Information

The DriveDx4TB TOO study is a prospective, multicenter diagnostic accuracy trial designed to evaluate the performance of next-generation LAM assays and molecular diagnostic tests—specifically those categorized as near Point-of-Care (POC) and low-complexity nucleic acid amplification tests (NAATs)—for the diagnosis of tuberculosis (TB) in individuals with presumptive TB. The study aims to assess the accuracy, operational feasibility, and potential programmatic impact of these novel diagnostic tools across diverse clinical settings, comparing them with standard reference tests to support evidence-based implementation in TB control programs.

The Aurum Institute, NPC (Sponsor)

Unitaid (Grant)

SD Biosensor (IP Manufacturer)

Ustar (IP Manufacturer)

RS Persahabatan (Site)

Puskesmas Duren Sawit (Site)

Type of Study

Stakeholders Involved

Diagnostic Accuracy Study

Background

Recent innovations—accelerated by the COVID-19 pandemic—have introduced new opportunities for non-sputum sampling and decentralized molecular diagnostics, including next-generation point-of-care (POC) LAM assays, near-POC molecular diagnostics using tongue swabs, and low-complexity nucleic acid amplification tests (NAATs). However, independent evidence on the diagnostic accuracy and usability of these technologies in real-world settings remains limited. The DriveDx4TB TOO study addresses this gap by prospectively evaluating these three diagnostic technology classes using samples from adults with presumptive pulmonary TB, including people living with HIV, to generate robust data that will inform national adoption, support product dossier submissions to WHO and other stakeholders, and accelerate the introduction of improved TB diagnostics in high-burden settings.

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