Ignite Creation Date:
2024-05-06 @ 1:13 AM
Last Modification Date:
2024-10-26 @ 11:00 AM
Study NCT ID:
NCT01753531
Status:
COMPLETED
Last Update Posted:
2013-06-24
First Post:
2012-12-17
Brief Title:
Clinical Performance Study of the Ultra Influenza AB Test Using Nasal Swabs for Identifying Subjects Who Are Infected With the Influenza Virus Strain Type A or Type B
Sponsor:
Sekisui Diagnostics LLC
Organization:
Sekisui Diagnostics LLC
Study Overview
Official Title:
A Multicenter Performance Evaluation for the Ultra Influenza AB Test Using Nasal Swabs
Status:
COMPLETED
Status Verified Date:
2013-06
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:
None
Brief Summary:
The clinical performance of the Ultra Influenza AB Test will be demonstrated during a clinical trial in which prospectively collected nasal swabs are used in identifying subjects who are infected with the influenza virus strain type A or type B The Ultra Influenza AB Test qualitative results will be compared to Gold Standard viral culture with Direct Fluorescent Antibody DFA confirmation techniques using nasal swabs collected from symptomatic subjects The Ultra Influenza AB Test will be performed at Clinical Laboratory Improvement Amendments CLIA waived sites by untrained intended users eg nurses physician assistants medical assistants etc For viral culture testing with DFA confirmation testing nasal swab specimen testing will be performed by a designated reference laboratory
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None