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Journal of Clinical Microbiology, October 2005, p. 5065-5068, Vol. 43, No. 10
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.10.5065-5068.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.

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

Carlos Ponce,1 Elisa Ponce,1 Elizabeth Vinelli,2 Alberto Montoya,3 Vilma de Aguilar,4 Antonio Gonzalez,5 Bianca Zingales,6 Rafael Rangel-Aldao,7 Mariano J. Levin,8 Javan Esfandiari,9 Eufrosina S. Umezawa,10 Alejandro O. Luquetti,11 and José Franco da Silveira12*

Laboratorio Central de Referencia para Enfermedad de Chagas y Leishmaniasis, Secretaria de Salud, Tegucigalpa, Honduras,1 Cruz Roja Hondureña, Tegucigalpa, Honduras,2 Centro Nacional Diagnostico y Referencia, Ministerio de Salud, Managua, Nicaragua,3 Laboratorio Central, Ministerio de Salud Pública y Asistencia Social, San Salvador, El Salvador,4 Instituto de Parasitologia y Biomedicina, CSIC, Granada, Spain,5 Departamento de Bioquímica, Instituto de Química, Universidade de São Paulo, São Paulo, Brazil,6 Departamento de Biologia Celular, Universidad Simon Bolivar, Caracas, Venezuela,7 Instituto de Investigaciones en Engenieria Genética y Biologia Molecular (INGEBI), Buenos Aires, Argentina,8 Chembio Diagnostic Systems Inc., Medford, New York,9 Instituto de Medicina Tropical de São Paulo, Universidade de São Paulo, São Paulo, Brazil,10 Instituto de Patologia Tropical e Saúde Pública and Faculdade de Medicina, Universidade Federal de Goiás, Goiania, Brazil,11 Departamento de Microbiologia, Imunologia e Parasitologia, Escola Paulista de Medicina, UNIFESP, São Paulo, Brazil,12

Received 9 March 2005/ Returned for modification 14 June 2005/ Accepted 8 July 2005

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

* Corresponding author. Mailing address: Department Microbiology, Immunology and Parasitology, Escola Paulista de Medicina/UNIFESP, Rua Botucatu 862, CEP 04023-062, São Paulo SP, Brazil. Phone: 55 11 55 76 45 32. Fax: 55 11 55 71 10 95. E-mail: franco{at}ecb.epm.br.

Journal of Clinical Microbiology, October 2005, p. 5065-5068, Vol. 43, No. 10
0095-1137/05/$08.00+0     doi:10.1128/JCM.43.10.5065-5068.2005
Copyright © 2005, American Society for Microbiology. All Rights Reserved.



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