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Can a chest X-Ray and blood test quickly rule out TB?

NCT ID NCT04666311

Diagnosis Sponsor: Klaus Reither 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 26, 2026 · Updated 1 time

Summary

This study tested two new tools for diagnosing tuberculosis (TB): a software that analyzes chest X-rays (CAD4TB) and a blood test that measures C-reactive protein (CRP). Researchers enrolled 1,400 adults with TB symptoms in Lesotho and South Africa. They compared these tests to standard lab methods to see if they could accurately rule out TB. The goal is to find a fast, affordable way to screen for TB in busy clinics.

What this could mean

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

Active substance
CAD4TB software and Afinion CRP blood test
What this could lead to
If successful, these tests could provide a quick, low-cost way to rule out TB in clinics, reducing the need for more complex lab tests.
What could go wrong
This is a completed accuracy study, not a treatment trial. The tests may not be sensitive enough in all settings, and results may not apply to everyone.

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

1,400 people

The number who actually took part.

Started

Feb 2021

Finished

Aug 2022

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

Adult presumptive TB cases (age ≥18years) with one or more TB symptoms (WHO recommended four-symptom screening; cough, weight loss, night sweats, fever) of any duration. Presumptive TB patients will be recruited (i) at the outpatient departments of the Butha-Buthe District Hospital (Butha-Buthe, Lesotho) and the Caluza Clinic (Pietermaritzburg, KwaZulu-Natal, South Africa) and (ii) during community-based health campaigns by SolidarMed in Lesotho and HSRC in South Africa.

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: 1. Willing and able to provide signed written consent or witnessed oral consent in the case of illiteracy, prior to undertaking any study-related procedure 2. Adults (≥18 years) 3. Any of the cardinal symptoms of TB (cough, weight loss, night sweats, fever) of any duration Exclusion Criteria: 1. Pregnancy (based on oral information from participant) 2. Any condition for which participation in the study, as judged by the investigator, could compromise the well-being of the subject or prevent, limit or confound protocol specified assessments 3. Critically sick patients who need immediate medical care 4. Current anti-TB treatment

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Conditions

The condition(s) this trial relates to.

Alagille syndrome COVID-19 HIV infectious disease pulmonary tuberculosis tuberculosis

As listed by the trial registrant

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

COVID -19 HIV Pulmonary tuberculosis Tuberculosis diagnosis

Contacts and locations

Locations

  • Butha-Buthe District Hospital

    Butha-Buthe, Lesotho

  • Caluza Clinic

    Pietermaritzburg, KwaZulu-Natal, South Africa

More trials for these conditions

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