Evaluation of the Truenat™MTB Plus/COVID-19 Test for TB (Tuberculosis) and COVID-19 (SARS-CoV2)

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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TB, COVID-19

Intervention / Treatment
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* Device: Truenat™ MTB Plus/COVID-19


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Intervention/Treatment |
| --- |
|Device: Truenat™ MTB Plus/COVID-19|Truenat™ MTB Plus/COVID-19is a disposable, room temperature stable, chip-based Real Time duplex PCR test, along with freeze dried PCR reagents provided in microtube for performing Real Time PCR for infectious disease and runs on the Truelab® Real Time micro-PCR Analyzer.|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19 | Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19, with 95% confidence intervals, using the defined TB MRS | 2 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19, with 95% confidence intervals, using a country-approved RT-PCR COVID-19 | Point estimates of sensitivity and specificity of Truenat™ MTB Plus/COVID-19, with 95% confidence intervals, using a country-approved RT-PCR ( real time polymerase chain reaction) 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 | 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 | 
| Estimate of the proportion of presumptive TB patients with COVID-19 | Estimate of the proportion of presumptive TB patients with COVID-19 confirmed by country-approved RT-PCR Covid-19 assay) (expressed as a percentage) | 2 days | 
| Estimate of the proportion of TB patients (confirmed by MRS) with COVID-19 | Estimate of the proportion of TB patients (confirmed by MRS) with COVID-19(confirmed by country-approved RT-PCR Covid-19 assay) (expressed as a percentage) | 2 days | 
| Analysis of survey responses using proportions and Linkert scale averages | Analysis of survey responses using proportions and Linkert scale averages | 2 days |