Influenza
Conditions
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.
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.
Interventions
No patient treatment is altered by enrollment in this trial
Sponsors
Response Biomedical Corp.
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | 1 day |
Countries
Canada, United States
Outcome results
None listed