Abstract
BACKGROUND Dogs are the main peridomiciliary reservoir of Leishmania infantum thus the correct diagnosis of infection is essential for the control of the transmission and treatment as well. However, the diagnosis is based on serological assays that are not fully effective.OBJECTIVE We aimed to establish an effective serological assay for the diagnosis of L. infantum infected dogs using Leishmania-derived recombinant antigens.METHODS Leishmania derived rK39-, rK28-, rKR95-based enzyme-linked immunosorbent assay (ELISA) was standardized using symptomatic and asymptomatic L. infantum-infected dogs. Then 2,530 samples from inquiry in endemic areas for VL were evaluated and the results compared with recommended assays by the Brazilian Ministry of Health (MH algorithm). Further samples from a cohort of 30 dogs were searched.FINDINGS For rK39-, rK28- and rKR95-ELISA the sensitivity was around 97% and specificity 100%. The positivity of these three ELISA in the inquiry samples was 27-28%, around 10% higher than the assays currently in use. When cohort samples were searched, we observed likely false-negative results (> 65%) with supposedly negative samples that turned positive six months later with the assays in use (MH algorithm).MAIN CONCLUSIONS For the diagnosis of L. infantum-infected dogs, rK39-based ELISA showed better diagnostic performance than other assays in use in Brazil and worldwide.
Highlights
Dogs are the main peridomiciliary reservoir of Leishmania infantum the correct diagnosis of infection is essential for the control of the transmission and treatment as well
When the sera of 74 symptomatic dogs with positive parasitological examination were submitted to the Ministry of Health (MH) algorithm, the sensitivity was 93.2% and the specificity 100.0% with 66 samples from healthy dogs
The receiver operating characteristic (ROC) curve was constructed from the titers of positive samples and negative samples from healthy dogs, generating a sensitivity of 97.3% and specificity of 100.0% at a 1/640 cut-off point (Fig. 3)
Summary
Dogs are the main peridomiciliary reservoir of Leishmania infantum the correct diagnosis of infection is essential for the control of the transmission and treatment as well. The diagnosis is based on serological assays that are not fully effective
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