A Multi-centric Performance Evaluation of Diagnostic Accuracy of Determineâ„¢ TB LAM Ag Test, a Point-of-Care Urine Lipoarabinomannan Assay, for detection of Active Tuberculosis in People Living with HIV in India
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 5
- 主要终点
- Diagnostic performance evaluation of Determine TB LAM Ag Test
研究概览
简要总结
A Multi-centric Evaluation of Diagnostic Accuracy of Determineâ„¢ TB LAM Ag Test, a Point-of-Care Urine Lipoarabinomannan Assay, for detection of Active Tuberculosis in People Living with HIV in India.
The Determineâ„¢ TB LAM Ag Test is an in vitro, point-of-care, visually read, qualitative immunoassay for the detection of Lipoarabinomannan (LAM) antigen of Mycobacteria in human urine as an aid in the diagnosis of active TB disease. It is a urine test kit, results of which are visually read as positive or negative depending on visibility or non-visibility of a purple/ grey line, which is indicative of level of LAM antigen of Mycobacteria present in the sample.
Objective of Study - The aim of the study is to evaluate the diagnostic accuracy of the Determineâ„¢ TB LAM Ag Test, a point-of-Care urinary LAM assay, for detection of active TB disease in people living with HIV (PLHIV) with CD4 counts less than or equal to 200 cells/mm3in India.
The study has been approved by CDSCO and Expert Committee on 1st Mar 2024
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 80.00 Year(s)（—）
- 性别
- All
入选标准
- •HIV positive status and CD4 count ≤ 200 cells/ mm3.
排除标准
- •Individual currently under anti-tuberculosis treatment (ATT).
结局指标
主要结局
Diagnostic performance evaluation of Determine TB LAM Ag Test
时间窗: This is approximately 12 months study for enrolling 330 patients which we expect to start from 1st of April 2024 and complete on or before Mar 2025 and result analysis will be done within Mar/Apr 2025
次要结局
- A point-of-Care urinary LAM assay, for detection of active TB disease in people living with HIV (PLHIV) with CD4 counts less than or equal to 200 cells/mm in India(This is approximately 12 months study for enrolling 330 patients which we expect to start from 1st of April 2024 & complete on or before Mar 2025 & result analysis will be done within Mar/Apr 2025)
研究者
Dr Upasna Agarwal
National Institute Of Tuberculosis and Respiratory Diseases