NCT02256839已完成不适用
Evaluation of the 4th Generation QuantiFERON-TB Gold Test (CST001) for the Detection of Tuberculosis Infection
QIAGEN Gaithersburg, Inc1 个研究点 分布在 1 个国家目标入组 268 人开始时间: 2014年10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
- 268
- 试验地点
- 1
- 主要终点
- Clinical Specificity of the CST001 Assay as Measured by the Number of Correctly Identified Actual Negatives
研究概览
简要总结
To compare the results of the investigational test to the currently approved QuantiFERON-TB Gold In-Tube test.
详细描述
To compare the specificity of the CST001 assay to the QFT Gold Test in low TB exposure risk subjects and non-tuberculosis mycobacterial infections.
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
- 是
入选标准
- •No identified risk factors for TB infection
排除标准
- •Age less than 18 years or greater than 80 years
- •Identified Risk Factors For TB Infection
- •Non-tuberculous mycobacterial infection Group
- •Inclusion Criteria:
- •history of nontuberculous mycobacterial disease (pulmonary or extrapulmonary) in accordance with the 2007 ATS/IDSA criteria
- •Exclusion Criteria:
- •Age less than 18 years or greater than 80 years
- •Identified Risk Factors For TB Infection
结局指标
主要结局
Clinical Specificity of the CST001 Assay as Measured by the Number of Correctly Identified Actual Negatives
时间窗: 1 day (At time of enrollment)
To compare the clinical specificity of the CST001 assay to the QuantiFERON-TB Gold test in low TB exposure risk subjects and non TB infected subjects based on an assessment of known risk factors. These subjects had no identified risk factors of TB infection.
次要结局
未报告次要终点
研究者
研究点 (1)
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