Laboratory Protocols v1

Objective.To evaluate diagnostic precision of two rapid diagnostic tests (RDT's) on patients with chronic Chagas disease. Methodology. Prospective study with the following inclusion criteria: subjects older than 3 years, signed informed consent. Exclusion criterion: subjects could not have previously received treatment for infection with T. cruzi. The study population were participants in a screening process undertaken in rural and urban zones of the department Boyacá, Colombia. Two RDT’s were performed to all participants: the Chagas Detect Plus InBios (CDP) and the Chagas Stat-Pak (CSP) and as a reference standard the ELISA Chagas III GrupoBios and the Chagas ELISA IgG+IgM I Vircell tests wereused.In the case of discordant results between the two ELISA tests, an indirect immunofluorescence was done. Results. Three hundred-five (305) subjects were included in the study (38 patients with leishmaniasis), of which 215 tested negative for T cruzi and 90 tested positive according to the reference standard.The sensitivity of the RDT’s were 100% (CI 95% 95.9 – 100), and the specificity of the CDP was 99.1% (CI 95% 96.6 – 99.8) and for CSP was 100% (CI 95% 98.3 – 100). The agreement of CDP was 99.5% and for CSP was 100% with Kappa values of (k=99.1; CI 95% 92.6-99.8%) and (k=100; CI 95% 94.3-100), respectively. RDT’s did not present cross-reactions with samples from patients who were positive for leishmaniasis. Conclusions The findings demonstrate excellent results from the RDT’s in terms of validity, safety, and reproducibility. The results obtained provide evidence for the recommendation for using these tests in a Colombian epidemiological context principally in endemic areas in which laboratory installations necessary to perform conventional tests are not available, or they are scarce and to help in diagnosing chronic Chagas disease in order to provide access to treatment as soon as possible.