NCT07591740已完成不适用
Comparison Study of the Xpert Hemorrhagic Fever Test Between Trained and Untrained Users on the GeneXpert Edge X System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cepheid
- 入组人数
- 725
- 试验地点
- 1
研究概览
简要总结
A multi-site observation study that was conducted in the United States at 3 CLIA Waived sites with Untrained Users testing on Xpert Hemorrhagic fever tests on Edge X instruments
详细描述
Capillary and Venous whole blood collected from consented healthy individuals contrived with pseudoviral constructs from multiple viruses and non-contrived were tested by untrained users in a CW environment and trained users in a laboratory setting on the Edge X instrument.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 14 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •- Capillary and venous whole blood specimens from individuals asymptomatic for fever
- •Whole blood specimens collected in EDTA specimens collection devices only- Whole Blood specimens collected in EDTA specimen collection devices only
排除标准
- •Participants vaccinated with a Hemorrhagic Fever live virus vaccine within the past 28 days.
- •Participant was previously enrolled into this protocol. • VWB and CWB specimens were not collected according to the manufacturer's instructions.
研究者
研究点 (1)
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