QuickVue Influenza A + B Test Field Study

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03417869

Acronym

QuickVue Flu

Enrollment

1381

Registered

2018-01-31

Start date

2017-02-16

Completion date

2018-02-01

Last updated

2018-03-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Influenza A, Influenza B

Brief summary

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

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.

Interventions

DEVICEQuickVue Influenza A+B

Rapid diagnostic test with IVD, QuickVue Influenza A+B

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
Influenza Diagnostic test result	10 minutes	rapid IVD test

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026