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To study the performance of Truenat machine to detect COVID-19 and TB simultaneously from the same sample

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.

Status
Active, not recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2022/12/047990
Enrollment
1480
Registered
2022-12-08
Start date
Unknown
Completion date
Unknown
Last updated
2023-01-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: B972- Coronavirus as the cause of diseases classified elsewhere Health Condition 2: A150- Tuberculosis of lung

Interventions

Intervention1: Truenatâ?¢ MTB Plus/COVID-19 multiplex: Truenatâ?¢ MTB Plus/COVID-19 multiplex, capable of diagnosing TB and COVID diseases in one test. Test requires a combined Naso-Pharyngeal (NP) sw

Sponsors

FIND India
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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—

Countries

India, Peru, South Africa, Uganda

Contacts

Public ContactDr Manjuraj Purohit

R. D. Gardi Medical College

manjuraj.purohit64@gmail.com9425093572

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026