Clinical Evaluation of i-STAT Analyzer for Glucose, Hematocrit and Sodium
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 297
- 试验地点
- 3
- 主要终点
- Glucose (mg/dL) levels
研究概览
简要总结
The objective of this study is to compare the performance of two i-STAT Analyzers in a Point-of-Care (POC) setting. The evaluation will be performed using a cartridge to test glucose, hematocrit and sodium on capillary specimens.
详细描述
The clinical performance for glucose, hematocrit and sodium assays for capillary samples was evaluated for the investigational i-STAT 500 (Alinity) analyzer based on results of method comparison testing against the i-STAT 1W analyzer.
研究设计
- 研究类型
- Observational
- 观察模型
- Other
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Subject is ≥ 18 years of age
- •Subjects (or their legal representative) who are willing to voluntarily consent to the study
排除标准
- •There are no exclusion criteria
结局指标
主要结局
Glucose (mg/dL) levels
时间窗: Patient's blood is tested within 3 minutes of blood collection
Data analysis
Hematocrit (%PCV) levels
时间窗: Patient's blood is tested within 3 minutes of blood collection
Data analysis
Sodium (mmol/L) levels
时间窗: Patient's blood is tested within 3 minutes of blood collection
Data analysis
次要结局
未报告次要终点