FLU A+B Nasal Swab Clinical Study

Status:	Completed
Conditions:	Influenza
Therapuetic Areas:	Immunology / Infectious Diseases
Healthy:	No
Age Range:	Any
Updated:	3/29/2019
Start Date:	February 2008
End Date:	May 2008

Evaluation of the RAMP FLU A+B Test Versus Viral Culture Using Clinical Nasal Swab Samples From Patients With Suspected Influenza Infections

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.

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.

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.

We found this trial at

sites

Wake Forest University Health Sciences

1 Medical Center Blvd
Winston-Salem, North Carolina 27157

336-716-2011