"Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"
- Conditions
- Influenza
- Registration Number
- NCT01309568
- Lead Sponsor
- Quidel Corporation
- Brief Summary
The objective of this study is to demonstrate the clinical performance of the Quidel Reader Influenza A+B test and Quidel Reader with the following sample types: nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash. Clinical performance will be based on comparison of Quidel Reader Influenza A+B results to cell culture at a Central Reference or Alternative Laboratory.
- Detailed Description
A sufficient number of subjects will be enrolled to achieve a required minimum of cell culture-positive specimens for each sample type, nasal swab, nasopharyngeal swab, and nasopharyngeal aspirate/wash.
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 2500
- Male or Female, of all ages (assuming appropriate consent is obtained).
- Must currently be exhibiting symptoms characteristic of influenza-like-illness (ILI).
For example:
- Fever, ≥ 38º C (100º F), either at the time of the visit or onset within the past two (2) days.
- Nasal congestion
- Rhinorrhea
- Sore throat
- Cough
- Headache
- Myalgia
- Malaise
- Has undergone treatment with anti-influenza antivirals within the previous 7 days, including, for example, one or more of the following, but not be limited to Amantadine, Rimantadine, Ribavirin, Oseltamivir, Zanamivir or any other antiviral currently available in these classes.
- Has been vaccinated by means of an influenza nasal spray/mist vaccine within the previous 7 days.
- Unable to understand and consent to participation; for minors this includes parent or legal guardian.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Diagnosis of infection with influenza 15 minutes Accurate diagnosis of infection with influenza A or influenza B confirmed by culture
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (16)
DuPage Family Medicine
🇺🇸Naperville, Illinois, United States
Robert Farron, DO
🇺🇸Far Rockaway, New York, United States
Twelve Corners Pediatrics
🇺🇸Rochester, New York, United States
La Costa Pediatrics
🇺🇸Carlsbad, California, United States
Paul Janson, MD
🇺🇸Florence, Kentucky, United States
Santo Nino Medical Clinic
🇺🇸Panorama City, California, United States
Complete Family Care
🇺🇸Northglenn, Colorado, United States
Dell's Children's Medical Center
🇺🇸Austin, Texas, United States
Teena Hughes, MD
🇺🇸Tampa, Florida, United States
Priority Care Pediatrics
🇺🇸Kansas City, Missouri, United States
Paul McLaughlin, MD
🇺🇸Mt. Sterling, Kentucky, United States
Kamakshi Neelkantan, MD
🇺🇸Edgewood, Maryland, United States
Norristown Family Physicians
🇺🇸Norristown, Pennsylvania, United States
La Jolla Pediatrics
🇺🇸San Diego, California, United States
Adriana Castro, MD
🇺🇸Miami, Florida, United States
Montrose Family Practice
🇺🇸Akron, Ohio, United States