NCT02068469已完成不适用
Multi-Center Study of an In Vitro Diagnostic Device for the Detection of Strep A
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- IQuum, Inc.
- 入组人数
- 799
- 试验地点
- 5
- 主要终点
- Evaluate sensitivity and specificity of the Liat Strep A assay when compared to culture
研究概览
简要总结
The purpose of this trial is to show the accuracy and specificity of the Liat analyzer and assay for detecting Strep A at the point of care lab compared to culture.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 3 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who are 3 years of age or older
- •Subjects exhibiting symptoms characteristic of pharyngitis, possibly Streptococcus A, including:
- •presence of sore throat, and at least one other symptom from the list below:
- •redness of the posterior pharyngeal wall
- •pharyngeal or tonsillar exudate
- •tonsillar swelling
- •tender cervical lymphadenopathy
- •fever, >38C at presentation or within the past 24 hours
- •Subjects who are able to understand and consent to participation; for minors under the age of 18, this includes parent or legal guardian
排除标准
- •Subjects treated with antibiotics currently or within the previous 7 days.
结局指标
主要结局
Evaluate sensitivity and specificity of the Liat Strep A assay when compared to culture
时间窗: Results based on samples collected at initial visit
次要结局
未报告次要终点
研究者
研究点 (5)
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