Advancing diagnostics for Chagas disease: key product characteristics and harmonized evaluation strategies - an...

Chagas disease is a global public health issue, life-threatening parasitic disease, affecting mostly underserved communities in Latin America. Yet, 10% of infected individuals are diagnosed, and 1% receive etiological treatment. Priority actions for disease elimination by 2030 are streamlining diagnostic methods and evaluating and developing point-of-care diagnostics. We convened 44 researchers, test developers, and health authorities, to provide scientific advice and reach consensus on (i) a harmonized protocol for evaluation of rapid diagnostic tests; (ii) preferred molecular diagnostics characteristics (scope, performance, operational features, pricing, and evaluation standards); and (iii) economic impact evidence needed to have a transformational impact in primary healthcare. We considered global and national perspectives with discordant evidence from multiple disciplines. Our outcomes provide a reference on practical applications and recommendations to promote test development and evaluation. Finally, we debate about the appropriate approach moving forward to meet the diagnostic gap, and propose how investments could be stimulated.