In Vitro Diagnostic Device for the Detection of Strep A

Inclusion Criteria: * Subjects who are 3 years of age or older * Subjects exhibiting symptoms characteristic of pharyngitis, possibly Streptococcus A, including: * presence of sore throat, and at least one other symptom from the list below: * redness of the posterior pharyngeal wall * pharyngeal or tonsillar exudate * tonsillar swelling * tender cervical lymphadenopathy * fever, \>38C at presentation or within the past 24 hours * Subjects who are able to understand and consent to participation; for minors under the age of 18, this includes parent or legal guardian Exclusion Criteria: * Subjects treated with antibiotics currently or within the previous 7 days.