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FLU A+B Nasal Swab Clinical Study (FLUA+B)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00636662
Recruitment Status : Completed
First Posted : March 14, 2008
Last Update Posted : January 12, 2009
Information provided by:
Response Biomedical Corp.

Brief Summary:
The purpose of this clinical study is to obtain clearance for the nasal swab sample type by demonstrating the performance characteristics of the FLU A+B Test versus standard laboratory culture for Influenza A and B viruses using nasal swab samples.

Condition or disease Intervention/treatment
Influenza Other: Non-invasive diagnostic testing

Detailed Description:

Patients exhibiting symptoms of influenza enrolled in a fashion that confidentiality of all personal health information is maintained.

No patient treatment is affected by enrollment in this trial.

Study Type : Observational
Actual Enrollment : 800 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of the RAMP FLU A+B Test Versus Viral Culture Using Clinical Nasal Swab Samples From Patients With Suspected Influenza Infections
Study Start Date : February 2008
Primary Completion Date : May 2008
Study Completion Date : May 2008

Resource links provided by the National Library of Medicine

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

Group/Cohort Intervention/treatment
any patient exhibiting symptoms of influenza
Other: Non-invasive diagnostic testing
No patient treatment is altered by enrollment in this trial

Primary Outcome Measures :
  1. Support the addition of nasal swab sample type to labeling for the FLU A+B Test. The nasal swab sample data will be analyzed for the FLU A+B Test versus standard laboratory culture identification to determine the sensitivity and specificity. [ Time Frame: 1 day ]

Biospecimen Retention:   Samples With DNA

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Nasal swab samples will be collected from subjects suspected of having influenza infections and onset has occurred within 3 days of examination. Across the sites these samples will be drawn from an approximately 60% pediatric patients (<21 years), and 40% adult patients (>21 years) and it is expected that the population will be divided approximately equally between males and females.

Inclusion Criteria:

  • Male and Female of all age groups
  • Patients exhibiting influenza symptoms (i.e., fever, body aches, headaches, cough, sore throat, and other respiratory symptoms) at the time of examination
  • Patients must either present with a fever (>100ºF; >37.8ºC) at time of examination or have had a fever (>100ºF; >37.8ºC) or declare at time of the examination that they had a fever within the previous 3 days prior to the examination
  • Must be able to collect sample using the nasal swab sample type

Exclusion Criteria:

  • Patients with no fever at time of examination or within the 3 days prior to examination and/or are currently undergoing treatment (including anti-virals) will be excluded from the 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 identifier (NCT number): NCT00636662

United States, Illinois
Northwestern University
Chicago, Illinois, United States
United States, Missouri
Washington University / St. Louis Children's Hospital
St. Louis, Missouri, United States
United States, North Carolina
Wake Forest University Health Sciences
Winston-Salem, North Carolina, United States
United States, Texas
Dell Children's Hospital
Austin, Texas, United States
Canada, Ontario
Mt. Sinai Hospital
Toronto, Ontario, Canada
Sponsors and Collaborators
Response Biomedical Corp.

Responsible Party: Bryon Grove - Clinical Support Associate, Response Biomedical Identifier: NCT00636662     History of Changes
Other Study ID Numbers: CSP012
First Posted: March 14, 2008    Key Record Dates
Last Update Posted: January 12, 2009
Last Verified: January 2009

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