title: Serodiagnosis of chronic Chagas infection by using EIE-Recombinant-Chagas-Biomanguinhos kit.
abstract: A kit based on an enzyme immunoassay, EIE-Recombinant-Chagas-Biomanguinhos, developed by the Oswaldo Cruz Foundation, was evaluated for the serodiagnosis of chronic Chagas disease. Evaluation was performed with 368 serum samples collected from individuals living in an endemic area for Chagas disease: 131 patients in the chronic phase with confirmed clinical, epidemiological, and serological diagnosis (indirect immunofluorescence, indirect hemagglutination or enzyme-linked immunosorbent assay) and 237 nonchagasic seronegative individuals were considered negative control. The EIE-Recombinant-Chagas-Biomanguinhos kit showed high sensitivity, 100% (CI 95%: 96.4-100%) and high specificity, 100% (CI 95%: 98-100%). The data obtained were in full agreement with clinical and conventional serology data. In addition, no cross-reaction was observed with sera from patients with cutaneous (n=14) and visceral (n=3) leishmaniasis. However, when these sera were tested by conventional serological assays for Chagas disease, cross-reactions were detected in 14.3% and 33.3% of the patients with cutaneous and visceral leishmaniasis, respectively. No cross-reactions were observed when sera from nonchagasic seronegative patients bearing other infectious disease (syphilis, n=8; HTLV, n=8; HCV, n=7 and HBV, n=12) were tested. In addition, sera of patients with inconclusive results for Chagas disease by conventional serology showed results in agreement with clinical evaluation, when tested by the kit. These results are relevant and indicate that the referred kit provides a safe immunodiagnosis of Chagas disease and could be used in blood bank screening.
authors.affiliation: Departamento de Imunologia, Centro de Pesquisas Aggeu Magalhães, Fiocruz, Recife, PE, 50670-420, Brasil.
authors.forename: Y M
authors.initials: YM
authors.lastname: Gomes
authors.forename: V R
authors.initials: VR
authors.lastname: Pereira
authors.forename: M
authors.initials: M
authors.lastname: Nakazawa
authors.forename: D S
authors.initials: DS
authors.lastname: Rosa
authors.forename: M D
authors.initials: MD
authors.lastname: Barros
authors.forename: A G
authors.initials: AG
authors.lastname: Ferreira
authors.forename: E D
authors.initials: ED
authors.lastname: Silva
authors.forename: S F
authors.initials: SF
authors.lastname: Ogatta
authors.forename: M A
authors.initials: MA
authors.lastname: Krieger
authors.forename: S
authors.initials: S
authors.lastname: Goldenberg
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000818:Animals; D000953:Antigens, Protozoan / Q000097:blood*; D014355:Chagas Disease / Q000097:blood / Q000175:diagnosis*; D002648:Child; D002675:Child, Preschool; D002908:Chronic Disease; D006801:Humans; D007124:Immunoenzyme Techniques / Q000379:methods; D008875:Middle Aged; D011933:Reagent Kits, Diagnostic; D011994:Recombinant Proteins / Q000276:immunology*; D012680:Sensitivity and Specificity; D012698:Serologic Tests; D014349:Trypanosoma cruzi / Q000276:immunology
chemical_list: D000953:Antigens, Protozoan; D011933:Reagent Kits, Diagnostic; D011994:Recombinant Proteins