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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

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ClinicalTrials.gov Identifier: NCT01753531
Recruitment Status : Completed
First Posted : December 20, 2012
Last Update Posted : June 24, 2013
Sponsor:
Information provided by (Responsible Party):
Sekisui Diagnostics, LLC

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
Influenza, Human Device: Flu Symptoms

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 : November 2012
Actual Primary Completion Date : April 2013
Actual Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Flu Flu Shot
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Identify subjects who are infected with the virus strain type A or type B [ Time Frame: 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 :
  1. Demonstrate the ability of untrained intended users to effectively run and read the Ultra Influenza A&B Test with insignificant risk of erroneous results. [ Time Frame: 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.


Biospecimen Retention:   Samples With DNA
Nasal swab specimens


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Ages Eligible for Study:   3 Months and older   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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)
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01753531


Locations
United States, North Carolina
Ardmore Family Practice
Winston-Salem, North Carolina, United States, 27103
United States, South Carolina
Pharmacorp Clinical Trials, Inc.
Charleston, South Carolina, United States, 29412
United States, Texas
Hill Country Medical Associates
New Braunfels, Texas, United States, 78130
Sponsors and Collaborators
Sekisui Diagnostics, LLC
Investigators
Principal Investigator: Robert D Rosen, MD Ardmore Family Practice

Responsible Party: Sekisui Diagnostics, LLC
ClinicalTrials.gov Identifier: NCT01753531     History of Changes
Other Study ID Numbers: CAP-199
First Posted: December 20, 2012    Key Record Dates
Last Update Posted: June 24, 2013
Last Verified: June 2013

Keywords provided by Sekisui Diagnostics, LLC:
Ultra Influenza A and B
Influenza Type A
Influenza Type B
Flu
Sekisui Diagnostics

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases