NCT01753531

Clinical Performance Study of the Ultra Influenza A&B Test Using Nasal Swabs for Identifying Subjects Who Are Infected With the Influenza Virus Strain Type A or Type B

A Multicenter Performance Evaluation for the Ultra Influenza A&B Test Using Nasal Swabs

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 677 (actual)
• Sponsor: Sekisui Diagnostics, LLC · Industry
• Sex: All
• Age: 3 Months
• Healthy volunteers: Not accepted

Summary

The clinical performance of the Ultra Influenza A\&B 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 A\&B 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 A\&B Test will be performed at Clinical Laboratory Improvement Amendments (CLIA) waived sites by untrained intended users (e.g. 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.

Conditions

• Influenza, Human

Interventions

Type	Name	Description
DEVICE	Flu Symptoms

Timeline

• Start date: 2012-11-01
• Primary completion: 2013-04-01
• Completion: 2013-06-01
• First posted: 2012-12-20
• Last updated: 2013-06-24

Locations

3 sites across 1 country: United States