Prospective Evaluation of Rapid Diagnostic Tests for Trypanosoma Cruzi Infection

Chagas disease (CD) is the most significant endemic zoonosis in Argentina. Two-thirds of affected individuals live in urban areas but only 10% globally are aware of their infection. Diagnosing Chronic Chagas (CCD) requires at least two serological tests, often limited to reference laboratories, creating logistical and economic challenges that delay timely diagnosis and treatment. Although primary health care (PHC) could address most health needs, the availability of Rapid Diagnostic Tests (RDTs) for CCD is limited in endemic countries due to regulatory and commercial barriers. In 2023, in a laboratory evaluation (Instituto Nacional de Parasitología, INP-ANLIS) we demonstrated that performance of six commercial RDTs available in Argentina were similar to reference methods, suggesting their potential for CCD diagnosis use (standard diagnostic", PAHO, 2018). Evaluation of RDTs in field studies across different clinical and epidemiological contexts is mandatory to provide recommendations for their use in CCD diagnosis. In this sense, independent prospective studies should be conducted to evaluate RDTs tests performances using direct blood samples under field conditions in different health care facilities and epidemiological scenarios. Moreover, trials conducted in different countries should be comparable with each other, so this protocol, produced according to STARD 2015 standards, is proposed as a complement to the PAHO (2025) recommendations. These RDT evaluation studies have the ultimate objective of incorporating them into diagnostic algorithms for better access to treatment and care strategy for patients with chronic CD.

NCT Number	NCT07304349
Lead Sponsor	Instituto Nacional de Parasitologia Dr. Mario Fatala Chaben Collaborators: National Council of Scientific and Technical Research, Argentina
Conditions	Chronic Chagas
Enrollment	3,234 participants
Start Date	2025-08-29
Primary Completion	2027-09-01 (estimated)
Study Completion	2027-09-01 (estimated)
Updated on ClinicalTrials.gov	2026-01-21