Strep A Fluorescent Immunoassay and Analyzer Field Study
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government.
Read our disclaimer for details.
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.
Condition or disease
Device: In Vitro Diagnostic Device aid in diagnosing
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study:
3 Years and older (Child, Adult, Senior)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Subjects must be greater than 3 years of age and exhibiting symptoms characteristic of pharyngitis, possibly Group A Streptococcus.
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
Fever, >38.7C (100F) at presentation or within past 24 hours
Tender cervical lymphadenopathy
Absence of cough or other upper respiratory symptoms
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.