Comparison of ELISA and IFAT for Leishmania infantum by European and Middle Eastern diagnostic laboratories

Abstract Background Visceral leishmaniosis (VL) is the most severe form of human leishmaniosis, with an estimated 95% case fatality if left untreated. Dogs act as peridomestic reservoir hosts for the protozoan parasite Leishmania infantum, a causative agent for human leishmaniosis, endemic throughou...

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Main Authors: Kurayi G. Mahachi, Marie Ozanne, Patrick Bourdeau, Juliana Sarquis, Eric Kontowicz, Laia Solano-Gallego, Luis Cardoso, Gaetano Oliva, Gad Baneth, Maria Grazia Pennisi, Angela M. Toepp, Guadalupe Miró, Margaret Carrel, Christine A. Petersen
Format: Article
Language:English
Published: BMC 2024-12-01
Series:Parasites & Vectors
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Online Access:https://doi.org/10.1186/s13071-024-06631-9
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author Kurayi G. Mahachi
Marie Ozanne
Patrick Bourdeau
Juliana Sarquis
Eric Kontowicz
Laia Solano-Gallego
Luis Cardoso
Gaetano Oliva
Gad Baneth
Maria Grazia Pennisi
Angela M. Toepp
Guadalupe Miró
Margaret Carrel
Christine A. Petersen
author_facet Kurayi G. Mahachi
Marie Ozanne
Patrick Bourdeau
Juliana Sarquis
Eric Kontowicz
Laia Solano-Gallego
Luis Cardoso
Gaetano Oliva
Gad Baneth
Maria Grazia Pennisi
Angela M. Toepp
Guadalupe Miró
Margaret Carrel
Christine A. Petersen
author_sort Kurayi G. Mahachi
collection DOAJ
description Abstract Background Visceral leishmaniosis (VL) is the most severe form of human leishmaniosis, with an estimated 95% case fatality if left untreated. Dogs act as peridomestic reservoir hosts for the protozoan parasite Leishmania infantum, a causative agent for human leishmaniosis, endemic throughout the Mediterranean basin. To assure consistent and accurate surveillance of canine infection and prevent transmission to people, consistent diagnosis of canine L. infantum infection across this region is essential for protecting both human and animal health. Our goal was to compare the accuracy, sensitivity and specificity of enzyme-linked immunosorbent assays (ELISA) and immunofluorescence antibody tests (IFAT), performed at seven academic veterinary diagnostic centres across southern Europe and Israel. Methods We performed a known sample “ring” trial to compare L. infantum quantitative serological tests. Two hundred seventy-two (n = 272) canine serum samples of known serological status were chosen from these sites, representative of the region. In-house or commercial ELISA and IFAT were performed according to each laboratory’s specifications. Latent Class Analysis (LCA) was used to determine sensitivity and specificity of each test. True and false positives were calculated to determine the probability of identifying samples. Results Sensitivity and specificity for ELISA ranged from 95 to 99% and 92% to 97%, respectively, with moderate variability from one site. Sensitivity and specificity for IFAT ranged from 89 to 99% and 83% to 94%, respectively, with increased variability compared to ELISA. Overall test agreement was 78% with a pair-wise agreement between 65 and 89%. Conclusions All sites demonstrated substantial comparative diagnostic accuracy, with good agreement based on known seropositive and seronegative samples. Studies and interventional trials that use these tests will remain valid because of high diagnostic agreement between sites. Graphical Abstract
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spelling doaj-art-9831c6e71fbc412a8cfcf36e073b342b2025-08-20T01:48:08ZengBMCParasites & Vectors1756-33052024-12-0117111110.1186/s13071-024-06631-9Comparison of ELISA and IFAT for Leishmania infantum by European and Middle Eastern diagnostic laboratoriesKurayi G. Mahachi0Marie Ozanne1Patrick Bourdeau2Juliana Sarquis3Eric Kontowicz4Laia Solano-Gallego5Luis Cardoso6Gaetano Oliva7Gad Baneth8Maria Grazia Pennisi9Angela M. Toepp10Guadalupe Miró11Margaret Carrel12Christine A. Petersen13College of Public Health, University of IowaDepartment of Mathematics and Statistics, Mount Holyoke CollegeÉcolecole Nationale Vétérinaire, Agroalimentaire et de l’Alimentation, Nantes-Atlantique (ONIRIS)Animal Health Department, Veterinary