Clinical trial 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
Official title: A Multicenter Performance Evaluation for the Ultra Influenza A&B Test Using Nasal Swabs
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Influenza, Human
Keywords: Ultra Influenza A and B
Influenza Type A
Influenza Type B
Flu
Sekisui Diagnostics
Lead sponsor: Sekisui Diagnostics, LLC
Sponsor class: INDUSTRY
First posted: 2012-12-20
Enrollment: 677
Sex: ALL
Minimum age (years): 3
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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)

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.


Eligibility 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.

Primary outcomes:
measure: Identify subjects who are infected with the virus strain type A or type B
timeFrame: 6 months
Secondary outcomes:
measure: Demonstrate the ability of untrained intended users to effectively run and read the Ultra Influenza A&B Test with insignificant risk of erroneous results.
timeFrame: 6 months
Other outcomes:
Locations:
city: Winston-Salem
country: United States
facility: Ardmore Family Practice
state: North Carolina
city: Charleston
country: United States
facility: Pharmacorp Clinical Trials, Inc.
state: South Carolina
city: New Braunfels
country: United States
facility: Hill Country Medical Associates
state: Texas
Study officials:
affiliation: Ardmore Family Practice
name: Robert D Rosen, MD
role: PRINCIPAL_INVESTIGATOR
References: