NCT01494792终止不适用
Sofia Strep A FIA Field Study
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2,090
- 试验地点
- 8
研究概览
简要总结
The purpose of this study is to demonstrate the ability of the Sofia Strep A FIA test and Sofia Analyzer to accurately detect a throat swab specimen for the presence or absence of Group A Streptococcus when compared to culture.
研究设计
- 研究类型
- Observational
- 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
- •Presence of sore throat
- •Redness of the posterior pharyngeal wall
- •Tonsillar exudate
- •Tonsillar swelling
- •Tender anterior cervical adenopathy
- •Fever, > 38º C (100.4ºF) at presentation or within past 24 hours
- •Other symptoms that may be present, in addition to above symptoms for GAS:
- •Rash, typical of scarlet fever
- •Abnormal tympanic membranes
- •Palatal petechiae
排除标准
- •Subjects treated with antibiotics currently or within the previous week (7 days) are not to be included in this study.
- •At clinical sites requiring informed consent, unable to understand and consent to participation; for minors this includes parent or legal guardian.
研究者
研究点 (8)
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