Recombinant K39 dipstick immunochromatographic test: a new tool for the serodiagnosis of canine leishmaniasis.

The spread of human leishmaniasis has prompted the scientific community to study dogs as reservoirs for Leishmania infantum. Canine leishmaniasis (CanL) is widespread in the Mediterranean area with a prevalence of up to 50%. The first step toward controlling the disease is to monitor its distribution, mainly in stray dogs. The validity of a recombinant K39 (rK39) dipstick test, commercially available for the serodiagnosis of human leishmaniasis, was evaluated using sera from 165 dogs selected on the basis of positive or negative lymph node smears at parasitological examination. The results were compared with the indirect fluorescent antibody test (IFAT) (cutoff 1:80). Sera from a group of dogs with other diagnosed diseases but negative for leishmaniasis were also tested to evaluate any cross-reactivity. Various procedures were used for testing whole blood samples. The relative specificity of the rK39 dipstick and IFAT was 100% (97 of 97) and 98.97% (96 of 97), whereas the relative sensitivity was 97.06% (66 of 68) and 98.53% (67 of 68), respectively. The results of the dipstick and IFAT corresponded except for 2 sera (k = 0.987). This data confirm the usefulness of rK39 antigen for diagnosing CanL both in symptomatic and asymptomatic dogs. The rK39 dipstick proved to be a rapid, sensitive, and specific test that may be very useful in the field for large-scale screening and also in veterinary practice, requiring minimal equipment and operator expertise.