Performance of Ellume·Lab Group A Strep Test Versus Culture for the Rapid Detection of Group A Streptococcus in Patients With Acute Pharyngitis.

Inclusion criteria

• Male and female participants aged 3 years of age or older
• Must currently be presenting with symptoms characteristic of pharyngitis, possibly Group A Strep, including:

• Acute onset of sore throat;
• Fever ≥ 37.8° C (100° F) at presentation or history or parent/guardian-reported history of fever ≥ 37.8° C or feeling feverish within 24 hours of presentation and;
• At least one of the following:

• Red and swollen/inflamed tonsils;
• Pharyngeal or tonsillar exudate; o Cervical lymphadenopathy
• ≤ 5 days from onset of signs and symptoms of pharyngitis
• Parent/legal guardian of Participants < 18 years of age capable and willing to give informed consent
• Participants ≥18 years of age capable and willing to give informed consent

Exclusion criteria

• Participants < 3 years of age
• Participants undergoing treatment with antibiotics, or those who have undergone treatment with antibiotics for current episode of pharyngitis
• Participants who have pharyngitis with clinical features that suggest a viral etiology such as, cough, runny nose, upper respiratory symptoms, and/or oral ulcers
• Currently enrolled in another clinical trial or used any investigational device within 30 days preceding informed consent
• Participants 18 years of age or older unable to understand English and consent to participation
• Parent/legal guardian of Participants < 18 years of age unable to understand English and consent to participation of child