Clinical Evaluation of 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
- Method Comparison for potassium (K) and ionized calcium (iCa) blood tests.
研究概览
简要总结
The objective of this study is to compare the performance of blood tests using the i-STAT 1 System against a comparator blood analysis system.
详细描述
To compare the performance of the i-STAT potassium (K) and ionized calcium (iCa) tests using the i-STAT CG8+ cartridge on the i-STAT 1 analyzer to the performance of K and iCa tests on a comparator blood analysis system 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
Method Comparison for potassium (K) and ionized calcium (iCa) blood tests.
时间窗: Thirty (30) minutes from subject enrollment to the end of the blood draw and testing.
Specimen testing of K and iCa in mmol/L will be performed using the i-STAT CG8+ cartridge on the i-STAT analyzer and a comparator blood analysis system with prospectively collected capillary specimens. Subjects with one valid capillary result on the i-STAT CG8+ cartridge and one valid result on the comparator blood analysis system will be evaluated.
次要结局
未报告次要终点