Performance Evaluation of the Molbio Diagnostics Truenat™MTB Plus/COVID-19for TB and COVID-19case Detection Using Prospectively Collected NP (Nasopharyngeal) Swabs and Sputum Samples From Participants With Symptoms Suggestive of TB
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 1,984
- 试验地点
- 1
- 主要终点
- Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19
研究概览
简要总结
This is a prospective, multicentre study in which the accuracy of the Molbio Diagnostics Truenat™ MTB (Mycobacterium tuberculosis) Plus/COVID-19multiplex will be assessed for TB and COVID-19 case detection using prospectively collected NP swabs and sputum samples from patients with symptoms suggestive of TB.
The overall study period is of 24 months which includes telephonic follow-up of the baseline COVID-19negative patients at 2 weeks and of all participants at 2 months.
详细描述
Adult patient with presumptive TB will be screened for inclusion at 4 geographically diverse participating centres in high TB burden countries. This will be the first large scale evaluation on prospectively collected fresh samples.
Telephonic follow-up visits at 2 weeks (for baseline COVID-19 negative patients) and 2 months (for all participants) after enrolment will help overcome the challenges of using MRS only. Follow-up will be conducted telephonically two weeks post-enrolment for participants who tested negative for COVID-19at enrolment to determine any change in status -this is intended to account for participants who may have tested 'early' for COVID-19at enrolment (false negative) but subsequently developed symptoms or tested COVID-19positive. Similarly, investigators will conduct a telephonic follow-up two months post-enrolment among all participants to determine if: 1) participants diagnosed with confirmed TB at enrolment were linked to treatment; and 2) assess if any new TB diagnoses were made.
This multi-center study will evaluate the performance of the Truenat™ MTB (Mycobacterium tuberculosis) Plus/COVID-19multiplex test using prospectively collected NP swabs and sputum samples from patients with symptoms suggestive of TB and collect alternative tongue swab samples for further research use. The data gathered from this study, will form part of the dossier to be submitted to WHO (world health organization) for review.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •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 * cough ≥2 weeks, fever, night sweats or unintended weight-loss
排除标准
- •Any tuberculosis preventive therapy (TPT) within 6 months prior to enrolment
- •Any anti-TB treatment within 60 days prior to enrolment (not current episode)
- •Unable to provide 3ml of sputum, nasopharyngeal and tongue swabs on Day1
- •Unable to provide all study samples before starting the 3rddose of anti-TB treatment.
结局指标
主要结局
Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19
时间窗: 2 days
Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19, with 95% confidence intervals, using the defined TB MRS
次要结局
- Estimate of the proportion of presumptive TB patients with COVID-19(2 days)
- Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19, with 95% confidence intervals, using a country-approved RT-PCR COVID-19(2 days)
- Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19multiplex for TB detection compared to Xpert Ultra among presumptive TB patients using a MRS(2 days)
- Analysis of survey responses using proportions and Linkert scale averages(2 days)
- Estimate of the proportion of TB patients (confirmed by MRS) with COVID-19(2 days)