title: Immunoenzymatic assay for the diagnosis of American tegumentary leishmaniasis using soluble and membrane-enriched fractions from infectious Leishmania (Viannia) braziliensis.
abstract: The diagnosis of American tegumentary leishmaniasis (ATL) is based on the visualization or isolation of the parasite, which is a time-consuming and poorly sensitive method. In this study, we evaluated the accuracy and reliability of ELISA for the diagnosis of ATL using soluble (SF) and membrane-enriched (MF) antigen fractions obtained from an infectious strain of Leishmania (Viannia) braziliensis. A total of 152 serum samples investigated at a referral center in Rio de Janeiro, Brazil, between 2005 and 2007 were studied. Each sample was tested twice with each fraction for the calculation of reliability (intraclass coefficient (ICC)). Cut-off values of 0.22 (SF) and 0.33 (MF) were defined. The use of the fractions resulted in good discrimination between patients, with a large area under the curve (P<0.0001), but no difference was observed between the two fractions (P=0.45). Sensitivity was 89.5% for each fraction, specificity was 89.5% for SF and 93.4% for MF, and the positive likelihood ratio was 8.5 for SF and 13.6 for MF. The ICCs were excellent (SF: 0.96 and MF: 0.90). The antigens tested provided precision and accuracy for the diagnosis of ATL, with SF being recommended due to its lower cost and greater practicality.
authors.affiliation: Laboratório de Vigilância em Leishmanioses, Instituto de Pesquisa Clínica Evandro Chagas, FIOCRUZ, Rio de Janeiro, Brazil. jamyra.iglesias@ipec.fiocruz.br
authors.forename: Jamyra Iglesias
authors.initials: JI
authors.lastname: Cataldo
authors.forename: Fernanda Carvalho
authors.initials: FC
authors.lastname: de Queiroz Mello
authors.forename: Eliame
authors.initials: E
authors.lastname: Mouta-Confort
authors.forename: Maria
authors.initials: M
authors.lastname: de Fátima Madeira
authors.forename: Armando
authors.initials: A
authors.lastname: de Oliveira Schubach
authors.forename: Marcelo
authors.initials: M
authors.lastname: da Silva Genestra
authors.forename: Flávia Coelho
authors.initials: FC
authors.lastname: Ribeiro
authors.forename: Célia
authors.initials: C
authors.lastname: de Fátima Moreira-Venâncio
authors.forename: Sônia Regina Lambert
authors.initials: SR
authors.lastname: Passos
mesh_terms: D000328:Adult; D000913:Antibodies, Protozoan / Q000097:blood*; D000953:Antigens, Protozoan / Q000276:immunology*; D001938:Brazil; D016022:Case-Control Studies; D002462:Cell Membrane / Q000276:immunology*; D003600:Cytosol / Q000276:immunology*; D004797:Enzyme-Linked Immunosorbent Assay; D005260:Female; D006801:Humans; D007892:Leishmania braziliensis / Q000276:immunology*; D016773:Leishmaniasis, Cutaneous / Q000175:diagnosis* / Q000276:immunology / Q000469:parasitology; D008297:Male; D011379:Prognosis; D012372:ROC Curve; D012680:Sensitivity and Specificity
chemical_list: D000913:Antibodies, Protozoan; D000953:Antigens, Protozoan