Evaluating Next Generation LAM Assays and Molecular Diagnostics (POC and Near POC) for the Diagnosis of TB Among People With Presumptive TB: a Prospective Multicentre Diagnostic Accuracy Study

This prospective multicentre study is planned to evaluate the next generation LAM assays and molecular diagnostics (POC and near POC) among people with presumptive Tuberculosis. The DriveDx4TB study aims to generate evidence needed to accelerate the introduction of three new classes of TB diagnostics, complemented by alternative sampling for use at primary healthcare and community settings. To this end, the study will leverage the accelerated innovation spurred by the COVID-19 pandemic, particularly the rapid development of swab-based sampling and molecular diagnostic (MDx) platforms.

NCT Number	NCT06019052
Lead Sponsor	Foundation for Innovative New Diagnostics, Switzerland
Conditions	Tuberculosis
Enrollment	1,890 participants
Start Date	2025-09
Primary Completion	2026-08 (estimated)
Study Completion	2026-12 (estimated)
Updated on ClinicalTrials.gov	2025-06-24