NCT07287631招募中不适用
Clinical Evaluation of Precision for the Potassium and Ionized Calcium Tests Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer for Capillary Specimens
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 425
- 试验地点
- 4
- 主要终点
- Precision assessment
研究概览
简要总结
Assess precision of the i-STAT potassium (K) and ionized calcium (iCa) tests using i-STAT CG8+ cartridge on the i-STAT 1 analyzer.
详细描述
The objective of this study is to assess the precision of the i-STAT K and iCa tests using the IUO i-STAT CG8+ cartridge on the i-STAT 1 analyzer using results from two separate capillary specimens from each subject enrolled in the study.
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
- None
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
- •Signed and dated consent form (waiver/alteration of consent, waiver of documentation of consent may be acceptable, per IRB)
- •≥ 18 years of age
排除标准
- •1. Previous enrollment in this study
结局指标
主要结局
Precision assessment
时间窗: Thirty (30) minutes from subject enrollment to the end of the blood draw and testing.
Assess the precision of the i-STAT potassium (K) and ionized calcium (iCa) tests in mmol/L with the investigational use only (IUO) i-STAT CG8+ cartridge on the i-STAT 1 analyzer using results from capillary specimens from each subject enrolled in the study.
次要结局
未报告次要终点
研究者
研究点 (4)
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