High Performance of ELISA test using recombinant rLiNTPDase2 from Leishmania infantum: a Phase II diagnosis of Canine Visceral Leishmaniasis

dc.creatorSouza, Anna Cláudia Alves de
dc.creatorCastro, Raissa Barbosa de
dc.creatorSantos, Yaro Luciolo dos
dc.creatorPavione, Nancy da Rocha Torres
dc.creatorAgripino, Joice de Melo
dc.creatorBahia, Maria Terezinha
dc.creatorCoelho, George Luiz Lins Machado
dc.creatorSouza, Ronny Francisco de
dc.creatorOliveira, Leandro Licursi de
dc.creatorSouza, Celeste da Silva Freitas de
dc.creatorBressan, Gustavo Costa
dc.creatorVasconcellos, Raphael de Souza
dc.creatorAlmeida, Márcia Rogéria de
dc.creatorFietto, Juliana Lopes Rangel
dc.date2020-08-03T18:30:34Z
dc.date2020-08-03T18:30:34Z
dc.date2020
dc.date.accessioned2023-09-26T23:21:48Z
dc.date.available2023-09-26T23:21:48Z
dc.identifierSOUZA, Anna Cláudia Alves de et al. High Performance of ELISA test using recombinant rLiNTPDase2 from Leishmania infantum: a Phase II diagnosis of Canine Visceral Leishmaniasis. Acta Tropica, v. 209, 105535, p. 1-10, 2020.
dc.identifier0001-706X
dc.identifierhttps://www.arca.fiocruz.br/handle/icict/42512
dc.identifier10.1016/j.actatropica.2020.105535
dc.identifier1873-6254
dc.identifier.urihttps://repositorioslatinoamericanos.uchile.cl/handle/2250/8889753
dc.descriptionCanine visceral leishmaniasis (CVL) has been the theme of several studies given the importance of dog as natural reservoir of the pathogen Leishmania infantum in endemic regions and its role on dissemination of CVL and human visceral Lesihmaniasis (VL). The current immunodiagnosis of CVL has limitations concerning accuracy, specificity and sensitivity. Therefore, improvements are required. rLiNTPDase2 has been previously highlighted as a new recombinant antigen from L. infantum to the CVL diagnosis by ELISA assay (rLiNTPDase2-ELISA). In this study, we aimed to evaluate rLiNTPDase2-ELISA in a Phase II study with 651 dog sera samples, also comparing it with methodologies previously established and used in epidemiology surveillance in Brazil, an endemic country of CVL and VL. The rLiNTPDase2-ELISA using standard control sera showed high capability to distinguish between positive and negative sera, sensitivity of 92.6% and specificity of 88.5%. The test was reproductive and the kappa statistics judgement “substantial agreement”. rLiNTPDase2-ELISA does not show cross-reactivity with ehrlichiosis-reagent sera. However, we verified 15.3% of cross-reactivity with Chagas disease-reagent sera. The performance of rLiNTPDase2-ELISA was evaluated using sera samples from vaccinated dogs (Leish-Tec®). The results showed high agreement with parasitological and PCR results (sensitivity of 100.0% and specificity of 91.7%). Furthermore, we compared the performance of rLiNTPDase2-ELISA in CVL-reagent sera samples from endemic areas, which were previously diagnosed using other tests for CVL: immunofluorescent (IFI-LVC-BioManguinhos), IFI-LVC-Bio-Manguinhos coupled to ELISA (EIE-LVC-Bio-Manguinhos) and the Rapid Dual Path Platform® (TR-DPP®-Bio-Manguinhos) coupled to EIE-LVC-Bio-Manguinhos. rLiNTPDase2-ELISA showed high level of concordance with IFI-LVC-Bio-Manguinhos (88.6%) and with IFI-LVC-Bio-Manguinhos coupled to EIELVC-Bio-Manguinhos (82.9%) but not with TR-DPP® -Bio-Manguinhos coupled to EIE-LVC-Bio-Manguinhos (33.3%), which casts doubts on the effectiveness of this latest test. In addition, the rLiNTPDase2 antigen adsorbed in 96-well plate was stable enough to be used at least for three months. Taken together, our data confirmed, by Phase II study using hundreds samples, the good potential of rLiNTPDase2-ELISA to be used in the field as a new diagnostic assay for CVL.
dc.description2025-01-01
dc.formatapplication/pdf
dc.languageeng
dc.publisherElsevier 12 Months
dc.rightsrestricted access
dc.subjectLeishmaniose canina
dc.subjectRecombinante
dc.subjectAntígeno
dc.subjectELISA
dc.subjectrLiNTPDase2
dc.subjectRecombinant
dc.subjectAntigen
dc.subjectELISA
dc.subjectCanine Leishmaniasis
dc.titleHigh Performance of ELISA test using recombinant rLiNTPDase2 from Leishmania infantum: a Phase II diagnosis of Canine Visceral Leishmaniasis
dc.typeArticle


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