evaluation of the performance of rapid diagnostic tests in point-of-care conditions for serological diagnosis of chagas disease in pregnant women in Colombia

Between 2022 and 2024, the National Institute of Health of Colombia and DNDi conducted a performance evaluation study on rapid diagnostic tests under point-of-care conditions for the serological detection of T. cruzi infection in Colombia. The main objective was to assess the performance of four rapid diagnostic tests (RDTs) under point-of-care conditions compared to Colombia’s official serological diagnostic algorithm based on enzyme-linked immunosorbent assay (ELISA). To achieve this, the performance of each RDT and combined algorithms (parallel and serial configurations) was determined. This was a prospective, observational, and analytical diagnostic study involving 771 pregnant women residing in Colombia. Whole blood samples were collected for rapid tests and serum for reference tests under standardized protocols. All participants were enrolled within the framework of the implementation of the Comprehensive Health Care Route and the Maternal-Perinatal Route of the Ministry of Health, and clinical and laboratory follow-up was guaranteed for all newborns and their mothers. Key findings revealed that the evaluated tests (STAT PAK, ADBIO, BIOLINE, and WL Check Chagas) achieved point estimates of sensitivity ranging from 88.6% to 97.5% and specificity from 98.1% to 100%. STAT PAK showed the best individual performance, and combined algorithms demonstrated promising results. Modeling of the simultaneous (parallel) use of rapid diagnostic tests yielded point estimates of sensitivity between 92.4% and 98.7% and specificity between 97.5% and 99.6%. In turn, serial models, in which a rapid test is initially applied and, if the result is positive, a second test is performed, achieved point estimates of sensitivity between 86.1% and 96.2% and specificity between 99.7% and 100%. Based on the results of this study, RDTs may be considered a valuable tool for screening T. cruzi infection in pregnant women. Selected combinations of RDTs, modeled mathematically from individual RDT results rather than prospectively implemented as diagnostic workflows, showed promising diagnostic performance. The use of RDT s for screening, combined with locally validated simplified confirmation strategies, could significantly improve access to timely diagnosis in rural and remote areas. Furthermore, it could substantially contribute to the widespread implementation of initiatives aimed at universal screening of pregnant women for Chagas disease in Colombia, thereby improving the control of mother-to-child transmission .