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

CompletedN/A

Sponsor: Foundation for Innovative New Diagnostics, Switzerland

Conditions: TB, COVID-19

Interventions: Truenat™ MTB Plus/COVID-19

Countries: Uganda

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.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

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.

Locations (1)

Kampala, Uganda