Strep A Fluorescent Immunoassay and Analyzer Field Study

Completed

Conditions studied: Strep Throat

In brief

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.

Key facts

Study ID

NCT01441479

Run by

Quidel Corporation

People needed

1282

Starts

2011-06-01

Expected to finish

2012-12-01

Last updated by the study team

2013-02-07

Who can join

Age: 3 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Best Medical Group — Phoenix, Arizona, United States
• La Costa Pediatrics — Carlsbad, California, United States
• La Jolla Pediatrics — San Diego, California, United States
• Teena Hughes — Tampa, Florida, United States
• FastER Urgent Care — Morris Plains, New Jersey, United States
• Twelve Corners Pediatrics — Rochester, New York, United States
• Advanced Pediatrics — Vienna, Virginia, United States

Full record on ClinicalTrials.gov

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