Santos, Anna Raquel Ribeiro dosSerufo, Ângela VieiraFigueiredo, Maria MartaGodoi, Lara CarvalhoVitório, Jéssica GardoneMarcelino, Andreza PainAvelar, Daniel Moreira deRodrigues, Fernandes Tenório GomesCoelho, George Luiz Lins MachadoMedeiros, Fernanda Alvarenga CardosoJeronimo, Selma Maria BezerraOliveira, Edward José deNascimento, Frederico CrepaldiTeixeira, Santuza Maria RibeiroGazzinelli, Ricardo TostesNagem, Ronaldo Alves PintoFernandes, Ana Paula Salles Moura2019-04-222019-04-222019SANTOS, A. R. R. dos et al. Evaluation of three recombinant proteins for the development of ELISA and immunochromatographic tests for visceral leishmaniasis serodiagnosis. Memórias do Instituto Oswaldo Cruz, Rio de Janeiro, v. 114, p. 1-11, fev. 2019. Disponível em: <http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0074-02762019000100310&lng=en&nrm=iso&tlng=en>. Acesso em: 7 mar. 2019.0074-0276http://www.repositorio.ufop.br/handle/123456789/11099BACKGROUND Visceral Leishmaniasis (VL) is an infectious disease that is a significant cause of death among infants aged under 1 year and the elderly in Brazil. Serodiagnosis is a mainstay of VL elimination programs; however, it has significant limitations due to low accuracy. OBJECTIVE This study aimed to evaluate three recombinant Leishmania infantum proteins (rFc, rC9, and rA2) selected from previous proteomics and genomics analyses to develop enzyme-linked immunosorbent assay (ELISA) and immunochromatographic tests (ICT) for the serodiagnosis of human VL (HVL) and canine VL (CVL). METHODS A total of 186 human (70 L. infantum-infected symptomatic, 20 other disease-infected, and 96 healthy) and 185 canine (82 L. infantum-infected symptomatic, 27 L. infantum-infected asymptomatic, and 76 healthy) sera samples were used for antibody detection. FINDINGS Of the three proteins, rA2 (91.5% sensitivity and 87% specificity) and rC9 (95.7% sensitivity and 87.5% specificity) displayed the best performance in ELISA-HVL and ELISA-CVL, respectively. ICT-rA2 also displayed the best performance for HVL diagnosis (92.3% sensitivity and 88.0% specificity) and had high concordance with immunofluorescence antibody tests (IFAT), ELISA-rK39, IT-LEISH®, and ELISAEXT. ICT-rFc, ICT-rC9, and ICT-rA2 had sensitivities of 88.6%, 86.5%, and 87.0%, respectively, with specificity values of 84.0%, 92.0%, and 100%, respectively for CVL diagnosis. MAIN CONCLUSIONS The three antigens selected by us are promising candidates for VL diagnosis regardless of the test format, although the antigen combinations and test parameters may warrant further optimisation.en-USabertoDiagnosisEvaluation of three recombinant proteins for the development of ELISA and immunochromatographic tests for visceral leishmaniasis serodiagnosis.Artigo publicado em periodicoTodo o conteúdo do periódico Memórias do Instituto Oswaldo Cruz, exceto onde identificado, está licenciado sob uma licença Creative Commons 4.0 que permite copiar, distribuir e transmitir o trabalho em qualquer suporte ou formato desde que sejam citados o autor e o licenciante. Fonte: Memórias do Instituto Oswaldo Cruz <http://www.scielo.br/scielo.php/script_sci_serial/pid_0074-0276/lng_pt/nrm_iso>. Acesso em: 03 jan. 2017.