Development of a Dipstick Assay for Detection of
            <i>Leishmania</i>
            -Specific Canine Antibodies

Schallig, Henk D. F. H.; Cardoso, Luı́s; Hommers, M; Kroon, Nel C. M.; Belling, Guus; Rodrigues, M.A.M.; Semião-Santos, Saul J.; Vetter, Hans

doi:10.1128/jcm.42.1.193-197.2004

Cited by 16 publications

(11 citation statements)

References 19 publications

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“…In contrast to the human results, dominance of anti-K39 response in canine VL seemed to be lower. This observation agrees with previous studies showing a dipstick test with parasite crude lysate had better sensitivity than K39 in dogs (Reithinger et al, 2002; Schallig et al, 2004). Using lysate antigen, however, is often problematic for reproducible specificity and manufacturability (Gomes et al, 2008).…”

Section: Discussionsupporting

confidence: 93%

Distinct antigen recognition pattern during zoonotic visceral leishmaniasis in humans and dogs

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Howard

Bhatia

et al. 2009

Veterinary Parasitology

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Leishmania infantum is a causative agent of endemic zoonotic visceral leishmaniasis (VL) in regions of South America and the Mediterranean. Dogs are the major reservoirs for Leishmania infantum in these regions, and control of disease in dogs could have a significant impact on human disease. Although dogs share many symptoms of VL with humans as a result of L. infantum infection, they also show some unique clinical manifestations, which are often a combination of visceral and cutaneous leishmaniasis, suggesting different mechanisms of disease development in dogs and humans. Here, we compare antibody responses of dogs and humans with VL to various defined leishmanial antigens. Parasite lysate and K39, the two most commonly used antigens for serodiagnosis of VL, detected the highest levels of antibodies in both humans and dogs with VL, whereas the recognition patterns of these antigens were distinct between the hosts. Among other defined antigens tested, LmSTI1 and CPB detected higher levels of antibodies in dogs and humans, respectively. These results indicate there is a difference between humans and dogs in antigen recognition patterns during VL; we infer that different strategies may need to be used in development of vaccines and diagnostics for humans and for dogs. In addition, we show a correlation between antibody titers to several antigens and severity of clinical symptoms during canine VL.

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Section: Discussionsupporting

confidence: 93%

Distinct antigen recognition pattern during zoonotic visceral leishmaniasis in humans and dogs

Goto

Howard

Bhatia

et al. 2009

Veterinary Parasitology

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“…The only serological tests that had a specificity of 100% were the Leiscan ® , ID Screen ® and Speed Leish K ® , whilst other tests studied showed some cross-reactions with E. canis , A. phagocytophilum , R. conorii and T. gondii . This cross-reactivity phenomenon against other pathogens such as E. canis , Babesia canis , T. gondii , Neospora caninum and Hepatozoon canis has been sporadically described in other studies [19,29,30]. Cross-reactivity with L. infantum is more common in infection of dogs with other species of Leishmania or with other protozoans such as Trypanosoma cruzi, which are prevalent in America and not in Europe [31,32].…”

Section: Discussionmentioning

confidence: 85%

Serological diagnosis of canine leishmaniosis: comparison of three commercial ELISA tests (Leiscan®, ID Screen® and Leishmania 96®), a rapid test (Speed Leish K®) and an in-house IFAT

et al. 2014

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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.

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“…The use of multiple defined antigens in ELISA has been shown to increase sensitivity, with the relative sensitivity of different antigens varying between dogs [39], [40], [45]–[47]. Thus the development of RDTs using multiple defined antigens, or crude antigens, may increase sensitivity [48], [49]. Nonetheless, recent tests of a RDT incorporating both rK26 and rK39 reported low sensitivity (47%) to detect asymptomatic canine infections [49].…”

Section: Discussionmentioning

confidence: 99%

Evaluation of rK39 Rapid Diagnostic Tests for Canine Visceral Leishmaniasis: Longitudinal Study and Meta-Analysis

et al. 2013

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BackgroundThere is a need for sensitive and specific rapid diagnostic tests (RDT) for canine visceral leishmaniasis. The aims of this study were to evaluate the diagnostic performance of immunochromatographic dipstick RDTs using rK39 antigen for canine visceral leishmaniasis by (i) investigating the sensitivity of RDTs to detect infection, disease and infectiousness in a longitudinal cohort study of natural infection in Brazil, and (ii) using meta-analysis to estimate the sensitivity and specificity of RDTs from published studies.MethodologyWe used a rK39 RDT (Kalazar Detect Canine Rapid Test; Inbios) to test sera collected from 54 sentinel dogs exposed to natural infection in an endemic area of Brazil. Dogs were sampled bimonthly for up to 27 months, and rK39 results compared to those of crude antigen ELISA, PCR, clinical status and infectiousness to sandflies. We then searched MEDLINE and Web of Knowledge (1993–2011) for original studies evaluating the performance of rK39 RDTs in dogs. Meta-analysis of sensitivity and specificity was performed using bivariate mixed effects models.Principal FindingsThe sensitivity of the rK39 RDT in Brazil to detect infection, disease and infectiousness was 46%, 77% and 78% respectively. Sensitivity increased with time since infection, antibody titre, parasite load, clinical score and infectiousness. Sixteen studies met the inclusion criteria for meta-analysis. The combined sensitivity of rK39 RDTs was 86.7% (95% CI: 76.9–92.8%) to detect clinical disease and 59.3% (37.9–77.6%) to detect infection. Combined specificity was 98.7% (89.5–99.9%). Both sensitivity and specificity varied considerably between studies.ConclusionThe diagnostic performance of rK39 RDTs is reasonable for confirmation of infection in suspected clinical cases, but the sensitivity to detect infected dogs is too low for large-scale epidemiological studies and operational control programmes.

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Development of a Dipstick Assay for Detection of Leishmania -Specific Canine Antibodies

Cited by 16 publications

References 19 publications

Distinct antigen recognition pattern during zoonotic visceral leishmaniasis in humans and dogs

Distinct antigen recognition pattern during zoonotic visceral leishmaniasis in humans and dogs

Serological diagnosis of canine leishmaniosis: comparison of three commercial ELISA tests (Leiscan®, ID Screen® and Leishmania 96®), a rapid test (Speed Leish K®) and an in-house IFAT

Evaluation of rK39 Rapid Diagnostic Tests for Canine Visceral Leishmaniasis: Longitudinal Study and Meta-Analysis

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