Strep A Fluorescent Immunoassay and Analyzer Field Study

Quidel

Status: Completed

Conditions: Strep Throat

Treatments: Device: In Vitro Diagnostic Device aid in diagnosing

Study type: Observational

Funder types: Industry

Identifiers

NCT01441479

CS-0142-01

Details and patient eligibility

About

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.

Enrollment: 1,282 patients

Sex: All

Ages: 3+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• 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.