Abstract
BackgroundSpeed Leish K® is used as a serological screening test for Leishmania infection prior to vaccination. Limited comparative serological studies with Speed Leish K® have been performed. The aim of this study was to evaluate the diagnostic performance of four commercially available serologic tests including ELISAs (Leiscan®, ID Screen® and Leishmania 96®), a rapid test (Speed Leish K®) and an in-house IFAT for the detection of specific antibodies against Leishmania infantum antigen in dogs in different states of infection.MethodsSick infected dogs (n = 36), healthy infected dogs (n = 18), L. infantum seropositive dogs with low to high levels of antibodies (n = 53), dogs seropositive to other pathogens (to evaluate cross reaction) (n = 14) and uninfected dogs from a non-endemic area (n = 50) and from an endemic area (n = 32) were analysed by the serological methods mentioned above.ResultsThe sensitivity was as follows: ID Screen® (0.953), Leiscan® and Leishmania 96® (0.925), IFAT (0.869) and Speed Leish K® (0.636). The maximum specificity (1.000) was attained for all diagnostic tests except the Leishmania 96® (0.896) and IFAT (0.917). The accuracy was as follows: ID Screen® (0.975), Leiscan® (0.961), Leishmania 96® (0.911), IFAT (0.892) and Speed Leish K® (0.808). In relation to the area under the ROC curve (AUC-ROC), the maximum value was attained with the ID Screen® (0.993) closely followed by Leiscan® (0.990), then, Leishmania 96® (0.962), IFAT (0.926) and Speed Leish K® (0.818). For the Kappa index, the best result was obtained by the ID Screen® (0.951) followed by Leiscan® (0.921), Leishmania 96® (0.822), IFAT (0.783) and Speed Leish K® (0.622). Statistically significant differences were found between the AUC-ROC of quantitative serological tests and the only qualitative rapid test evaluated. There were also statistically significant differences between AUC-ROC of the ELISAs (ID Screen® and Leiscan®) and IFAT.ConclusionsLeiscan® and ID Screen® had superior diagnostic performance measures than IFAT and all quantitative serological tests were superior when compared to Speed Leish K®. Thus, Speed Leish K® may be considered a less valuable screening test prior to vaccination as it may result in vaccination of seropositive dogs and in some cases seropositive sick dogs.
Highlights
Speed Leish K® is used as a serological screening test for Leishmania infection prior to vaccination
Using the Youden index to measure test efficiency, the highest efficiency was obtained by the ID Screen® (0.953), Leiscan® (0.925), Leishmania 96® (0.821), indirect fluorescent antibody test (IFAT) (0.786) and, the Speed Leish K® (0.636)
Apart from the Universitat Autònoma de Barcelona (UAB) in house enzyme-linked immunosorbent assay (ELISA) test, IFAT was the only one test able to detect all the subjects belonging to the group of clinically sick infected dogs (36/36) and almost all the ones belonging to the group of clinically healthy infected dogs (17/18)
Summary
Speed Leish K® is used as a serological screening test for Leishmania infection prior to vaccination. Canine leishmaniosis (CanL) is a vector-borne zoonotic disease caused by Leishmania infantum, endemic in more than 70 countries in the world. It is present in regions of southern Europe, Africa, Asia, South and Central America [1]. Clinical staging of CanL includes four stages of severity of illness based on clinical signs, clinicopathological abnormalities and serology. For these reasons, diagnosis of this parasitic infection and its clinical manifestations can be complex [2,3]
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