Entia Liberty: Analytical Performance Validation - Accuracy and Precision
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Entia Ltd
- 入组人数
- 530
- 试验地点
- 1
- 主要终点
- To obtain the Total Error per parameter from the results of the Entia Liberty device
研究概览
简要总结
This study forms part of Entia's clinical evidence for regulatory submission. This study evaluates Entia Liberty's performance claims with venous blood compared to the gold standard clinical laboratory haematology analysers. Excess blood flagged by the laboratory meeting our requirements will be tested on the Entia Liberty device and have its results compared against the laboratory results. Samples will also be flagged for precision testing (same blood sample, split into 10 Entia Liberty samples).
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
- •Age >18 years old
- •Currently receiving standard of care systemic anti-cancer therapy (chemotherapy, immunotherapy, endocrine and targeted therapy) for solid organ malignancy and has received at least one cycle
- •Blood samples that have been stored in K2-EDTA vacutainers only
- •For Accuracy testing: Samples covering 75% of parameter ranges (Neutrophils: 0.5-7.5 x 109/L, Platelets: 20-450 x 109/L, Haemoglobin: 70-180 g/L), These will be determined by a gold standard analyser which has been recently calibrated.
- •Reliability study: Level range per parameter. These will be determined by a gold standard analyser which has been recently calibrated.
- •Neutrophils (We assume WBC to behave similarly in the same ranges) Low: 0.5-1.2 x 109/L (3 samples), 1.2-2 x 109/L (2 samples) Normal: 2-7 x 109/L (3-4 samples) High: 7-12 x 109/L (1-2 samples)
- •Platelets Low: 50-150 x 109/L (5 samples) Normal: 150-400 x 109/L (3 - 4 samples) High: >400 x 109/L (1-2 samples)
- •Haemoglobin Low: <120 g/L (5 samples) Normal: 120-170 g/L (3 - 4 samples) High: >170 g/L (1-2 samples)
排除标准
- •History of haematological malignancy
结局指标
主要结局
To obtain the Total Error per parameter from the results of the Entia Liberty device
时间窗: 3 months
The dataset from this study will provide evidence to support the device's performance claims.
To obtain the precision per parameter from the results of the Entia Liberty device
时间窗: 3 months
The dataset from this study will provide evidence to support the device's performance claims.
To obtain the bias per parameter from the results of the Entia Liberty device
时间窗: 3 months
The dataset from this study will provide evidence to support the device's performance claims.
To obtain the linearity per parameter from the results of the Entia Liberty device
时间窗: 3 months
The dataset from this study will provide evidence to support the device's performance claims.
次要结局
未报告次要终点