Improving the reference standard for the diagnosis of canine visceral leishmaniasis: a challenge for current and future tests

BACKGROUND Studies aimed at validating canine visceral leishmaniasis diagnostic tests present heterogeneous results regarding test accuracy, partly due to divergences in reference standards used and different infection evolution periods in animals. OBJECTIVE This study aimed to evaluate the accur...

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Main Authors: Ana Izabel Passarella Teixeira, Debora Marcolino Silva, Tamires Vital, Nadjar Nitz, Bruna Caroline de Carvalho, Mariana Hecht, Diana Oliveira, Edward Oliveira, Ana Rabello, Gustavo Adolfo Sierra Romero
Format: Article
Language:English
Published: Fundação Oswaldo Cruz (FIOCRUZ) 2019-01-01
Series:Memorias do Instituto Oswaldo Cruz
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Online Access:http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0074-02762019000100307&lng=en&tlng=en
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author Ana Izabel Passarella Teixeira
Debora Marcolino Silva
Tamires Vital
Nadjar Nitz
Bruna Caroline de Carvalho
Mariana Hecht
Diana Oliveira
Edward Oliveira
Ana Rabello
Gustavo Adolfo Sierra Romero
author_facet Ana Izabel Passarella Teixeira
Debora Marcolino Silva
Tamires Vital
Nadjar Nitz
Bruna Caroline de Carvalho
Mariana Hecht
Diana Oliveira
Edward Oliveira
Ana Rabello
Gustavo Adolfo Sierra Romero
author_sort Ana Izabel Passarella Teixeira
collection DOAJ
description BACKGROUND Studies aimed at validating canine visceral leishmaniasis diagnostic tests present heterogeneous results regarding test accuracy, partly due to divergences in reference standards used and different infection evolution periods in animals. OBJECTIVE This study aimed to evaluate the accuracy of the rapid test-dual path platform (TR-DPP) (Biomanguinhos®), EIE-Leishmaniose-Visceral-Canina-Biomanguinhos (EIE-LVC) (Biomanguinhos®), enzyme-linked immunosorbent assay (ELISA) rK39 (in-house), and the direct agglutination test (DAT-Canis) against a reference standard comprising parasitological and molecular techniques. METHODS A phase II/III validation study was carried out in sample sera from 123 predominantly asymptomatic dogs living in an area endemic for visceral leishmaniasis. FINDINGS Sixty-nine (56.1%) animals were considered infected according to the reference standard. For each test, the sensitivity and specificity, respectively, were as follows: TR-DPP, 21.74% [confidence interval (CI)95% 13.64% to 32.82%] and 92.59% (CI95% 82.45% to 97.08%); EIE-LVC, 11.59% (CI95% 5.9% to 21.25%) and 90.74% (CI95% 80.09% to 95.98%); ELISA rK39, 37.68% (CI95% 27.18% to 49.48%) and 83.33% (CI95% 71.26% to 90.98%); and DAT-Canis, 18.84% (CI95% 11.35% to 29.61%) and 96.30% (CI95% 87.46% to 98.98%). CONCLUSION We concluded that improving the sensitivity of serum testing for diagnosing asymptomatic dogs must constitute a priority in the process of developing new diagnostic tests to be used in the visceral leishmaniasis control program in Brazil.
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spelling doaj.art-10b160cf7aa446ef9550cb3ac3b1ab672023-09-02T16:22:13ZengFundação Oswaldo Cruz (FIOCRUZ)Memorias do Instituto Oswaldo Cruz1678-80602019-01-01114010.1590/0074-02760180452S0074-02762019000100307Improving the reference standard for the diagnosis of canine visceral leishmaniasis: a challenge for current and future testsAna Izabel Passarella TeixeiraDebora Marcolino SilvaTamires VitalNadjar NitzBruna Caroline de CarvalhoMariana HechtDiana OliveiraEdward OliveiraAna RabelloGustavo Adolfo Sierra RomeroBACKGROUND Studies aimed at validating canine visceral leishmaniasis diagnostic tests present heterogeneous results regarding test accuracy, partly due to divergences in reference standards used and different infection evolution periods in animals. OBJECTIVE This study aimed to evaluate the accuracy of the rapid test-dual path platform (TR-DPP) (Biomanguinhos®), EIE-Leishmaniose-Visceral-Canina-Biomanguinhos (EIE-LVC) (Biomanguinhos®), enzyme-linked immunosorbent assay (ELISA) rK39 (in-house), and the direct agglutination test (DAT-Canis) against a reference standard comprising parasitological and molecular techniques. METHODS A phase II/III validation study was carried out in sample sera from 123 predominantly asymptomatic dogs living in an area endemic for visceral leishmaniasis. FINDINGS Sixty-nine (56.1%) animals were considered infected according to the reference standard. For each test, the sensitivity and specificity, respectively, were as follows: TR-DPP, 21.74% [confidence interval (CI)95% 13.64% to 32.82%] and 92.59% (CI95% 82.45% to 97.08%); EIE-LVC, 11.59% (CI95% 5.9% to 21.25%) and 90.74% (CI95% 80.09% to 95.98%); ELISA rK39, 37.68% (CI95% 27.18% to 49.48%) and 83.33% (CI95% 71.26% to 90.98%); and DAT-Canis, 18.84% (CI95% 11.35% to 29.61%) and 96.30% (CI95% 87.46% to 98.98%). CONCLUSION We concluded that improving the sensitivity of serum testing for diagnosing asymptomatic dogs must constitute a priority in the process of developing new diagnostic tests to be used in the visceral leishmaniasis control program in Brazil.http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0074-02762019000100307&lng=en&tlng=encanine visceral leishmaniasisdiagnostic testsserology
spellingShingle Ana Izabel Passarella Teixeira
Debora Marcolino Silva
Tamires Vital
Nadjar Nitz
Bruna Caroline de Carvalho
Mariana Hecht
Diana Oliveira
Edward Oliveira
Ana Rabello
Gustavo Adolfo Sierra Romero
Improving the reference standard for the diagnosis of canine visceral leishmaniasis: a challenge for current and future tests
Memorias do Instituto Oswaldo Cruz
canine visceral leishmaniasis
diagnostic tests
serology
title Improving the reference standard for the diagnosis of canine visceral leishmaniasis: a challenge for current and future tests
title_full Improving the reference standard for the diagnosis of canine visceral leishmaniasis: a challenge for current and future tests
title_fullStr Improving the reference standard for the diagnosis of canine visceral leishmaniasis: a challenge for current and future tests
title_full_unstemmed Improving the reference standard for the diagnosis of canine visceral leishmaniasis: a challenge for current and future tests
title_short Improving the reference standard for the diagnosis of canine visceral leishmaniasis: a challenge for current and future tests
title_sort improving the reference standard for the diagnosis of canine visceral leishmaniasis a challenge for current and future tests
topic canine visceral leishmaniasis
diagnostic tests
serology
url http://www.scielo.br/scielo.php?script=sci_arttext&pid=S0074-02762019000100307&lng=en&tlng=en
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