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

Sponsor

Sekisui Diagnostics, LLC (Industry)

Overall Status

Completed

CT.gov ID

NCT01753531

Collaborator

(none)

677

Enrollment

Locations

Duration (Months)

225.7

Patients Per Site

32.4

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Influenza, Human	Device: Flu Symptoms

Study Design

Study Type:

Observational

Actual Enrollment :

677 participants

Observational Model:

Cohort

Time Perspective:

Prospective

Official Title:

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

Study Start Date :

Nov 1, 2012

Actual Primary Completion Date :

Apr 1, 2013

Actual Study Completion Date :

Jun 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Flu Symptoms	Device: Flu Symptoms

Arm

Intervention/Treatment

Flu Symptoms

Device: Flu Symptoms

Outcome Measures

Primary Outcome Measures

Identify subjects who are infected with the virus strain type A or type B [6 months]
Characterize the performance of the Ultra Influenza A&B Test and to identify subjects who are infected with the influenza virus strain type A or type B. Performance data generated will support a 510k submission to FDA for clearance of the assay.

Secondary Outcome Measures

Demonstrate the ability of untrained intended users to effectively run and read the Ultra Influenza A&B Test with insignificant risk of erroneous results. [6 months]
Demonstrate the ability of untrained intended users to effectively run and read the Ultra Influenza A&B Test with insignificant risk of erroneous results. Qualitative results obtained using the Ultra Influenza A&B Test will be compared to viral culture with direct fluorescent antibody (DFA) confirmation testing on specimens collected during this study. Data demonstrating ease of use will support a request to FDA for CLIA waived categorization of the assay.

Eligibility Criteria

Criteria

Ages Eligible for Study:

3 Months and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

The subject may be of any age and either gender.
Preliminary assessment of the subject by the Investigator/designee should be suggestive of influenza virus infection. Subject should present with an influenza-like febrile respiratory illness defined as (1) presentation within the last 48 hours of developing a subjective feeling of being feverish and/or a temperature recorded at the clinic within the last 48 hours of greater than or equal to 100.5 F and (2) at least two of the following symptoms: cough, nasal congestion, rhinorrhea, sore throat, headache, myalgia.
Written informed consent must be obtained prior to study enrollment.

A subject who is 18 years or older must be willing to give written informed consent and must agree to comply with study procedures.
The legal authorized representative of a subject who is under the age of 18 must give written informed consent and agree to comply with study procedures. Active written assent should be obtained from children of appropriate intellectual age (as defined by the IRB).

Exclusion Criteria:

The subject underwent a nasal wash/aspirate as part of standard-of-care testing during this study visit.
The subject is undergoing treatment currently and/or within the past 7 days of the study visit with a nasally administered influenza vaccine (FluMist) or with anti-viral medication, which may include but is not limited to Amantadine (Symmetrel), Rimantadine (Flumadine), Zanamivir (Relenza), Oseltamivir (Tamiflu) or Ribavirin.
The subject is currently receiving or has received within the past thirty (30) days of the study visit an experimental biologic, drug or device, including either treatment or therapy.
The subject has previously participated in this research study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Ardmore Family Practice	Winston-Salem	North Carolina	United States	27103
2	Pharmacorp Clinical Trials, Inc.	Charleston	South Carolina	United States	29412
3	Hill Country Medical Associates	New Braunfels	Texas	United States	78130