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

Influenza, Human Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01753531
• Other study ID #: CAP-199
• Status: Completed
• Phase: N/A
• First received: December 17, 2012
• Last updated: June 20, 2013
• Start date: November 2012
• Est. completion date: June 2013

Study information

• Verified date: June 2013
• Source: Sekisui Diagnostics, LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 677
• Est. completion date: June 2013
• Est. primary completion date: April 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 3 Months and older

Eligibility

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 Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Influenza, Human

Intervention

Device:
• Flu Symptoms

Locations

Country	Name	City	State
United States	Pharmacorp Clinical Trials, Inc.	Charleston	South Carolina
United States	Hill Country Medical Associates	New Braunfels	Texas
United States	Ardmore Family Practice	Winston-Salem	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
Sekisui Diagnostics, LLC

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No