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

Completed

• 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.

Study Timeline

• Study Start: 2011-02
• Study First Submitted: 2011-03-03
• Study First Submitted QC: 2011-03-03
• Study First Posted: 2011-03-07
• Primary Completion: 2011-04
• Study Completion: 2011-04
• Status Verified: 2011-05
• Last Update Submitted: 2011-05-10
• Last Update Posted: 2011-05-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 2500

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

• 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

Trial Locations

Locations (16)

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; 🇺🇸 Mt. Sterling, Kentucky, United States

Kamakshi Neelkantan, MD; 🇺🇸 Edgewood, Maryland, United States

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