TBTruenat COMBONCT05405296
Evaluation of the Truenat™MTB Plus/COVID-19 Test for TB (Tuberculosis) and COVID-19 (SARS-CoV2)
An observational study of TB and COVID-19, run by Foundation for Innovative New Diagnostics, Switzerland at 1 site in Uganda.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- What is being tested?
- Truenat™ MTB Plus/COVID-19
- Type of treatment
- Medical device
- How many people
- 1,984 participants
- Where
- 1 siteUganda
- Study dates
- 30 Aug 2022to 30 Sep 2024
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The study focuses on adults with presumptive TB. Study sites are selected to maximize the generalizability of evidence generated based on the following criteria: 1) TB incidence ≥100 per 100,000 population; 2) HIV prevalence; 3) ongoing community transmission of COVID-19; and 4) laboratory and clinical study infrastructure to support participant recruitment. Location: the study will take place in 4different countries: South Africa, Uganda, Peru, India Prospective approval of protocol deviations to recruitment and enrolment criteria, also known as protocol waivers or exemptions, are not permitted.
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the detailed description
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.
- Being tested
- Truenat™ MTB Plus/COVID-19
- Medical subject headings
- COVID-19
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Truenat™ MTB Plus/COVID-19Device
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 being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 days
Secondary outcomes (5)
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
Measured: 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
Measured: 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)
Measured: 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)
Measured: 2 days
Analysis of survey responses using proportions and Linkert scale averages
Analysis of survey responses using proportions and Linkert scale averages
Measured: 2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2022
- Study start30 Aug 2022
- Primary completion30 Apr 2024
- Study completion30 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for TBStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,984 participants (actual)
Sponsor and investigators
- Lead sponsor
- Foundation for Innovative New Diagnostics, Switzerland
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05405296
- Sponsor's protocol ID
- TB050
- Acronym
- Truenat COMBO
- Status last verified
- Sep 2025
- First submitted
- 3 Jun 2022
- Last updated
- 4 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Tootla H, Szekely R, Sserubiri J, Zemanay W, Patidar M, Joloba M, Ugarte-Gil C, Ruhwald M, Purohit M, Cox H, Zamudio C, Ssengooba W, Penn-Nicholson A; COMBO study team. 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 Jun 5;6(6):e0005859. doi: 10.1371/journal.pgph.0005859. eCollection 2026.
PubMed 42247451Inbaraj LR, Daniel J, Sathya Narayanan MK, Srinivasalu VA, Bhaskar A, Scandrett K, Rajendran P, Kirubakaran R, Shewade HD, Malaisamy M, Padmapriyadarsini C, Takwoingi Y. Truenat MTB assays for pulmonary tuberculosis and rifampicin resistance in adults and adolescents. Cochrane Database Syst Rev. 2025 Mar 24;3(3):CD015543. doi: 10.1002/14651858.CD015543.pub2.
PubMed 40122135