NCT02104154终止不适用
Evaluation of the Samsung LABGEO PT10 Hepatic Panel in a Point-of-Care Setting
Samsung Electronics1 个研究点 分布在 1 个国家目标入组 32 人开始时间: 2013年11月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 32
- 试验地点
- 1
- 主要终点
- Bias between Samsung LABGEO PT10 serum results and matching FDA-cleared comparator assay
研究概览
简要总结
To establish the performance characteristics of the Samsung LABGEO PT10 by comparing the test results of the PT10 Hepatic assay with results obtained from an FDA-cleared chemistry analyzer.
详细描述
To establish the correlation between measurand values as obtained from the Samsung LABGEO PT10 Hepatic Panel at the point of care, and the corresponding measurand values as obtained on a commercial clinical chemistry analyzer, with respect to prospectively collected human serum specimens.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Male or female subjects with a history of elevated liver enzymes or symptoms suggestive of elevated liver enzymes
- •Presenting to the site and requiring testing for levels of liver enzymes as part of routine care at the site
- •Subjects able and willing to provide written informed consent
排除标准
- •Subjects unable or unwilling to provide written informed consent
- •Subjects with a life-threatening disease or any serious, potentially life-threatening medical illness that may compromise patient safety or study conduct
结局指标
主要结局
Bias between Samsung LABGEO PT10 serum results and matching FDA-cleared comparator assay
时间窗: baseline
次要结局
- Estimates of reference intervals by computing the 2.5th percentile of associated distribution of test measurement (for each analyte) and the 97.5th percentile of associated distribution.(baseline)
- Mean percentage difference between all pairs of plasma and serum measurements using Bland-Altman plot of differences.(baseline)
- Mean percentage difference between all pairs of plasma and whole blood measurements using Bland-Altman plot of differences.(baseline)
- Mean percentage difference between all pairs of serum and whole blood measurements using Bland-Altman plot of differences.(baseline)
- Standard deviation and coefficients of variation of between run, between day and total precision.(20 days)
研究者
研究点 (1)
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