CTRI/2022/12/047990尚未招募不适用
Performance evaluation of the Molbio Diagnostics Truenatâ„¢ MTB Plus/COVID-19 for TB and COVID-19 case detection using prospectively collected NP swabs and sputum samples from patients with symptoms suggestive of TB.
FIND India1 个研究点 分布在 1 个国家目标入组 1,480 人开始时间: 2022年9月12日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 1,480
- 试验地点
- 1
- 主要终点
- Point estimates of sensitivity and specificity of Truenatâ„¢ MTB Plus/COVID-19, with 95% confidence intervals, using the defined TB MRS
研究概览
简要总结
Tuberculosis (TB) remains a major public health problem globally, compounded by the ongoing Covid-19 pandemic.
Truenat® MTB Plus/SARS-CoV2 multiplex, can detect both diseases.
Goal is to determine the performance of Truenat® MTB Plus/SARS-CoV2 multiplex for TB and Covid-19 case detection using prospectively collected swabs and sputum samples. Data generated will be presented to WHO for review
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Adult (>_ 18 years) and
- •Able to provide written informed consent in their chosen language; and
- •Self-report at least one or more symptoms suggestive of pulmonary TB; and
- •Willing to return for a day 2 visit
- •Willing to provide oral swab samples for biobanking.
排除标准
- •Any tuberculosis preventive therapy (TPT) within 6 months prior to enrolment
- •Unable to provide 3ml of sputum, nasopharyngeal and tongue swabs on Day1
- •Unable to provide all study samples before starting the 3rd dose of anti-TB treatment.
结局指标
主要结局
Point estimates of sensitivity and specificity of Truenatâ„¢ MTB Plus/COVID-19, with 95% confidence intervals, using the defined TB MRS
时间窗: 3-24 months
次要结局
- Point estimates of sensitivity & specificity of truenat MTB Plus/COVID-19 with 95% confidence intervals, using the defined covid 19 country approved rt pcr covid 19 assay(3-24 months)
- Analysis of survey responses using proportions and linkert scale averages(3-24 months)
- Estimates of the proportion of presumptive tb patients with covid 19 confirmed by MRS (expressed as a percentage)(3-24 months)
- Estimates of the proportion of TB patients (confirmed by MRS) with COVID 19 confirmed by MRS (expressed as a percentage)(3-24 months)
- Point estimates of sensitivity & specificity of Truenat MTB Plus/COVID-19 multiplex for TB detection compared to Xpert Ultra among presumptive TB patients using a MRS(3-24 months)
研究者
研究点 (1)
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