[Serological diagnosis of Chagas disease: self-sufficiency and interlaboratory concordance]

Abstract

American trypanosomiasis (Chagas' disease) is becoming a relatively common condition in North America. Diagnosis at the chronic stage depends on demonstration of specific antibodies in body fluids, since parasitologic or pathologic diagnosis is uncertain at this stage. Therefore, standardization of immunodiagnostic techniques is mandatory, and it depends on antigen quality. Locally prepared antigens and crude extracts obtained from Mexican isolates, -both from infected vector and human cases-were compared using three different immunodiagnostic assays-indirect immunofluorescence, hemagglutination and enzyme linked immunosorbent assay (ELISA)-at two different laboratories from the Instituto Nacional de Cardiología and the Instituto Nacional de Diagnóstico y Referencia Epidemiológicos. Concordance between laboratories reached a significant Kappa value (0.8) and sensitivity, specificity and predictive values of individual diagnostic assays were adequate to use these tests in clinical diagnoses. This is the first attempt to standardize immunodiagnostic techniques in Mexico.