Ignite Creation Date:
2025-12-24 @ 10:47 PM
Ignite Modification Date:
2025-12-25 @ 8:17 PM
Study NCT ID:
NCT03417869
Status:
COMPLETED
Last Update Posted:
2018-03-20
First Post:
2018-01-24
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
QuickVue Influenza A + B Test Field Study
Sponsor:
Quidel Corporation
Organization:
Study Overview
Official Title:
QuickVue Influenza A + B Test Field Study
Status:
COMPLETED
Status Verified Date:
2018-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
QuickVue Flu
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.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: