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

Response Biomedical

Status: Completed

Conditions: Influenza

Treatments: Other: Non-invasive diagnostic testing

Study type: Observational

Funder types: Industry

Identifiers

NCT00636662

CSP012

Details and patient eligibility

About

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.

Full 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.

Enrollment: 800 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

800 participants in 1 patient group

all

Description:

any patient exhibiting symptoms of influenza

Treatment:

Other: Non-invasive diagnostic testing