A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients

A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients

A multi-center evaluation to assess the diagnostic sensitivity and specificity of the ARIES Group A Strep Assay will be established through a method comparison using prospectively collected, de-identified, clinical samples collected during the enrollment period.

Inclusion Criteria:

• Patient and/or patient's legal guardian is willing and able to give informed consent and/or assent for extra research sample.
• The subject's specimen is a throat swab in Liquid Amies based transport medium.
• The specimen is from an adult or pediatric, male or female subject who is either hospitalized, admitted to a hospital emergency department, visiting an outpatient clinical or resident of a long term care facility.
• The specimen is from a patient for whom a requisition has been made for Group A Strep testing
• The specimen is from a patient exhibiting clinical signs and symptoms of pharyngitis consistent with Group A Strep infection.
• The specimen was received in good condition (no leakage or drying of the specimen).
• The specimen volume is ≥ 850 µL.

Exclusion Criteria:

• The specimen is from a patient who did not provide informed consent/assent.
• The specimen is not a throat swab collected in Liquid Amies based transport medium.
• The specimen is from a patient who is undergoing antibiotic treatment.
• The specimen was not properly collected, transported, processed or stored according to the instructions provided by the Sponsor in Section 9 below.
• The specimen volume is < 850 µL.