Validation of a Rapid and Reliable Test for Diagnosis of Chagas' Disease by Detection of Trypanosoma cruzi-Specific Antibodies in Blood of Donors and Patients in Central America

摘要

In this study we compared the performance of the Chagas Stat-Pak rapid immunochromatographic test with\uda standard enzyme-linked immunosorbent assay (ELISA) in the serodiagnosis of Chagas’ disease in Central\udAmerica. Out of 3,400 blood donor samples, 156 (4.6%) were positive in both assays. Three sera out of 2,084\udsamples from reference laboratories were negative with the rapid test but positive with the ELISA (99.8%\udagreement). Agreement of 100% between the two tests was observed with 339 additional sera from patients with\udcardiopathies and 175 sera from potential blood donors in emergency surgical cases occurring on weekends or\udat night. In conclusion, Chagas Stat-Pak showed 99.6% and 99.9% sensitivity and specificity, respectively, when\udassayed with 5,998 serum samples. It is a sensitive and specific alternative to the ELISA, as required in medical\udemergencies and blood screenings in Central America.