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

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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
Rochester, New York 14618
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Rochester, NY
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Carlsbad, California 92009
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Carlsbad, CA
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Morris Plains, New Jersey 07950
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Morris Plains, NJ
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Phoenix, Arizona 85042
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Phoenix, AZ
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San Diego, California 92121
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San Diego, CA
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Tampa, Florida 33613
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Tampa, FL
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Vienna, Virginia 22180
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Vienna, VA
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