JCM Accepts, published online ahead of print on 21 October 2009

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J. Clin. Microbiol. doi:10.1128/JCM.01601-09
Copyright (c) 2009, American Society for Microbiology and/or the Listed Authors/Institutions. All Rights Reserved.

EVALUATION OF ADULT CHRONIC CHAGAS HEART DISEASE DIAGNOSIS BY MOLECULAR AND SEROLOGICAL METHODS

Juan David Ramírez, Felipe Guhl^*, Eufrosina Setsu Umezawa, Carlos A. Morillo, Fernando Rosas, Jose A. Marin-Neto, and Silvia Restrepo

Centro de Investigaciones en Microbiología y Parasitología Tropical – CIMPAT – Facultad de Ciencias – Departamento de Ciencias Biológicas – Universidad de los Andes – Carrera 1 N° 18A 10 Bogotá – Colombia; Instituto de Medicina Tropical de Sao Paulo, Faculdade de Medicina da Universidade de São Paulo, CEP 05403-000, São Paulo – Brasil; McMaster University, Population Health Research Institute, Hamilton, Ontario, Canada; Electrofisiología – Clínica Abood Shaio – Bogotá – Colombia; Department of Internal Medicine, Medical School of Ribeirão Preto, Universidade de São Paulo, AV Bandeirantes, 3900 Ribeirão Preto, São Paulo, Brazil 14048-900; Laboratorio de Micología y Fitopatología Universidad de los Andes – LAMFU- Facultad de Ciencias – Departamento de Ciencias Biológicas – Universidad de los Andes – Carrera 1 N° 18A 10 Bogotá – Colombia

^* To whom correspondence should be addressed. Email: fguhl{at}uniandes.edu.co.

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. The diagnosis in the chronic phase is based on conventional serological tests including IIF and ELISA, and in the acute phase based on parasitological methods, including hemoculture. The objective of this study is to evaluate the diagnostic procedures of Chagas disease in adult patients in the chronic phase 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 using TESA-blot were 70% for PCR using the kinetoplast region and 75% using nuclear repetitive region, 99% by IIF and 95% by 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 the low concordance values with serology tests. It is recommended that PCR be used only as an alternative diagnostic support. Using the nuclear repetitive region of T. cruzi, PCR could also be applicable for monitoring patients receiving etiologic treatment.