NCT05405296Completed
Evaluation of the Truenat™MTB Plus/COVID-19 Test for TB (Tuberculosis) and COVID-19 (SARS-CoV2)
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
Source: ClinicalTrials.gov · Last updated 4 Sept 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Observational
- Enrollment
- 1984 (actual)
- First submitted
- 3 Jun 2022
- Start date
- 30 Aug 2022
- Primary completion date
- 30 Apr 2024
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Diseases
- Tuberculosis
- NCT number
- NCT05405296
What you commit to
- Study type: Observational
- Participants enrolled: 1984
- From 30 Aug 2022 to the primary completion date, 30 Apr 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Any tuberculosis preventive therapy (TPT) within 6 months prior to enrolment
- Any anti-TB treatment within 60 days prior to enrolment (not current episode)
Other
- 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.
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Makarere University Coordinator of this site? Confirm its status | Kampala | Uganda | Unknown status |
Related publications
- Diagnostic accuracy study of the multiplex Truenat MTB Ultima/COVID-19 assay for simultaneous detection of Tuberculosis and SARS-CoV2 (COVID-19).PLOS Glob Public Health · 2026 · PMID 42247451
This page is information, not medical advice. Discuss any trial with your doctor.