title: 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.
authors.affiliation: Laboratorio Central de Referencia para Enfermedad de Chagas y Leishmaniasis, Secretaria de Salud, Tegucigalpa, Honduras.
authors.forename: Carlos
authors.initials: C
authors.lastname: Ponce
authors.forename: Elisa
authors.initials: E
authors.lastname: Ponce
authors.forename: Elizabeth
authors.initials: E
authors.lastname: Vinelli
authors.forename: Alberto
authors.initials: A
authors.lastname: Montoya
authors.forename: Vilma
authors.initials: V
authors.lastname: de Aguilar
authors.forename: Antonio
authors.initials: A
authors.lastname: Gonzalez
authors.forename: Bianca
authors.initials: B
authors.lastname: Zingales
authors.forename: Rafael
authors.initials: R
authors.lastname: Rangel-Aldao
authors.forename: Mariano J
authors.initials: MJ
authors.lastname: Levin
authors.forename: Javan
authors.initials: J
authors.lastname: Esfandiari
authors.forename: Eufrosina S
authors.initials: ES
authors.lastname: Umezawa
authors.forename: Alejandro O
authors.initials: AO
authors.lastname: Luquetti
authors.forename: José Franco
authors.initials: JF
authors.lastname: da Silveira
mesh_terms: D000818:Animals; D000913:Antibodies, Protozoan / Q000097:blood*; D001782:Blood Donors; D002489:Central America; D014355:Chagas Disease / Q000175:diagnosis* / Q000469:parasitology; D006801:Humans; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012698:Serologic Tests; D013997:Time Factors; D014349:Trypanosoma cruzi / Q000276:immunology*
chemical_list: D000913:Antibodies, Protozoan; D011933:Reagent Kits, Diagnostic