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

Author:

Ponce Carlos1,Ponce Elisa1,Vinelli Elizabeth2,Montoya Alberto3,de Aguilar Vilma4,Gonzalez Antonio5,Zingales Bianca6,Rangel-Aldao Rafael7,Levin Mariano J.8,Esfandiari Javan9,Umezawa Eufrosina S.10,Luquetti Alejandro O.11,da Silveira José Franco12

Affiliation:

1. Laboratorio Central de Referencia para Enfermedad de Chagas y Leishmaniasis, Secretaria de Salud, Tegucigalpa, Honduras

2. Cruz Roja Hondureña, Tegucigalpa, Honduras

3. Centro Nacional Diagnostico y Referencia, Ministerio de Salud, Managua, Nicaragua

4. Laboratorio Central, Ministerio de Salud Pública y Asistencia Social, San Salvador, El Salvador

5. Instituto de Parasitologia y Biomedicina, CSIC, Granada, Spain

6. Departamento de Bioquímica, Instituto de Química, Universidade de São Paulo, São Paulo, Brazil

7. Departamento de Biologia Celular, Universidad Simon Bolivar, Caracas, Venezuela

8. Instituto de Investigaciones en Engenieria Genética y Biologia Molecular (INGEBI), Buenos Aires, Argentina

9. Chembio Diagnostic Systems Inc., Medford, New York

10. Instituto de Medicina Tropical de São Paulo, Universidade de São Paulo, São Paulo, Brazil

11. Instituto de Patologia Tropical e Saúde Pública and Faculdade de Medicina, Universidade Federal de Goiás, Goiania, Brazil

12. Departamento de Microbiologia, Imunologia e Parasitologia, Escola Paulista de Medicina, UNIFESP, São Paulo, Brazil

Abstract

ABSTRACT 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.

Publisher

American Society for Microbiology

Subject

Microbiology (medical)

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