Sofia Strep A FIA Field Study
| Status: | Completed |
|---|---|
| Conditions: | Infectious Disease |
| Therapuetic Areas: | Immunology / Infectious Diseases |
| Healthy: | No |
| Age Range: | Any |
| Updated: | 9/23/2012 |
| Start Date: | November 2011 |
| End Date: | March 2012 |
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.
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
We found this trial at
8
sites
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225 E Chicago Ave
Chicago, Illinois 60611
Chicago, Illinois 60611
(312) 227-4000
Ann & Robert H. Lurie Children's Hospital of Chicago Ann & Robert H. Lurie Children
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