FLU A+B Nasal Swab Clinical Study

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

800 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-02-29

Study Completion Date

2008-05-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Influenza

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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all

any patient exhibiting symptoms of influenza

Non-invasive diagnostic testing

Intervention Type OTHER

No patient treatment is altered by enrollment in this trial

Interventions

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Non-invasive diagnostic testing

No patient treatment is altered by enrollment in this trial

Intervention Type OTHER

Eligibility Criteria

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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.

Eligible Sex

ALL

Accepts Healthy Volunteers

No