Comparison of a rapid immunochromatographic assay with an immunofluorescent antibody test for detection of Leishmania infantum antibodies in dogs.

Background: Identification of Leishmania infantum-infected dogs is crucial for control of canine leishmaniosis. In particular, in areas where access to specialized laboratories is limited, the availability of reliable and rapid in-clinic serologic tests may support immediate diagnosis in suspected cases and permit detection of asymptomatic canine carriers of L infantum infection.

Objective: The purpose of the study was to validate the immunochromatographic test (ICT) Anigen Rapid Leishmania Ab Test kit for detection of L infantum antibodies in naturally exposed dogs in comparison with the immunofluorescence antibody test (IFAT).

Methods: Serum samples from 66 dogs, including 20 healthy control dogs and 46 dogs suspected or confirmed with canine leishmaniosis, were measured by both tests. Anti-Leishmania IgG titers ≥ 1:40 by IFAT were considered positive. Kappa statistic with a 95% CI was calculated to evaluate agreement between the 2 testing methods, and sensitivity, specificity, and positive and negative likelihood ratio were calculated.

Results: Anti-L infantum IgG antibodies were found in 35 of 66 samples using the IFAT test (titers 1:40-1:5120). Thirty-one out of 66 samples tested positive with the qualitative ICT. Four IFAT-positive (titers < 1:80) samples were ICT-negative. The Kappa value of 0.853 demonstrated very good agreement between the 2 tests.

Conclusion: The Anigen Rapid Leishmania Ab Test kit reliably identified canine sera with anti-L infantum IgG antibody titers ≥ 1:40. The ICT requires neither special preparation of the serum nor specialized equipment and can be stored at ambient temperature. The test is applicable as a field test because it is easy to use and provides rapid results.