Status:
COMPLETED
QuickVue Influenza A + B Test Field Study
Lead Sponsor:
Quidel Corporation
Conditions:
Influenza A, Influenza B
Eligibility:
All Genders
Brief Summary
Demonstrate improved clinical performance of visually read QuickVue Influenza A+B test.
Detailed Description
The objective of this study is to demonstrate an improved clinical performance of the visually read QuickVue Influenza A+B test with nasal and nasopharyngeal swab specimens. Clinical performance will ...
Eligibility Criteria
Inclusion
- Subjects will be recruited from the general population as they present to the clinical facility. Subjects must have had a fever within the last two days and exhibiting one or more symptoms characteristic of influenza. They must meet the following criteria to be eligible for enrollment:
- Male or Female of all ages (with appropriate consent).
- The subject must have had of a fever, ≥ 37.8º C (100º F), within the last two days.
- Must also be currently exhibiting one or more of the following symptoms characteristic of influenza-like-illness (ILI).
- Nasal congestion
- Rhinorrhea
- Sore throat
- Cough
- Headache
- Myalgia
- Malaise
Exclusion
- 1\. Has undergone treatment with anti-influenza antivirals within the previous 7 days, to include but not be limited to, Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes.
- 2\. Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.
- 3\. Unable to understand and consent to participation; for minors this includes parent or legal guardian.
Key Trial Info
Start Date :
February 16 2017
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
February 1 2018
Estimated Enrollment :
1381 Patients enrolled
Trial Details
Trial ID
NCT03417869
Start Date
February 16 2017
End Date
February 1 2018
Last Update
March 20 2018
Active Locations (5)
Enter a location and click search to find clinical trials sorted by distance.
1
Alliance Urgent Care
Phoenix, Arizona, United States, 85353
2
Twelve Corners Pediatrics
Rochester, New York, United States, 14618
3
Veritas, P.A.
Belton, Texas, United States, 76513
4
City Doc Urgent Care
Dallas, Texas, United States, 75209