"Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"

Completed

Conditions studied: Influenza

In brief

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.

Key facts

Study ID

NCT01309568

Run by

Quidel Corporation

People needed

2500

Starts

2011-02-01

Expected to finish

2011-04-01

Last updated by the study team

2011-05-12

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

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.

Where it is running

• 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

Full record on ClinicalTrials.gov

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