"Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"
1 other identifier
observational
2,500
1 country
16
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Feb 2011
Shorter than P25 for all trials
16 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2011
CompletedFirst Submitted
Initial submission to the registry
March 3, 2011
CompletedFirst Posted
Study publicly available on registry
March 7, 2011
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2011
CompletedMay 12, 2011
May 1, 2011
2 months
March 3, 2011
May 10, 2011
Conditions
Outcome Measures
Primary Outcomes (1)
Diagnosis of infection with influenza
Accurate diagnosis of infection with influenza A or influenza B confirmed by culture
15 minutes
Study Arms (1)
Investigational testing
Pending the outcome of culture, the subject may be treated with an approved antiviral medication at the doctors discretion.
Eligibility Criteria
Subjects current exhibiting influenza like illness.
You may qualify if:
- 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
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (16)
La Costa Pediatrics
Carlsbad, California, 92009, United States
Santo Nino Medical Clinic
Panorama City, California, 91402, United States
La Jolla Pediatrics
San Diego, California, 92121, United States
Complete Family Care
Northglenn, Colorado, 80234, United States
Adriana Castro, MD
Miami, Florida, 33173, United States
Teena Hughes, MD
Tampa, Florida, 33613, United States
DuPage Family Medicine
Naperville, Illinois, 60564, United States
Paul Janson, MD
Florence, Kentucky, 41042, United States
Paul McLaughlin, MD
Mount Sterling, Kentucky, 40353, United States
Kamakshi Neelkantan, MD
Edgewood, Maryland, 21040, United States
Priority Care Pediatrics
Kansas City, Missouri, 64155, United States
Robert Farron, DO
Far Rockaway, New York, 11691, United States
Twelve Corners Pediatrics
Rochester, New York, 14618, United States
Montrose Family Practice
Akron, Ohio, 44333, United States
Norristown Family Physicians
Norristown, Pennsylvania, 19401, United States
Dell's Children's Medical Center
Austin, Texas, 78723, United States
Biospecimen
Leftover nasal mucus placed in viral transport media will be retained after culture for possible RT-PCR.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
John D Tamerius, PhD
Quidel Corporation
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
Study Record Dates
First Submitted
March 3, 2011
First Posted
March 7, 2011
Study Start
February 1, 2011
Primary Completion
April 1, 2011
Study Completion
April 1, 2011
Last Updated
May 12, 2011
Record last verified: 2011-05