Trials / Completed
CompletedNCT03417869
QuickVue Influenza A + B Test Field Study
- Status
- Completed
- Phase
- —
- Study type
- Observational
- Enrollment
- 1,381 (actual)
- Sponsor
- Quidel Corporation · Industry
- Sex
- All
- Age
- —
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DEVICE | QuickVue Influenza A+B | Rapid diagnostic test with IVD, QuickVue Influenza A+B |
Timeline
- Start date
- 2017-02-16
- Primary completion
- 2018-02-01
- Completion
- 2018-02-01
- First posted
- 2018-01-31
- Last updated
- 2018-03-20
Locations
5 sites across 1 country: United States
Regulatory
- FDA-regulated device study
Source: ClinicalTrials.gov record NCT03417869. Inclusion in this directory is not an endorsement.