QuickVue Influenza A + B Test Field Study (QuickVue Flu)

March 16, 2018 updated by: Quidel Corporation
Demonstrate improved clinical performance of visually read QuickVue Influenza A+B test.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The objective of this study is to demonstrate an improved clinical performance of the visually read QuickVue Influenza A+B test with nasal and nasopharyngeal swab specimens. Clinical performance will be based on comparison of QuickVue results to either cell culture or an FDA-cleared molecular test at one or more Reference Laboratories.

Study Type

Observational

Enrollment (Actual)

1381

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85353
        • Alliance Urgent Care
    • New York
      • Rochester, New York, United States, 14618
        • Twelve Corners Pediatrics
    • Texas
      • Belton, Texas, United States, 76513
        • Veritas, P.A.
      • Dallas, Texas, United States, 75209
        • City Doc Urgent Care
    • Virginia
      • Vienna, Virginia, United States, 22180
        • Advanced Pediatrics

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Subjects will be recruited from the general population as they present to the clinical facility. Subjects must have had a fever within the last two days and exhibiting one or more symptoms characteristic of influenza

Description

Inclusion Criteria:

Subjects will be recruited from the general population as they present to the clinical facility. Subjects must have had a fever within the last two days and exhibiting one or more symptoms characteristic of influenza. They must meet the following criteria to be eligible for enrollment:

  1. Male or Female of all ages (with appropriate consent).
  2. The subject must have had of a fever, ≥ 37.8º C (100º F), within the last two days.

  3. Must also be currently exhibiting one or more of the following symptoms characteristic of influenza-like-illness (ILI).

    1. Nasal congestion
    2. Rhinorrhea
    3. Sore throat
    4. Cough
    5. Headache
    6. Myalgia
    7. Malaise

Exclusion Criteria:

  • 1. Has undergone treatment with anti-influenza antivirals within the previous 7 days, to include 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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Influenza Diagnostic test result
Time Frame: 10 minutes
rapid IVD test
10 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Quidel Corporation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 16, 2017

Primary Completion (ACTUAL)

February 1, 2018

Study Completion (ACTUAL)

February 1, 2018

Study Registration Dates

First Submitted

January 24, 2018

First Submitted That Met QC Criteria

January 24, 2018

First Posted (ACTUAL)

January 31, 2018

Study Record Updates

Last Update Posted (ACTUAL)

March 20, 2018

Last Update Submitted That Met QC Criteria

March 16, 2018

Last Verified

March 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CS-0103-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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