Sofia Strep A FIA Field Study
- Conditions
- Group A StreptococcusStrep Throat
- Registration Number
- NCT01494792
- Lead Sponsor
- Quidel Corporation
- Brief Summary
The purpose of this study is to demonstrate the ability of the Sofia Strep A FIA test and Sofia Analyzer to accurately detect a throat swab specimen for the presence or absence of Group A Streptococcus when compared to culture.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 2090
- Presence of sore throat
- Redness of the posterior pharyngeal wall
- Tonsillar exudate
- Tonsillar swelling
- Tender anterior cervical adenopathy
- Fever, > 38º C (100.4ºF) at presentation or within past 24 hours
Other symptoms that may be present, in addition to above symptoms for GAS:
- Rash, typical of scarlet fever
- Abnormal tympanic membranes
- Palatal petechiae
- Subjects treated with antibiotics currently or within the previous week (7 days) 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
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (8)
Montrose Family Practice
🇺🇸Akron, Ohio, United States
La Jolla Pediatrics
🇺🇸San Diego, California, United States
Advanced Pediatrics
🇺🇸Vienna, Virginia, United States
Children's Memorial Hospital
🇺🇸Chicago, Illinois, United States
Santo Nino Medical Clinic
🇺🇸Panorama City, California, United States
La Costa Pediatrics
🇺🇸Carlsbad, California, United States
Teena Hughes, MD
🇺🇸Tampa, Florida, United States
Twelve Corners Pediatrics
🇺🇸Rochester, New York, United States