Phase II validation study of the rK39 ELISA prototype for the diagnosis of canine visceral leishmaniasis in Brazil

Abstract: Dogs are the main reservoirs in domestic transmission cycle of visceral leishmaniasis, and diagnosis is essential for effectiveness control measures recommended by Brazilian Ministry Health. We assessed diagnostic performance ELISA-Vetlisa/BIOCLIN prototype with serum samples from 200 dogs, triplicate, including symptomatic, oligosymptomatic, asymptomatic, healthy originated two distinct panels (A B) characterized parasitological tests as reference standard. In this study, kit showed a 99% sensitivity (95%CI: 94.5-100.0) 100% specificity 96.4-100.0). The did not vary significantly clinical status dogs. Considering final result classification (positive or negative), agreement between results repeated was almost perfect (kappa = 0.99; 95%CI: 0.98-1.00). promising option serological canine leishmaniasis Brazil.