NCT03037957已完成不适用
A Multi-Site Clinical Evaluation of the ARIES Group A Strep Assay in Symptomatic Patients
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 704
- 试验地点
- 5
- 主要终点
- Clinical performance (sensitivity/specificity) for Group A Strep Assay
研究概览
简要总结
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
结局指标
主要结局
Clinical performance (sensitivity/specificity) for Group A Strep Assay
时间窗: Day 1
次要结局
未报告次要终点
研究者
研究点 (5)
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