Faculty, Universidad Complutense de MadridCollege of Public Health, University of IowaLeishVet Association, Veterinary Faculty, Universidad Complutense de MadridLeishVet Association, Veterinary Faculty, Universidad Complutense de MadridLeishVet Association, Veterinary Faculty, Universidad Complutense de MadridLeishVet Association, Veterinary Faculty, Universidad Complutense de MadridLeishVet Association, Veterinary Faculty, Universidad Complutense de MadridSentara Healthcare, Eastern Virginia Medical SchoolLeishVet Association, Veterinary Faculty, Universidad Complutense de MadridCollege of Public Health, University of IowaCollege of Public Health, University of IowaAbstract Background Visceral leishmaniosis (VL) is the most severe form of human leishmaniosis, with an estimated 95% case fatality if left untreated. Dogs act as peridomestic reservoir hosts for the protozoan parasite Leishmania infantum, a causative agent for human leishmaniosis, endemic throughout the Mediterranean basin. To assure consistent and accurate surveillance of canine infection and prevent transmission to people, consistent diagnosis of canine L. infantum infection across this region is essential for protecting both human and animal health. Our goal was to compare the accuracy, sensitivity and specificity of enzyme-linked immunosorbent assays (ELISA) and immunofluorescence antibody tests (IFAT), performed at seven academic veterinary diagnostic centres across southern Europe and Israel. Methods We performed a known sample “ring” trial to compare L. infantum quantitative serological tests. Two hundred seventy-two (n = 272) canine serum samples of known serological status were chosen from these sites, representative of the region. In-house or commercial ELISA and IFAT were performed according to each laboratory’s specifications. Latent Class Analysis (LCA) was used to determine sensitivity and specificity of each test. True and false positives were calculated to determine the probability of identifying samples. Results Sensitivity and specificity for ELISA ranged from 95 to 99% and 92% to 97%, respectively, with moderate variability from one site. Sensitivity and specificity for IFAT ranged from 89 to 99% and 83% to 94%, respectively, with increased variability compared to ELISA. Overall test agreement was 78% with a pair-wise agreement between 65 and 89%. Conclusions All sites demonstrated substantial comparative diagnostic accuracy, with good agreement based on known seropositive and seronegative samples. Studies and interventional trials that use these tests will remain valid because of high diagnostic agreement between sites. Graphical Abstracthttps://doi.org/10.1186/s13071-024-06631-9DogsEnzyme-linked immunosorbent assayEpidemiologyImmunofluorescence antibody testLatent Class AnalysisLeishmania
spellingShingle Kurayi G. Mahachi
Marie Ozanne
Patrick Bourdeau
Juliana Sarquis
Eric Kontowicz
Laia Solano-Gallego
Luis Cardoso
Gaetano Oliva
Gad Baneth
Maria Grazia Pennisi
Angela M. Toepp
Guadalupe Miró
Margaret Carrel
Christine A. Petersen
Comparison of ELISA and IFAT for Leishmania infantum by European and Middle Eastern diagnostic laboratories
Parasites & Vectors
Dogs
Enzyme-linked immunosorbent assay
Epidemiology
Immunofluorescence antibody test
Latent Class Analysis
Leishmania
title Comparison of ELISA and IFAT for Leishmania infantum by European and Middle Eastern diagnostic laboratories
title_full Comparison of ELISA and IFAT for Leishmania infantum by European and Middle Eastern diagnostic laboratories
title_fullStr Comparison of ELISA and IFAT for Leishmania infantum by European and Middle Eastern diagnostic laboratories
title_full_unstemmed Comparison of ELISA and IFAT for Leishmania infantum by European and Middle Eastern diagnostic laboratories
title_short Comparison of ELISA and IFAT for Leishmania infantum by European and Middle Eastern diagnostic laboratories
title_sort comparison of elisa and ifat for leishmania infantum by european and middle eastern diagnostic laboratories
topic Dogs
Enzyme-linked immunosorbent assay
Epidemiology
Immunofluorescence antibody test
Latent Class Analysis
Leishmania
url https://doi.org/10.1186/s13071-024-06631-9
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