Isidro Casanova

Chagas disease is a significant endemic infection in Argentina, affecting many individuals who often remain unaware of their condition. Diagnosing chronic Chagas disease typically requires multiple serological tests performed in specialized laboratories, which delays timely diagnosis and treatment. This research evaluates the use of rapid diagnostic tests (RDTs) to improve detection of chronic Trypanosoma cruzi infection in various healthcare settings and aims to support the development of a high-performance diagnostic approach using these point-of-care tests. The study is a prospective, multicenter, observational field investigation conducted at multiple health sites in Buenos Aires Province. It focuses on evaluating two commercially available rapid diagnostic tests performed at the point of care using blood samples. The study involves collecting capillary and venous blood samples for RDTs and reference serological tests. Researchers will compare RDT results to standard laboratory methods to assess accuracy, usability, and cost-effectiveness of RDT-based diagnostic algorithms. Participants include pregnant women, blood donors, transplant recipients, and others suspected of chronic infection, aged over 10 months. Throughout the 24-month period, data on clinical and epidemiological factors will be collected alongside diagnostic results. The main outcomes measured are the sensitivity, specificity, and predictive values of the RDTs compared to reference tests. Additional assessments cover test concordance across sample types, usability scores, and accessibility factors. Results will help guide recommendations for broader use of RDTs in primary health care to improve access to diagnosis and treatment for chronic Chagas disease.