility Criteria
Inclusion
- Any subject (all ages) presenting with ILI (defined as fever \[subjective or documented\] and cough or sore throat), and suspected of having influenza.
- Subject (parent, guardian, or authorized legal representative) gives informed consent or assent (child) to the study, and provides signed authorization for use and disclosure of protected health information.
Exclusion
- Any subject classified as "high risk" for exposure to avian or novel influenza, as determined by a Risk-Assessment Questionnaire.
- Subjects who had prior nasal wash/aspirate or nasopharyngeal wash/aspirate specimens collected for routine health-care purposes within the same suspected influenza infection episode.
Key Trial Info
Start Date :
March 1 2010
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
August 1 2010
Estimated Enrollment :
391 Patients enrolled
Trial Details
Trial ID
NCT00863343
Start Date
March 1 2010
End Date
August 1 2010
Last Update
March 1 2012
Active Locations (3)
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1
Naval Health Research Center
San Diego, California, United States, 92106
2
Dartmouth-Hitchcock Medical Center
Lebanon, New Hampshire, United States, 03756
3
John T Mather Hospital
Port Jefferson, New York, United States, 11777