Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 6:31 PM
Ignite Modification Date:
2025-12-24 @ 6:31 PM
NCT ID:
NCT03037957
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Study:
NCT03037957
Study Brief:
Protocol Section:
NCT03037957