Consensus framework for developing a target product profile of real-time PCR in Chagas disease therapeutic monitoring
Alejandro G. Schijman, Colin Forsyth, Alba Abras, Igor C. Almeida, Julio Alonso-Padilla, Cristina Alonso-Vega, Cristina Ballart-Ferrer, Margarita Bisio, Constança Britto, Eric Dumonteil, María Flores-Chavez, Montserrat Gallego, Claudia P. Herrera-Bernal, Constanza Lopez-Albizu, Otacilio C. Moreira, Arturo Muñoz-Calderon, Lilian Pinto, Juan C. Ramirez, Ivan Scandale, María A. Shikanai-Yasuda, Sergio Sosa-Estani, María-Jesus Pinazo
https://journals.plos.org/plosntds/article?id=10.1371/journal.pntd.0014452

Chagas disease remains a neglected global health problem with major diagnostic and therapeutic challenges. Progression from acute to chronic infection may lead to cardiac or digestive complications in approximately 20–40% of patients, depending on geographic region and duration of follow-up. However, reliable prognostic markers are still lacking, underscoring the importance of early diagnosis and timely treatment.
For over 40 years, therapy has relied on benznidazole and nifurtimox, effective in acute but inconsistent in chronic disease, with frequent adverse effects undermining adherence. Current research is testing shorter regimens, lower doses, and novel compounds. Their evaluation is constrained by the lack of standardized biomarkers of treatment response. Serology requires decades to confirm treatment effect, whereas quantitative PCR (qPCR) enables earlier detection of therapeutic failure. However,
heterogeneity of qPCR protocols hampers cross-trial comparisons and meta-analyses. To resolve these limitations, the Drugs for Neglected Diseases initiative convened experts to build consensus on qPCR application in clinical trials aiming to define a target product profile supporting drug development and regulatory approval.

Advancing diagnostics for Chagas disease: key product characteristics and harmonized evaluation strategies – an expert meeting report
Laura C. Bohorquez, Alejandro G. Schijman, Freddy Perez, Hector Coto, Andrea Marchiol & Maria-Jesus Pinazo
https://link.springer.com/article/10.1186/s12879-026-13565-3

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.