SWAB -IMPACT · SWAB-IMPACT: Swab-Based Molecular Testing for Impact on TB Diagnosis and Treatment

Earlier more accessible tuberculosis (TB) diagnosis and treatment is vital to achieve global targets for TB elimination. A key challenge in high TB burden settings is the current diagnostic approach at primary care level. Despite substantial investment in molecular diagnostics for TB, current tests are too expensive and complex to implement near patients and rely on sputum which many people cannot produce. Therefore, samples are referred to regional ‘hub’ laboratories, leading to delays of several days and contributing to significant loss to follow up, morbidity and mortality. SWAB-IMPACT will address this challenge by implementing an innovative swab-based molecular TB test (Pluslife MiniDock MTB), which is accurate, fast, low-cost, simple and battery-operated, thus meeting the WHO targets for true point-of-care (POC) testing. Over 36 months, this project will (1) establish the effectiveness of this approach in improving TB diagnosis and treatment in primary care clinics through a cluster randomised controlled trial, (2) assess implementation feasibility of POC swab-based molecular testing through mixed methods, and (3) estimating the incremental cost, cost-effectiveness and budget impact of swab-based molecular testing. The project will take place in Zambia and South Africa, both high TB burden settings, and leverage a European-African partnership with experience in clinical trials, diagnostic development, implementation science and health economics. We envisage substantial impact on policy making by generating the evidence required for local adoption and scale-up in project-countries. Furthermore, we aim to accelerate the deployment of this transformative POC diagnostic solution in sub-Saharan Africa for other public health challenges by demonstrating a scalable model for TB.