Validation of an immunochromatographic assay kit based on colored latex particles for the identification of the canine visceral leishmaniasis

Visceral leishmaniasis is a zoonotic infectious disease with a severe impact on humans and animals. Infection is transmitted by phlebotomine sand flies. The dogs are main reservoir for human infection. A rapid and accurate diagnosis of canine visceral leishmaniasis is essential for an efficient surveillance program. The aim of this study was to assess the performance of a rapid immunochromatographic strip test based on functionalized colored particles and a new recombinant antigenic protein, as a visual “in situ” method for the diagnosis of canine visceral leishmaniasis. The results were evaluated using an in-house ELISA assay with the same antigen. Both tests produced concordant results and the immunochromatographic strip test showed good diagnostic sensitivity (98%) and specificity (95%). Finally, meta-analysis was used to compare the sensitivity and specificity of the here developed test with the results of commercial immunochromatographic strip tests obtained from literature. [Display omitted] •A visual assay for the diagnosis of Canine Visceral Leishmaniasis was developed.•The reagent is based on functionalized colored particles and a recombinant antigenic.•The strip test showed good diagnostic sensitivity and specificity.•The result can be read after 10 min “in situ” and it is easy to implement.•The immunochromatographic test may be a rapid and inexpensive diagnostic strategy.