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

Influenza Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01309568
• Other study ID #: CS-0138-01-A
• Status: Completed
• Phase: N/A
• First received: March 3, 2011
• Last updated: May 10, 2011
• Start date: February 2011
• Est. completion date: April 2011

Study information

• Verified date: May 2011
• Source: Quidel Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 2500
• Est. completion date: April 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Influenza
• Influenza, Human

Locations

Country	Name	City	State
United States	Montrose Family Practice	Akron	Ohio
United States	Dell's Children's Medical Center	Austin	Texas
United States	La Costa Pediatrics	Carlsbad	California
United States	Kamakshi Neelkantan, MD	Edgewood	Maryland
United States	Robert Farron, DO	Far Rockaway	New York
United States	Paul Janson, MD	Florence	Kentucky
United States	Priority Care Pediatrics	Kansas City	Missouri
United States	Adriana Castro, MD	Miami	Florida
United States	Paul McLaughlin, MD	Mt. Sterling	Kentucky
United States	DuPage Family Medicine	Naperville	Illinois
United States	Norristown Family Physicians	Norristown	Pennsylvania
United States	Complete Family Care	Northglenn	Colorado
United States	Santo Nino Medical Clinic	Panorama City	California
United States	Twelve Corners Pediatrics	Rochester	New York
United States	La Jolla Pediatrics	San Diego	California
United States	Teena Hughes, MD	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Quidel Corporation

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Diagnosis of infection with influenza	Accurate diagnosis of infection with influenza A or influenza B confirmed by culture	15 minutes	No