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

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.

Transmission of Tropical and Geographically Restricted Infections during Solid-Organ Transplantation

“…Finally, there are new rapid serological tests that use recombinant proteins in an immunochromatography cassette test with high sensitivity (99%) and specificity (99%), which may be used in emergency situations such as in the hours preceding a transplant procedure (231,296).…”

Enfermedad de Chagas en Nicaragua: actualidades

“…Recientemente se encontró que la prevalencia de la enfermedad de Chagas en Centroamérica se aproxima al 7% (Ponce et al 2005). ésta fue descrita por primera vez en Nicaragua en el año 1971.…”

“…Según este estudio, el test inmunocromatográfico tiene una especificidad y sensibilidad similar a la del ELISA y es una alternativa para el diagnóstico en una emergencia transfusional (Ponce et al 2005).…”

Advances in Serological Diagnosis of Chagas' Disease by Using Recombinant Proteins

“…96%. (Ponce et al, 2005;Brutus et al, 2008;Roddy et al, 2008;Sosa-Estani et al, 2008) The fundamental problems of T. cruzi infection serological diagnostic methods are the lack of reproducibility that sometimes occur, deficient immunological reaction specificity, what produces false-positive results, and the occasional insufficient sensitivity translated into false-negative outcomes. Chagasic infection serology tests may produce cross-reactions with antibodies produced during the course of other illnesses.…”

“…(Saez-Alquezar et al, 1997) Recently, one very fast technique with a different format has been developed namely, lateral chromatography. (Ponce et al, 2005;Barfield et al, 2011) This methodology uses small volume samples such as one serum drop, and allows acquiring results in 15 min, therefore being useful to perform the test in the field, without the need of refrigerator to preserve the reagents. Several multicenter studies have demonstrated that a commercial lateral chromatography kit show more than 92% sensitivity, whereas specificity is ca.…”