NCT07370454已完成不适用
Clinical Evaluation of the Xpert Hemorrhagic Fever Test Using Clinical Specimens and Contrived Samples on the GeneXpert Edge X System
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Cepheid
- 入组人数
- 408
- 试验地点
- 1
- 主要终点
- Clinical performance comparing Xpert Hemorrhagic Fever to known status of specimens
研究概览
简要总结
A multi-site observation study that was conducted a geographically diverse sites across the United States
详细描述
Capillary and venous whole blood specimens were prospectively collected from consented individuals symptomatic or asymptomatic of fever
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
- 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 blood donors who symptomatic for fever lasting ≤ 10 days OR asymptomatic for fever
- •Whole blood specimens collected in EDTA specimens collection devices only
排除标准
- •Any whole blood specimens from blood donors vaccinated with a Hemorrhagic Fever live virus vaccine within the past 28 days
- •Any whole blood specimen that were previously enrolled
- •Any whole blood specimens not collected according to the manufacturer's instructions
研究组 & 干预措施
Capillary and venous whole blood specimens
whole blood specimens from individuals asymptomatic or symptomatic of fever
干预措施: Xpert Hemorrhagic Fever test (Diagnostic Test)
结局指标
主要结局
Clinical performance comparing Xpert Hemorrhagic Fever to known status of specimens
时间窗: Clinical Performance assessed in specimens collected at Baseline
Xpert test compared to expected status
次要结局
未报告次要终点
研究者
研究点 (1)
Loading locations...
相似试验
尚未招募
不适用
Application of Quantitative Hemorrhage Detection in Fetomaternal Hemorrhage Syndrome for the Diagnosis of Hemolytic Disease of the NewbornNCT07371520Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine100
招募中
4 期
Avoiding Risks of Thrombosis and bleeding in Surgery (ARTS) trial2023-508147-43-00HUS Helsinki University Hospital1,000
招募中
不适用
Lipopolysaccharide Adsorption (Efferon LPS) in Patients With Thermal BurnsNCT07259668Efferon JSC15
已完成
不适用
Exploratory Clinical Study and Validation of Blood Biomarkers for Alzheimer's DiseaseDementiaNCT07294586Amoneta Diagnostics SAS200
招募中
3 期
Safety and efficacy of apixaban versus warfarin in peritoneal dialysis patients with non valvular atrial fibrillation: a randomized controlled trial2023-507544-37-00Centre Hospitalier Universitaire De Caen Normandie178