Improving the reference standard for the diagnosis of canine visceral leishmaniasis: a challenge for current and future tests
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. This study aimed to evaluate the accuracy of the rapid test-du...
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Published in | Memórias do Instituto Oswaldo Cruz Vol. 114; p. e180452 |
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Main Authors | , , , , , , , , , |
Format | Journal Article |
Language | English Portuguese |
Published |
Brazil
Instituto Oswaldo Cruz, Ministério da Saúde
01.01.2019
Fundação Oswaldo Cruz (FIOCRUZ) |
Subjects | |
Online Access | Get full text |
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Summary: | 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.
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.
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.
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%).
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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Bibliography: | ObjectType-Article-1 SourceType-Scholarly Journals-1 ObjectType-Feature-2 content type line 23 ObjectType-Undefined-3 GASR, AR and AIPT provided an intellectual framework for the preparation of this study; AIPT and DMS collected the biological samples, conducted the PCR, culture, and parasitology experiments; TV, NN, BCC and MH performed the qPCR experiments; DO and EO conducted the DAT and ELISA rk39 serological tests. All authors contributed to data analysis and drafting the manuscript, and all have read and approved the final version. |
ISSN: | 0074-0276 1678-8060 1678-8060 |
DOI: | 10.1590/0074-02760180452 |