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

Quidel

Status: Completed

Conditions: Influenza

Study type: Observational

Funder types: Industry

Identifiers

NCT01309568

CS-0138-01-A

Details and patient eligibility

About

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.

Full 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.

Enrollment: 2,500 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

2,500 participants in 1 patient group

Investigational testing

Description:

Pending the outcome of culture, the subject may be treated with an approved antiviral medication at the doctors discretion.