Application of a recombinant protein for the serological diagnosis of canine leishmaniasis

Boarino, Alice; Bollo, E.; Prunotto, L.; Canale, L.; Uslenghi, Federica; Poletti, Paula

doi:10.1016/j.cimid.2007.09.002

Cited by 5 publications

(8 citation statements)

References 13 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…The Leishmania 96 ® has also been evaluated in other studies [27]. Both sensitivity (88.9% versus 92.5% of this study) and specificity (78.2% versus at 89.6% in the present study) are mildly different with better diagnostic performance in the present study.…”

Section: Discussionsupporting

confidence: 50%

“…The absence of a diagnostic reference or gold standard results in the combination of one [27], two [33] or more diagnostic tests [29] used as “gold standard” in several studies from which new techniques can be compared. A problem associated with this lack of “gold standard” is that a standardization of results is not possible, which means that comparison of results between studies is difficult.…”

Section: Discussionmentioning

confidence: 99%

See 1 more Smart Citation

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

View full text Add to dashboard Cite

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.

show abstract

Section: Discussionsupporting

confidence: 50%

Section: Discussionmentioning

confidence: 99%

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

View full text Add to dashboard Cite

show abstract

“…So, with a 96% Se and a 98% Sp, the indirect fluorescent antibody test (IFAT) is one of the most suitable diagnostic tests. Despite the fact that IFAT is not a perfect test, it is frequently used as a reference test for the relative validation of new diagnostic methods [ 27 – 32 ] and to estimate the true CanL prevalence [ 33 – 35 ]. To assess the reliability of a new test in comparison with IFAT, the kappa coefficient is often utilized (e.g.…”

Section: Introductionmentioning

confidence: 99%

“…To assess the reliability of a new test in comparison with IFAT, the kappa coefficient is often utilized (e.g. [ 30 , 32 , 36 – 37 ]). However, a limitation of the kappa test is that it is affected by the prevalence of the condition under observation [ 38 ] and, thus, it is possible that despite a high concordance between two tests, the kappa coefficient may paradoxically be low.…”

Section: Introductionmentioning

confidence: 99%

Evaluation of Immunofluorescence Antibody Test Used for the Diagnosis of Canine Leishmaniasis in the Mediterranean Basin: A Systematic Review and Meta-Analysis

et al. 2016

View full text Add to dashboard Cite

With an expected sensitivity (Se) of 96% and specificity (Sp) of 98%, the immunofluorescence antibody test (IFAT) is frequently used as a reference test to validate new diagnostic methods and estimate the canine leihmaniasis (CanL) true prevalence in the Mediterranean basin. To review the diagnostic accuracy of IFAT to diagnose CanL in this area with reference to its Se and Sp and elucidate the potential causes of their variations, a systematic review was conducted (31 studies for the 26-year period). Three IFAT validation methods stood out: the classical contingency table method, methods based on statistical models and those based on experimental studies. A variation in the IFAT Se and Sp values and cut-off values was observed. For the classical validation method based on a meta-analysis, the Se of IFAT was estimated in this area as 89.86% and 31.25% in symptomatic and asymptomatic dogs, respectively. The Sp of IFAT was estimated in non-endemic and endemic areas as 98.12% and 96.57%, respectively. IFAT can be considered as a good standard test in non-endemic areas for CanL, but its accuracy declines in endemic areas due to the complexity of the disease. Indeed, the accuracy of IFAT is due to the negative results obtained in non-infected dogs from non-endemic areas and to the positive results obtained in sera of symptomatic dogs living in endemic areas. But IFAT results are not unequivocal when it comes to determining CanL infection on asymptomatic dogs living in endemic areas. Statistical methods might be a solution to overcome the lack of gold standard, to better categorize groups of animals investigated, to assess optimal cut-off values and to allow a better estimate of the true prevalence aiming information on preventive/control measures for CanL.

show abstract

“…According to Kar (1995) and Boarino (2008), the sensitivity and specificity of serological diagnostic methods depend on the type and purity of the antigen used [15], [16]. The tests currently available within the public health laboratory network in Brazil are produced by Bio-Manguinhos®, Fundação Oswaldo Cruz, Ministry of Health, and use L. major as antigen.…”

Section: Introductionmentioning

confidence: 99%

Validity and Reliability of Enzyme Immunoassays Using Leishmania major or L. infantum Antigens for the Diagnosis of Canine Visceral Leishmaniasis in Brazil

Arruda

Figueiredo²,

Cardoso³

et al. 2013

PLoS ONE

View full text Add to dashboard Cite

BackgroundAmerican visceral leishmaniasis is caused by the protozoan Leishmania infantum. Dogs are the main reservoirs in the domestic transmission cycle. The limited accuracy of diagnostic tests for canine leishmaniasis may contribute to the lack of impact of control measures recommended by the Brazilian Ministry of Health. The objective of this study was to estimate the accuracy of two enzyme-linked immunosorbent assays employing L. major or L. infantum antigens and their reliability between three laboratories of different levels of complexity.MethodsA validation study of ELISA techniques using L. major or L. infantum antigens was conducted. Direct visualization of the parasite in hematoxylin/eosin-stained histopathological sections, immunohistochemistry, and isolation of the parasite in culture.were used as gold standard. An animal that was positive in at least one of the tests was defined as infected with L. infantum. Serum samples collected from 1,425 dogs were analyzed. Samples were separated in three aliquots and tested in three different laboratories. Sensitivity, specificity and the area under de ROC curve were calculated and the reliability was evaluated between the participant laboratories.ResultsThe sensitivity was 91.8% and 89.8% for the L. major and L. infantum assays, respectively. The specificity was 83.75% and 82.7% for the L. major and L. infantum assays, respectively. The area under de ROC curve was 0.920 and 0.898 for L. major and L. infantum, respectively. The mean intraclass correlation coefficients between laboratories ranged from 0.890 to 0.948 when L. major was used as antigen, and from 0.818 to 0.879 when L. infantum was used.InterpretationELISA tests using L. major or L. infantum antigens have similar accuracy and reliability. Our results do not support the substitution of the L. major antigen of the ELISA test currently used for the diagnosis of canine visceral leishmaniasis in Brazil.

show abstract

Application of a recombinant protein for the serological diagnosis of canine leishmaniasis

Cited by 5 publications

References 13 publications

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

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 Immunofluorescence Antibody Test Used for the Diagnosis of Canine Leishmaniasis in the Mediterranean Basin: A Systematic Review and Meta-Analysis

Validity and Reliability of Enzyme Immunoassays Using Leishmania major or L. infantum Antigens for the Diagnosis of Canine Visceral Leishmaniasis in Brazil

Contact Info

Product

Resources

About