Pharyngitis Bacterial
Conditions
Brief summary
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.
Interventions
DEVICEARIES Group A Strep Assay
Sponsors
Luminex Corporation
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinical performance (sensitivity/specificity) for Group A Strep Assay | Day 1 |
Countries
United States
Outcome results
None listed