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

This study has been completed.
Sponsor:
Information provided by:
Quidel Corporation
ClinicalTrials.gov Identifier:
NCT01309568
First received: March 3, 2011
Last updated: May 10, 2011
Last verified: May 2011
  Purpose

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.


Condition
Influenza

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: "Quidel Reader Influenza A + B Test 510(k) and CLIA Waiver Field Study"

Resource links provided by NLM:


Further study details as provided by Quidel Corporation:

Primary Outcome Measures:
  • Diagnosis of infection with influenza [ Time Frame: 15 minutes ] [ Designated as safety issue: No ]
    Accurate diagnosis of infection with influenza A or influenza B confirmed by culture


Biospecimen Retention:   Samples Without DNA

Leftover nasal mucus placed in viral transport media will be retained after culture for possible RT-PCR.


Enrollment: 2500
Study Start Date: February 2011
Study Completion Date: April 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts
Investigational testing
Pending the outcome of culture, the subject may be treated with an approved antiviral medication at the doctors discretion.

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

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

Subjects current exhibiting influenza like illness.

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01309568

Locations
United States, California
La Costa Pediatrics
Carlsbad, California, United States, 92009
Santo Nino Medical Clinic
Panorama City, California, United States, 91402
La Jolla Pediatrics
San Diego, California, United States, 92121
United States, Colorado
Complete Family Care
Northglenn, Colorado, United States, 80234
United States, Florida
Adriana Castro, MD
Miami, Florida, United States, 33173
Teena Hughes, MD
Tampa, Florida, United States, 33613
United States, Illinois
DuPage Family Medicine
Naperville, Illinois, United States, 60564
United States, Kentucky
Paul Janson, MD
Florence, Kentucky, United States, 41042
Paul McLaughlin, MD
Mt. Sterling, Kentucky, United States, 40353
United States, Maryland
Kamakshi Neelkantan, MD
Edgewood, Maryland, United States, 21040
United States, Missouri
Priority Care Pediatrics
Kansas City, Missouri, United States, 64155
United States, New York
Robert Farron, DO
Far Rockaway, New York, United States, 11691
Twelve Corners Pediatrics
Rochester, New York, United States, 14618
United States, Ohio
Montrose Family Practice
Akron, Ohio, United States, 44333
United States, Pennsylvania
Norristown Family Physicians
Norristown, Pennsylvania, United States, 19401
United States, Texas
Dell's Children's Medical Center
Austin, Texas, United States, 78723
Sponsors and Collaborators
Quidel Corporation
Investigators
Study Director: John D Tamerius, PhD Quidel Corporation
  More Information

No publications provided

Responsible Party: John D. Tamerius, PhD, Sr. V.P. Clinical/Regulatory, Quidel Corporation
ClinicalTrials.gov Identifier: NCT01309568     History of Changes
Other Study ID Numbers: CS-0138-01-A
Study First Received: March 3, 2011
Last Updated: May 10, 2011
Health Authority: United States: Food and Drug Administration

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on August 28, 2014