Target product profile for a test for the early assessment of treatment efficacy in Chagas disease patients: An expert consensus

by Alonso-Padilla J, Abril M, Alarcón de Noya B, Almeida IC, Angheben A, Araujo Jorge T, Chatelain E, Esteva M, Gascón J, Grijalva MJ, Guhl F, Hasslocher-Moreno AM, López MC, Luquetti A, Noya O, Pinazo MJ, Ramsey JM, Ribeiro I, Ruiz AM, Schijman AG, Sosa-Estani S, Thomas MC, Torrico F, Zrein M, Picado A. PLOS Neglected Tropical Diseases 2020, 14(4): e0008035. doi: 10.1371/journal.pntd.0008035

Summary: Only a small fraction of patients with Chagas disease are properly diagnosed and treated. Currently, there is no test for the early assessment of treatment efficacy. Development of a test to determine in a timely manner whether a patient with Chagas disease has successfully responded to treatment has been identified as a priority. The authors present a target product profile (TPP) specifically describing the technical and performance characteristics required. Two use scenarios are considered: day-to-day healthcare provision, and clinical evaluation of new anti-Tcruzi drugs or alternative regimens of currently available drugs. The TPP described in this article can guide the development and uptake of these tests, which will be fundamental both to managing patients and evaluating new drugs or regimens.

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