NCT06291493已完成不适用
Clinical Evaluation of Precision for the Potassium (K) Test in Capillary Specimens Using the i-STAT CG8+ Cartridge With the i-STAT 1 Analyzer
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 161
- 试验地点
- 4
- 主要终点
- Precision for Potassium (K) Test
研究概览
简要总结
Assessing precision of i-STAT K test using the IUO 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 test using the IUO i-STAT CG8+ cartridge on the i-STAT 1 Analyzer with investigational software using results from two (2) different fingerstick specimens from the same subject across the K measurement range.
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 (if required by the IRB)
- •≥ 18 years of age
排除标准
- •Prior enrollment in the study
研究组 & 干预措施
Precision assessment of Potassium (K) test in capillary blood sample
Other
Prospectively collected capillary specimens from two separate fingerstick blood draws.
干预措施: Fingerstick blood draw (Diagnostic Test)
结局指标
主要结局
Precision for Potassium (K) Test
时间窗: Up to 5 minutes
Clinical Evaluation of Precision for the Potassium (K) Test in Capillary Specimens using the i-STAT CG8+ Cartridge with the i-STAT 1 Analyzer
次要结局
未报告次要终点
研究者
研究点 (4)
Loading locations...
相似试验
已完成
不适用
Method Comparison Study for Measuring Potassium (K) and Ionized Calcium (iCa) in BloodPotassium (K) & Ionized Calcium (iCa) in Capillary Whole BloodNCT06295835Abbott Point of Care232
Unknown
不适用
A Clinical Study to Collect Calibration & Performance Data of the KBS Systems 1.0 Non-Invasive Glucose Monitoring DeviceDiabetesNCT03607435Florida Hospital Tampa Bay Division300
已完成
不适用
Evaluation of a Blood Potassium Measurement Device From Capillary Samples (ALPHA)Potassium MeasurementNCT04907773CardioRenal70
Unknown
不适用
A Human Clinical Study to Collect Calibration and Performance Data for the RBA-1 and KBS-1Calibration and Validation of Analyte Testing SystemNCT04305938Kaligia Biosciences, LLC1,000
已完成
不适用
Abbott i-STAT High Sensitivity Troponin I StudyMyocardial InfarctionNCT05629572Abbott Point of Care3,697