T2Bacteria Panel Pivotal Study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 2,430
- 试验地点
- 3
- 主要终点
- Specificity
研究概览
简要总结
The purpose of this study is to demonstrate the safety and effectiveness of the T2Bacteria Panel by validating the clinical performance (i.e. estimated sensitivity and specificity) of the T2Bacteria Panel compared to blood culture results and/or known Bacteria positive status of prospectively collected clinical specimens and contrived (i.e. Bacteria-spiked) whole blood "clinical samples".
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 95 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject or subject's legally authorized representative (LAR) must be able to understand, read and sign the study specific informed consent form after the nature of the study has been fully explained to them.
- •Subject has had a diagnostic blood culture ordered, per routine standard of care (prospective arm only).
- •Subject is between 18-95 years of age.
排除标准
- •Subject has other co-morbid condition(s) that, in the opinion of the Investigator, could limit the subject's ability to participate in the study or impact the scientific integrity of the study.
- •Subject has had previous specimens tested by the T2Bacteria Panel with valid results.
- •Treatment of subject with any investigational novel drug compound within 30 days prior to the collection of T2 specimens.
结局指标
主要结局
Specificity
时间窗: Up to 19 hours post blood collection
The primary endpoint of estimated specificity will be determined by comparing the negative blood culture results with the concomitantly collected T2Bacteria Panel results from the prospective clinical specimens. NPA will be estimated based on the negative contrived clinical samples.
Sensitivity
时间窗: Up to 19 hours post blood collection
The primary endpoint of estimated sensitivity will be determined by comparing positive blood culture results with the concomitantly collected T2Bacteria Panel results from the prospective clinical specimens. PPA will estimated based on the positive T2Bacteria detections of contrived clinical samples.
次要结局
未报告次要终点