Evaluation of adult chronic Chagas' heart disease diagnosis by molecular and serological methods.
Chagas' disease caused by Trypanosoma cruzi is endemic in Latin America. T. cruzi presents heterogeneous populations and comprises two main genetic lineages, named T. cruzi I and T. cruzi II. Diagnosis in the chronic phase is based on conventional serological tests, including indirect immunofluorescence (IIF) and enzyme-linked immunosorbent assay (ELISA), and diagnosis in the acute phase based on parasitological methods, including hemoculture. The objective of this study was to evaluate the diagnostic procedures of Chagas' disease in adult patients in the chronic phase by using a PCR assay and conventional serological tests, including TESA-blot as the gold standard. Samples were obtained from 240 clinical chronic chagasic patients. The sensitivities, compared to that of TESA-blot, were 70% for PCR using the kinetoplast region, 75% for PCR using the nuclear repetitive region, 99% for IIF, and 95% for ELISA. According to the serological tests results, we recommend that researchers assess the reliability and sensitivity of the commercial kit Chagatest ELISA recombinant, version 3.0 (Chagatest Rec v3.0; Wiener Lab, Rosario, Argentina), due to the lack of sensitivity. Based on our analysis, we concluded that PCR cannot be validated as a conventional diagnostic technique for Chagas' disease. These data have been corroborated by low levels of concordance with serology test results. It is recommended that PCR be used only for alternative diagnostic support. Using the nuclear repetitive region of T. cruzi, PCR could also be applicable for monitoring patients receiving etiologic treatment.
Facultad de Ciencias, Departamento de Ciencias Biológicas, Centro de Investigaciones en Microbiología y Parasitología Tropical, CIMPAT, Universidad de los Andes, Carrera 1 No 18A 10, Bogotá, Colombia.
Juan David
JD
Ramírez
Felipe
F
Guhl
Eufrosina Setsu
ES
Umezawa
Carlos A
CA
Morillo
Fernando
F
Rosas
Jose A
JA
Marin-Neto
Silvia
S
Restrepo
D000328:Adult; D002598:Chagas Cardiomyopathy / Q000175:diagnosis* / Q000469:parasitology; D002908:Chronic Disease; D016054:DNA, Protozoan / Q000032:analysis / Q000302:isolation & purification; D019084:Fluorescent Antibody Technique, Indirect; D006386:Hemagglutination Tests; D006801:Humans; D007159:Immunologic Tests / Q000379:methods*; D016133:Polymerase Chain Reaction / Q000379:methods*; D011237:Predictive Value of Tests; D012680:Sensitivity and Specificity; D014349:Trypanosoma cruzi / Q000145:classification / Q000235:genetics / Q000276:immunology / Q000302:isolation & purification
D016054:DNA, Protozoan