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A single swab, two diseases: rapid test takes on TB and COVID-19

NCT ID NCT05405296

Diagnosis Sponsor: Foundation for Innovative New Diagnostics, Switzerland Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Sep 04, 2026 · Last updated Sep 04, 2026

Summary

Researchers are testing a portable device called Truenat MTB Plus/COVID-19 to see if it can accurately detect both tuberculosis and COVID-19 from the same sample. The study will enroll about 2,000 adults who have symptoms like a long-lasting cough, fever, or weight loss, which could point to either disease. Participants provide nose and sputum samples, and the test results are compared with standard lab methods. If the test works well, it could offer a faster, simpler way to diagnose two major respiratory infections in one go.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Truenat MTB Plus/COVID-19, a chip-based rapid PCR test that detects TB and COVID-19 from the same sample
What this could lead to
If accurate, this single test could speed up diagnosis of both TB and COVID-19, helping patients get the right treatment faster and reducing spread.
What could go wrong
The test may not be as accurate as standard lab methods, and results from this study may not apply to all settings or populations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

1,984 people

The number who actually took part.

Started

Aug 2022

Finished

Sep 2024

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

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.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

COVID-19 pulmonary tuberculosis tuberculosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

COVID-19 TB

Contacts and locations

Locations

  • Makarere University

    Kampala, Uganda

More trials for these conditions

Other studies related to the condition(s) this trial covers.