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

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.

Study Overview

• Status: Completed
• Conditions: Influenza, Human
• Intervention / Treatment: Device: Flu Symptoms

• Study Type: Observational
• Enrollment (Actual): 677

Contacts and Locations

Study Locations

• United States
  • North Carolina
    • Winston-Salem, North Carolina, United States, 27103
      • Ardmore Family Practice
  • South Carolina
    • Charleston, South Carolina, United States, 29412
      • Pharmacorp Clinical Trials, Inc.
  • Texas
    • New Braunfels, Texas, United States, 78130
      • Hill Country Medical Associates

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 3 months and older (ADULT, OLDER_ADULT, CHILD)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Subjects presenting with symptoms suggestive of influenza virus infection will be enrolled from geographically diverse CLIA Waived Intended Users (Physicians office laboratories, clinics or equivalents)

Description

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.

  1. A subject who is 18 years or older must be willing to give written informed consent and must agree to comply with study procedures.
  2. 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.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Flu Symptoms	Device: Flu Symptoms

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Identify subjects who are infected with the virus strain type A or type B	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.	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Demonstrate the ability of untrained intended users to effectively run and read the Ultra Influenza A&B Test with insignificant risk of erroneous results.	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.	6 months

Collaborators and Investigators

• Sponsor: Sekisui Diagnostics, LLC
• Investigators: Principal Investigator: Robert D Rosen, MD, Ardmore Family Practice

Study record dates

Study Major Dates

• Study Start: November 1, 2012
• Primary Completion (ACTUAL): April 1, 2013
• Study Completion (ACTUAL): June 1, 2013

Study Registration Dates

• First Submitted: December 17, 2012
• First Submitted That Met QC Criteria: December 19, 2012
• First Posted (ESTIMATE): December 20, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): June 24, 2013
• Last Update Submitted That Met QC Criteria: June 20, 2013
• Last Verified: June 1, 2013

More Information

Terms related to this study

• Keywords: Flu; Influenza Type B; Ultra Influenza A and B; Influenza Type A; Sekisui Diagnostics
• Additional Relevant MeSH Terms: RNA Virus Infections; Virus Diseases; Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Orthomyxoviridae Infections; Influenza, Human
• Other Study ID Numbers: CAP-199