Application of GeneXpert on Bronchoscopic Samples for Patients Suspicious of TB
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 219
- 试验地点
- 1
- 主要终点
- sensitivity, specificity, positive and negative predictive values
研究概览
简要总结
This is an observational study using Bronchial-alveolar lavage (BAL) as specimen for GeneXpert, a real time polymerase chain reaction (PCR) test for detection of tuberculosis (TB). Patients suspicious of TB, who require bronchoscopy as part of the investigation procedures, will be recruited for this study over a period of 18 months. Clinical likelihood of TB will be systematically scored according to various clinical parameters. This will determine the pre-test probability. Clinician will decide if anti-TB treatment is to be started and patients will be followed up for a minimal of 18 months. Sensitivity, specificity, positive, negative predictive values and the respective likelihood ratio will be calculated accordingly.
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
- •Patients > 18 years old suspected of TB clinically.
- •Patients suspected of TB but both smear microscopy and TB PCR of sputum are negative or sputum cannot be produced.
- •BAL samples obtained following standard investigation procedure
- •CXR or CT imaging available.
排除标准
- •Bronchoscopy is not planned as a necessary procedure for investigation.
- •Diagnosis of active TB has been made by other means.
结局指标
主要结局
sensitivity, specificity, positive and negative predictive values
时间窗: 18 months
次要结局
未报告次要终点
研究者
To Kin Wang
Honorary Clinical Assistant Professor
Chinese University of Hong Kong