Strep A Fluorescent Immunoassay and Analyzer Field Study
- Conditions
- Strep Throat
- Registration Number
- NCT01441479
- Lead Sponsor
- Quidel Corporation
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 1282
- 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
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Streptococcus Group B identification Immediate The purpose of this study was to identify via immunofluorescence technology, Group A Streptococcus, which was successfully done.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (7)
La Costa Pediatrics
🇺🇸Carlsbad, California, United States
Best Medical Group
🇺🇸Phoenix, Arizona, 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