NCT01667172已完成不适用
Study of Technical Accuracy and Userfriendliness of Two Point-of-care C Reactive Protein Devices
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- KU Leuven
- 入组人数
- 300
- 试验地点
- 6
- 主要终点
- technical accuracy
研究概览
简要总结
Study to test technical accuracy and userfriendliness of two Point-of-care C Reactive Protein devices (POC CRP devices) in comparison with laboratory CRP testing on children and adults.
Research questions:
- Are the POC CRP devices technically accurate? Do the measured values agree with CRP values measured at the clinical laboratory?
- Are the 2 POC CRP devices equivalent ? 2.1. Are the 2 POC CRP devices equally reliable? 2.1.1. Comparison of 2 measurements in the same patient on 1 device (inter-observer-variability) 2.1.2. Comparison of 2 measurements in the same patient on 2 identical devices (inter-device-variability) 2.2. Are the 2 Point-of-Care CRP devices equally userfriendly in a general practice surgery? (userfriendliness
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Participant, Care Provider)
入排标准
- 年龄范围
- 1 Month 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •children: aged 1 month to 14 years
- •adults: aged 18-65 years
排除标准
- •children and adults not understanding Dutch language
结局指标
主要结局
technical accuracy
时间窗: 3 months
correlation obtained between the results from the Point-of-care C Reactive Protein devices and the results from the laboratory
次要结局
- User-friendliness(3 months)
- Inter-device variability(3 months)
- Inter-observer variability(3 months)
研究者
研究点 (6)
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