Sofia Strep A FIA Field Study

Quidel

Status: Terminated

Conditions: Strep Throat; Group A Streptococcus

Treatments: Device: In Vitro Diagnositc aid for diagnosis

Study type: Observational

Funder types: Industry

Identifiers

NCT01494792

CS-0142-02

Details and patient eligibility

About

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.

Enrollment: 2,090 patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

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.