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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| all | any patient exhibiting symptoms of influenza |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non-invasive diagnostic testing | Other | No patient treatment is altered by enrollment in this trial |
|
| Measure | Description | 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 |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Northwestern University | Chicago | Illinois | United States | |||
| Washington University / St. Louis Children's Hospital |
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| ID | Term |
|---|---|
| D007251 | Influenza, Human |
| ID | Term |
|---|---|
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D009976 | Orthomyxoviridae Infections |
| D012327 | RNA Virus Infections |
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mucous
| St Louis |
| Missouri |
| United States |
| Wake Forest University Health Sciences | Winston-Salem | North Carolina | United States |
| Dell Children's Hospital | Austin | Texas | United States |
| Mt. Sinai Hospital | Toronto | Ontario | Canada |
| D014777 | Virus Diseases |
| D012140 | Respiratory Tract Diseases |