QuickVue Influenza A + B Test Field Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1381 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-02-16

Study Completion Date

2018-02-01

Brief Summary

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

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Detailed Description

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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.

Conditions

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Influenza A, Influenza B

Study Design

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Observational Model Type

OTHER

Study Time Perspective

PROSPECTIVE

Interventions

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QuickVue Influenza A+B

Rapid diagnostic test with IVD, QuickVue Influenza A+B

Intervention Type DEVICE

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No