Evaluation of New TB Diagnostic Tests (NATs) in Pakistan

Launched by MERCY CORPS PAKISTAN · May 14, 2025

Keywords

ClinConnect Summary

This clinical trial is focused on testing new methods for diagnosing tuberculosis (TB) in comparison to the current standard test, called Xpert MTB/Rif Ultra. The study aims to evaluate how accurate the new diagnostic tests, Pluslife MTBC and Ustar PortNAT, are in identifying TB. It will also look at how easy and cost-effective these new tests are to use, as well as any challenges in implementing them. Additionally, healthcare providers will share their thoughts on how convenient and user-friendly the new sample collection methods are compared to what is currently being used.

To be eligible for this trial, participants must be at least 12 years old and have been screened for TB using X-ray, with available scores from a computer-aided detection system. It’s important to note that pregnant women, people with known pulmonary TB, and those who cannot produce sputum will not be able to participate. Individuals who join the study will be asked to provide samples, like a tongue swab or sputum, to help researchers gather the necessary data. This study is an important step towards improving TB diagnosis and treatment in Pakistan.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • People who are screened for TB on X-ray with CAD and their CAD scores are available
• • Age range appropriate for the test (e.g., adult patients 12 yrs old and above)
• • Any gender
• • Consent to participate in the study and provide samples (e.g., tongue swab, sputum).
• Exclusion Criteria:
• • Pregnant women (depending on the diagnostic method or potential risks involved).
• • Known cases of Pulmonary TB
• • People who are unable to produce sputum
• • Extra Pulmonary TB cases
• • People who are not screened for TB on X-ray and/or their CAD scores are not available