NCT04618848Unknown不适用
Performance Evaluation Protocol for Sight Diagnostics' OLO CBC Analyzer by Ichilov Oncology Daily Care Center
Sight Diagnostics0 个研究点目标入组 50 人开始时间: 2020年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 50
- 主要终点
- CBC Comparison
研究概览
简要总结
This study aims to establish OLO's performance accuracy of CBC results for finger prick samples across the OLO reportable range, and particularly around relevant medical decision points
详细描述
This study aims to establish OLO's performance accuracy of CBC results for finger prick samples across the OLO reportable range, and particularly around relevant medical decision points.
The evaluation will include two studies:
- A matrix study will compare a capillary sample collected via finger prick with a venous sample collected into a blood tube, both scanned on OLO.
- A method comparison study will compare Sight OLO to the site reference analyzer using a venous sample collected into a blood tube.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Cross Sectional
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Blood samples will be collected from oncologic patients older than 18 years old arriving at the oncologic daily care center of Ichilov hospital, with predefined normal and abnormal blood counts
排除标准
- •Patient younger than 18 years old
- •Visibly hemolyzed specimens (sample plasma should be checked for hemolysis by technician while selection of specimen from tube racks).
- •Visibly clotted specimens (Reasonable to assume that samples processed with clinical reported results are not clotted).
- •A sample that is not successfully scanned on OLO within 3 attempts (e.g. rejected due to irregular cell morphology, or microscopically visible hemolysis).
结局指标
主要结局
CBC Comparison
时间窗: Immediately after sample collection is completed
Comparison between CBC results obtained from the Sight OLO and the reference device in venous and capillary samples covering medical decision points relevant to onclology patient
次要结局
未报告次要终点
研究者
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