A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients
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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.
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Layout table for eligibility information
Ages Eligible for Study:
Child, Adult, Older Adult
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients presenting with signs and symptoms of pharyngitis for which their doctors ordered a Group A Strep test.
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.
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.