Clinical trial NCT01309568: "Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"
Official title: "Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza
Lead sponsor: Quidel Corporation
Sponsor class: INDUSTRY
First posted: 2011-03-07
Enrollment: 2500
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects current exhibiting influenza like illness.

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.

Eligibility criteria: Inclusion Criteria:

1. Male or Female, of all ages (assuming appropriate consent is obtained).
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:

1. 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.
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.

Primary outcomes:
measure: Diagnosis of infection with influenza
timeFrame: 15 minutes
Secondary outcomes:
Other outcomes:
Locations:
city: Carlsbad
country: United States
facility: La Costa Pediatrics
state: California
city: Panorama City
country: United States
facility: Santo Nino Medical Clinic
state: California
city: San Diego
country: United States
facility: La Jolla Pediatrics
state: California
city: Northglenn
country: United States
facility: Complete Family Care
state: Colorado
city: Miami
country: United States
facility: Adriana Castro, MD
state: Florida
city: Tampa
country: United States
facility: Teena Hughes, MD
state: Florida
city: Naperville
country: United States
facility: DuPage Family Medicine
state: Illinois
city: Florence
country: United States
facility: Paul Janson, MD
state: Kentucky
city: Mt. Sterling
country: United States
facility: Paul McLaughlin, MD
state: Kentucky
city: Edgewood
country: United States
facility: Kamakshi Neelkantan, MD
state: Maryland
city: Kansas City
country: United States
facility: Priority Care Pediatrics
state: Missouri
city: Far Rockaway
country: United States
facility: Robert Farron, DO
state: New York
city: Rochester
country: United States
facility: Twelve Corners Pediatrics
state: New York
city: Akron
country: United States
facility: Montrose Family Practice
state: Ohio
city: Norristown
country: United States
facility: Norristown Family Physicians
state: Pennsylvania
city: Austin
country: United States
facility: Dell's Children's Medical Center
state: Texas
Study officials:
affiliation: Quidel Corporation
name: John D Tamerius, PhD
role: STUDY_DIRECTOR
References: