FLU A+B Nasal Swab Clinical Study

Response Biomedical Corp.800 enrolled

Overview

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.

Study Type

OBSERVATIONAL

Enrollment

800

Conditions

Influenza

Interventions

Non-invasive diagnostic testingOTHER

No patient treatment is altered by enrollment in this trial

Eligibility

Sex: ALL

Medical Language ↔ Plain English

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.

Locations (5)

Northwestern University

Chicago, Illinois, United States

Washington University / St. Louis Children's Hospital

St Louis, Missouri, United States

Wake Forest University Health Sciences

Winston-Salem, North Carolina, United States

Dell Children's Hospital

Austin, Texas, United States

Outcomes

Primary Outcomes

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.

Time frame: 1 day

Data from ClinicalTrials.gov

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