NCT02894762Unknown不适用
Performance Evaluation of In-Vitro Diagnostic Device
Lite-On Technology Corporation H.S.P.B1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2015年1月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Quantitative measurement of biochemical indicators in the blood of adult that include of Albumin (ALB), Blood urea nitrogen (BUN), Glucose (GLU), and Total Protein (TP).
研究概览
简要总结
This is an interim report for POC testing of skyla Clinical Chemistry Analyzer and four skyla Test Systems (ALB, BUN, GLU, and TP). The analyses are performed with skyla Clinical Chemistry Analyzer.
Analyte Principle:
Albumin (ALB) - Dye-Binding BCG
Blood urea nitrogen (BUN) - Urease with GLDH (coupled enzyme)
Glucose (GLU) - Hexokinase, Colorimetry
Total Protein (TP) - Biuret
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 年龄范围
- 20 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •You must be an adult over 20 years of age and weigh over 50 kg to be eligible to participate in the study.
排除标准
- •You may not participate in this study if you do not meet the above inclusion criteria.
结局指标
主要结局
Quantitative measurement of biochemical indicators in the blood of adult that include of Albumin (ALB), Blood urea nitrogen (BUN), Glucose (GLU), and Total Protein (TP).
时间窗: 6 months
Measured results will collected from the at least 120 individuals of adults for each biochemical indicator.
次要结局
未报告次要终点
研究者
研究点 (1)
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