"Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"
NCT ID: NCT01309568
Last Updated: 2011-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
2500 participants
OBSERVATIONAL
2011-02-28
2011-04-30
Brief Summary
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Detailed Description
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* The 510(k) study will include combined results from all sites and require the following for all three sample types: a minimum of 50 fresh positive results for influenza A, and 30 fresh positive results for influenza B.
* The CLIA Waiver submission will include combined results from all sites for a total of 120 positive specimens for both influenza A and influenza B. The nasal swab will be the primary sample type planned for the CLIA Waiver submission. However, depending upon the prevalence of influenza, nasopharyngeal swab and/or nasopharyngeal aspirate/wash may also be submitted for CLIA Waiver.
Conditions
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Study Design
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CASE_ONLY
PROSPECTIVE
Study Groups
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Investigational testing
Pending the outcome of culture, the subject may be treated with an approved antiviral medication at the doctors discretion.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
2. Must currently be exhibiting symptoms characteristic of influenza-like-illness (ILI).
For example:
1. Fever, ≥ 38º C (100º F), either at the time of the visit or onset within the past two (2) days.
2. Nasal congestion
3. Rhinorrhea
4. Sore throat
5. Cough
6. Headache
7. Myalgia
8. Malaise
Exclusion Criteria
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.
ALL
No
Sponsors
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Quidel Corporation
INDUSTRY
Responsible Party
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Quidel Corporation
Principal Investigators
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John D Tamerius, PhD
Role: STUDY_DIRECTOR
Quidel Corporation
Locations
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La Costa Pediatrics
Carlsbad, California, United States
Santo Nino Medical Clinic
Panorama City, California, United States
La Jolla Pediatrics
San Diego, California, United States
Complete Family Care
Northglenn, Colorado, United States
Adriana Castro, MD
Miami, Florida, United States
Teena Hughes, MD
Tampa, Florida, United States
DuPage Family Medicine
Naperville, Illinois, United States
Paul Janson, MD
Florence, Kentucky, United States
Paul McLaughlin, MD
Mount Sterling, Kentucky, United States
Kamakshi Neelkantan, MD
Edgewood, Maryland, United States
Priority Care Pediatrics
Kansas City, Missouri, United States
Robert Farron, DO
Far Rockaway, New York, United States
Twelve Corners Pediatrics
Rochester, New York, United States
Montrose Family Practice
Akron, Ohio, United States
Norristown Family Physicians
Norristown, Pennsylvania, United States
Dell's Children's Medical Center
Austin, Texas, United States
Countries
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Other Identifiers
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CS-0138-01-A
Identifier Type: -
Identifier Source: org_study_id
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