Validating the Use of Blood Transcriptomic Signatures for the Diagnosis of Active Pulmonary Tuberculosis With the ISIT-TB Prototype in Adults Living in a High Burden Setting
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- BioMérieux
- 入组人数
- 722
- 试验地点
- 1
- 主要终点
- Evaluation of performance of the diagnostic tool
研究概览
简要总结
ISIT-TB Prototype is a diagnostic assay based on a transcriptional blood signature suggestive of the detection of Mycobacterium tuberculosis.
详细描述
This device will be investigated for use as a screening tool to facilitate diagnosis of ATB in conjunction with risk assessment, clinical context and diagnostic information. Whole blood samples will be collected in Tempus™ Blood RNA Tubes and processed on an automatized platform. The detection of a combination of under or over-expressed selected genes, constituting a transcriptional signature, will allow the characterization of ATB.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Symptoms suggestive of TB disease: cough for more than two weeks plus at least one of the following: fever, malaise, weight loss, night sweats, haemoptysis, chest pain or loss of appetite.
- •Willingness to give consent to take part in the study.
- •Aged >18 years old.
- •Healthy control : no history of TB treatment, no respiratory symptoms, no evidence of active infectious disease, no history of close contacts of active pulmonary TB patients.
排除标准
- •Pregnant woman
- •A person who has received treatment for active TB or LTBI in the past 24 months
结局指标
主要结局
Evaluation of performance of the diagnostic tool
时间窗: Time to bacteriological confirmation 60 days
Determination of the specificity and sensitivity of the diagnostic assay ISIT-TB Prototype for TB in a population living in a high-burden country
次要结局
未报告次要终点