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

Affiliation: Border Biomedical Research Center, Department of Biological Sciences, University of Texas at El Paso, El Paso, Texas, United States of America Andrea Angheben Affiliation: Department of Infectious–Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, Negrar di Valpolicella, Verona, Italy Tania Araujo Jorge ¶‡ These investigators are in the Red NHEPACHA. Current methods used for monitoring Chagas disease treatment efficacy are suboptimal due to the fact that: (1) clinical progression of the disease is silent and associated with complex and mostly unknown host–pathogen interactions; (2) once in the chronic stage, infected subjects remain seropositive for years, with very low and intermittent parasitemia counts; and (3) as a consequence, in the chronic phase, parasitological detection methods have very low sensitivity, whereas molecular detection can only be done in reference laboratories. [...]the posttreatment detection of circulating parasites (through their DNA) by molecular amplification techniques, such as quantitative polymerase chain reaction (qPCR), may be useful for determining treatment failure, but a negative qPCR result cannot be considered a surrogate of cure [18]. For each of the characteristics in the TPP, specialists were asked to take into consideration both use-case scenarios. Since the requirements for a test to be used as an endpoint in