An Evaluation of New TB Diagnostic Tests (NATs) for Active Case Finding for TB in Pakistan
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 6,100
- 试验地点
- 2
- 主要终点
- Number of participants with positive and negative Mycobacterium Tuberculosis
研究概览
简要总结
This study aims to test new diagnostic methods for tuberculosis (TB) testing as compared to the existing Xpert MTB/Rif Ultra testing approach. The research questions that will be addressed by this study include:
- What are the sensitivity and specificity of the new diagnostic tests Pluslife MTBC and Ustar PortNAT for tuberculosis and how do these compare to Xpert Ultra?
- How does the new diagnostic method compare to Xpert Ultra in terms of implementation feasibility, cost and turnaround time?
- What are the logistical and technical advantages and challenges associated with implementing the new diagnostic method compared to Xpert Ultra?
- What are the perceptions of healthcare providers as well as sample provider regarding the usability, feasibility and convenience of use of the new sample collection method compared to existing methods?
详细描述
Research Objective 1:
The study aims to assess the diagnostic accuracy-specifically the sensitivity and specificity-of two new NAT-based tuberculosis (TB) tests, Pluslife and Ustar. These tests will be compared against the existing reference standard, the Xpert MTB/Rif Ultra, with culture testing used as the gold standard. This evaluation will take place in the context of Active Case Finding (ACF) in Pakistan. The research will follow a non-inferiority diagnostic trial design. The procedure involves testing all samples with cultures and comparing the results from the new NAT tests against the reference to determine their effectiveness in detecting and diagnosing TB.
Expected Outcomes:
Sensitivity of the new NAT tests Specificity of the new NAT tests False positive rate False negative rate
Research Objective 2:
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
- None
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •People who are screened for TB on X-ray with CAD and their CAD scores are available
- •Age range appropriate for the test (e.g., adult patients 12 yrs old and above)
- •Any gender
- •Consent to participate in the study and provide samples (e.g., tongue swab, sputum).
排除标准
- •Pregnant women (depending on the diagnostic method or potential risks involved).
- •Known cases of Pulmonary TB
- •People who are unable to produce sputum
- •Extra Pulmonary TB cases
- •People who are not screened for TB on X-ray and/or their CAD scores are not available
结局指标
主要结局
Number of participants with positive and negative Mycobacterium Tuberculosis
时间窗: From enrolment to the end of results confirmation at 8 weeks
The results of each of the test performed (negative and positive TB) using Pluslife MTBC test result, Ustar's PortNAT test result, Xpert MTB/Rif test result and results of the MTB culture.
次要结局
未报告次要终点