Strep A Fluorescent Immunoassay and Analyzer Field Study
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 2/4/2013 |
| Start Date: | June 2011 |
| End Date: | November 2012 |
The purpose of this study is to demonstrate the ability of the Strep A Fluorescent
Immunoassay Analyzer to accurately detect a throat swab specimen for the presence or absence
of Strep A when compared to culture.
Inclusion Criteria:
- Male and female subjects three (3) years of age or older
Must currently be exhibiting one or more of the following symptoms characteristic of
pharyngitis
- Extreme sore throat
- Redness of the posterior pharyngeal wall
- Difficulty Swallowing
- Fever, >38.7C (100F) at presentation or within past 24 hours
- Pharyngeal exudate
- Tender cervical lymphadenopathy
- Absence of cough or other upper respiratory symptoms
Exclusion Criteria:
- Subjects currently under treatment with antibiotics are not to be included in this
study.
- At clinical sites requiring informed consent, unable to understand and consent to
participation; for minors this includes parent or legal guardian.
We found this trial at
7
sites
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