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

Luminex

Status: Completed

Conditions: Pharyngitis Bacterial

Treatments: Device: ARIES Group A Strep Assay

Study type: Observational

Funder types: Industry

Identifiers

NCT03037957

LMA-GAS-01-CS-006

Details and patient eligibility

About

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.

Enrollment: 704 patients

Sex: All

Volunteers: No Healthy Volunteers

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.

Trial design

704 participants in 1 patient group

Group A Strep Assay

Treatment:

Device: ARIES Group A Strep Assay