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

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ClinicalTrials.gov Identifier: NCT03417869
Recruitment Status : Completed
First Posted : January 31, 2018
Last Update Posted : March 20, 2018
Sponsor:
Information provided by (Responsible Party):
Quidel Corporation

Brief Summary:
Demonstrate improved clinical performance of visually read QuickVue Influenza A+B test.

Condition or disease Intervention/treatment
Influenza A, Influenza B Device: QuickVue Influenza A+B

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
Actual Enrollment : 1381 participants
Observational Model: Other
Time Perspective: Prospective
Official Title: QuickVue Influenza A + B Test Field Study
Actual Study Start Date : February 16, 2017
Actual Primary Completion Date : February 1, 2018
Actual Study Completion Date : February 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot


Intervention Details:
  • Device: QuickVue Influenza A+B
    Rapid diagnostic test with IVD, QuickVue Influenza A+B


Primary Outcome Measures :
  1. Influenza Diagnostic test result [ Time Frame: 10 minutes ]
    rapid IVD test



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Criteria

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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03417869


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

Responsible Party: Quidel Corporation
ClinicalTrials.gov Identifier: NCT03417869     History of Changes
Other Study ID Numbers: CS-0103-02
First Posted: January 31, 2018    Key Record Dates
Last Update Posted: March 20, 2018
Last Verified: March 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No

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