NCT00552214已完成不适用
Evaluation of a TMA Assay for the Screening of HIV-1 RNA, HCV RNA and HBV DNA in Human Blood Donor Plasma Specimens
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Novartis
- 入组人数
- 10,290
- 试验地点
- 2
- 主要终点
- Sensitivity and Specificity
研究概览
简要总结
The purpose of this study is to validate the performance characteristics of an assay that tests for HIV-1, HCV and HBV on an automated blood bank instrument for registration submission.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Prevention
- 盲法
- None
入排标准
- 年龄范围
- 17 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •An acceptable blood donation health history and an EIA negative donation sample result with licensed EIA procedures in routine use at each facility
排除标准
- •A positive (reactive) HIV and/or HCV and/or HBV test
结局指标
主要结局
Sensitivity and Specificity
时间窗: 01 August 2007 to 31 December 2007
次要结局
未报告次要终点
研究者
研究点 (2)
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