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

sites

Ann & Robert H. Lurie Children's Hospital of Chicago

225 E Chicago Ave
Chicago, Illinois 60611

(312) 227-4000