NCT01589133已完成不适用
A Multi-center Clinical Study for Assessment of the Consistency of the Results of Human Irregular Antibody Screening With Surgiscreen and Serascan Diana 3
Johnson & Johnson Medical, China4 个研究点 分布在 1 个国家目标入组 3,109 人开始时间: 2012年5月最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3,109
- 试验地点
- 4
- 主要终点
- The consistency of the results of irregular antibody screening of investigational reagent and control reagent.
研究概览
简要总结
The purpose of this study is to assess the consistency of the results of irregular antibody screening with Surgiscreen （investigational reagent) and Serascan Diana 3 (control reagent), and the consistency of the results of irregular antibody screening with investigational reagent on serum and plasma from same patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Serum or plasma samples left after routine clinical testing;
- •Blood sample of the same day, or blood samples stored at 2-8°C for 3 days after collection, or serum or plasma samples stored at -20°C for those separated 3 days after collection.
排除标准
- •Samples with severe hemolysis, jaundice or chyle-like samples;
- •Small sample size insufficient for completing the testing;
- •Samples not collected and processed upon the requirements of the instructions.
结局指标
主要结局
The consistency of the results of irregular antibody screening of investigational reagent and control reagent.
时间窗: baseline
The positive coincidence rate, the negative coincidence rate and the overall coincidence rate, as well as their respective 95% confidence interval of the irregular antibody screening results of two reagents.
次要结局
- The consistency of the results of irregular antibody screening with investigational reagent on different types of samples (serum and plasma).(baseline)
研究者
研究点 (4)
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