A Multi-Site Clinical Evaluation of the ARIES Clostridium Difficile Assay in Symptomatic Patients
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 1,021
- 试验地点
- 4
- 主要终点
- Diagnostic accuracy will be a composite expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).
研究概览
简要总结
The ARIES C. difficile Assay is a real-time PCR based qualitative in vitro diagnostic test for the direct detection of C. difficile nucleic acid in stool specimens.
详细描述
The ARIES C. difficile Assay is a real-time polymerase chain reaction (PCR) based qualitative in vitro diagnostic test for the direct detection of Clostridium difficile (C. difficile) nucleic acid in unformed (liquid or soft) stool specimens obtained from patients suspected of having Clostridium difficile associated disease (CDAD).
The objective of this study is to establish diagnostic accuracy of ARIES C. difficile Assay through a multi-site, method comparison on prospectively collected, left-over, stool specimens. Diagnostic accuracy will be expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).
研究设计
- 研究类型
- Observational
- 观察模型
- Case Only
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •The specimen is from a patient suspected of having C. difficile associated disease (CDAD).
- •The subject's specimen is an unpreserved, unformed (liquid or soft) stool submitted for testing at the site.
排除标准
- •The specimen is preserved.
- •The specimen was not properly collected, transported, processed or stored according to the instructions provided by the sponsor.
结局指标
主要结局
Diagnostic accuracy will be a composite expressed in terms of clinical sensitivity (or positive agreement) and specificity (or negative agreement).
时间窗: Within the first year of sample collection
次要结局
未报告次要终点