To study the performance of Truenat machine to detect COVID-19 and TB simultaneously from the same sample
Not Applicable
- Conditions
- Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhereHealth Condition 2: A150- Tuberculosis of lung
- Registration Number
- CTRI/2022/12/047990
- Lead Sponsor
- FIND India
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1. Adult ( >_ 18 years) and
2. Able to provide written informed consent in their chosen language; and
3. Self-report at least one or more symptoms suggestive of pulmonary TB; and
4. Willing to return for a day 2 visit
5. Willing to provide oral swab samples for biobanking
Exclusion Criteria
1. Any tuberculosis preventive therapy (TPT) within 6 months prior to enrolment
2. Any anti-TB treatment within 60 days prior to enrolment (not current episode)
3. Unable to provide 3ml of sputum, nasopharyngeal and tongue swabs on Day1
4. Unable to provide all study samples before starting the 3rd dose of anti-TB treatment.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Point estimates of sensitivity and specificity of Truenatâ?¢ MTB Plus/COVID-19, with 95% confidence intervals, using the defined TB MRSTimepoint: 3-24 months
- Secondary Outcome Measures
Name Time Method Analysis of survey responses using proportions and linkert scale averagesTimepoint: 3-24 months;Estimates of the proportion of presumptive tb patients with covid 19 confirmed by MRS (expressed as a percentage)Timepoint: 3-24 months;Estimates of the proportion of TB patients (confirmed by MRS) with COVID 19 confirmed by MRS (expressed as a percentage)Timepoint: 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 MRSTimepoint: 3-24 months;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 assayTimepoint: 3-24 months