TBDx Feasibility Study: Prospective Study to Determine the Feasibility of Automated Smear Microscopy
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 572
- 试验地点
- 2
- 主要终点
- Performance of TBDx compared to culture
研究概览
简要总结
The purpose of this study will be to determine the performance characteristics of TBDx with culture as a gold standard. In addition, the investigators will assess the laboratory technicians' appraisal and technical suitability of the TBDx system.
详细描述
This will be a blinded, prospective study to determine the performance of the TBDx system for detection of pulmonary TB in comparison to LED microscopy and culture as a gold standard. The study will involve recruitment of 300 TB suspects per site with a high workload and experienced technicians. Participants will be recruited under the FIND TB Reference Materials project and leftover sputum samples used for the assessment of the TBDx.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Diagnostic
- 盲法
- Double (Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Persistent cough (>2 weeks) and at least one other typical symptom of pulmonary TB (fever, night sweats, malaise, recent weight loss, contact with active case, hemoptysis, chest pain, loss of appetite)
- •Provision of informed consent (FIND TB Reference Materials)
- •Provision of sputum for adequate testing
排除标准
- •Patients receiving any anti-TB medication, in the 60 days prior to testing.
- •Patients with only extra-pulmonary disease
研究组 & 干预措施
TBDx
All samples were tested with TBDx and compared with smear microscopy and Xpert MTB/RIF using solid and liquid culture as gold standard.
Operators were blinded to all other results for a sample upon data entry.
干预措施: TBDx (Device)
结局指标
主要结局
Performance of TBDx compared to culture
时间窗: 6 months
Sensitivity, specificity and predictive values of TBDx compared to two solid (Löwenstein Jensen) and two liquid (MGIT) cultures
次要结局
- Training needs through questionnaire assessment(6 months)
- User appraisal regarding ease of use, hands-on-time and perceived benefit through appraisal questionnaire(6 months)
- Comparison of performance of TBDx on direct vs concentrated smear(6 months)
- Performance of TBDx in combination with Xpert MTB/RIF through analysis of two different algorithms(6 months)
- Identify potential difficulties for implementation through observation and user appraisal(6 months)