NCT02687529已完成不适用
Evaluation of the 4th Generation QuantiFERON-TB Test (QFT-Plus) for the Detection of Tuberculosis Infection
QIAGEN Gaithersburg, Inc1 个研究点 分布在 1 个国家目标入组 66 人开始时间: 2015年10月27日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Number of Participants With Concordant CST001 Assay Results for All Replicates Across Three Testing Sites
研究概览
简要总结
To compare the positivity rate of the investigational assay to the currently approved QuantiFERON-TB Gold In-Tube assay.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Compensated and uncompensated members (current or future) of the Department of Veterans Affairs with no identified symptoms of active TB disease
- •Age greater than 18 years or less than 80 years.
排除标准
- •Currently taking therapy for active tuberculosis or latent TB infection for more than 14 days.
结局指标
主要结局
Number of Participants With Concordant CST001 Assay Results for All Replicates Across Three Testing Sites
时间窗: 1 day (At time of enrollment)
To demonstrate the reproducibility of the CST001 assay between 3 external laboratories with 2 operators per site.
次要结局
未报告次要终点
研究者
研究点 (1)
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