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BioMed Research International Volume 2019 ,2019-07-24
Development and Clinical Evaluation of Loop-Mediated Isothermal Amplification (LAMP) Assay for the Diagnosis of Human Visceral Leishmaniasis in Brazil
Research Article
Daniel Moreira de Avelar 1 Débora Moreira Carvalho 1 Ana Rabello 1
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DOI:10.1155/2019/8240784
Received 2019-03-07, accepted for publication 2019-06-18, Published 2019-06-18
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摘要

Visceral leishmaniasis (VL) is considered a major public health concern in Brazil and several regions of the world. A recent advance in the diagnosis of infectious diseases was the development of loop-mediated isothermal amplification (LAMP). The aim of this study was to develop and evaluate a new LAMP assay for detection of K26 antigen-coding gene of L. donovani complex. A total of 219 blood samples of immunocompetent patients, including 114 VL cases and 105 non-VL cases, were analyzed for the diagnosis of VL in the present study. Diagnostic accuracy was calculated against a combination of parasitological and/or serological tests as a reference standard. The results were compared to those of kDNA Leishmania-PCR. The detection limit for the K26-Lamp assay was 1fg L. infantum purified DNA and 100 parasites/mL within 60 min of amplification time with visual detection for turbidity. The assay was specific for L. donovani complex. Sensitivity, specificity, and accuracy were 98.2%, 98.1%, and 98.2%, respectively, for K26-LAMP and 100%, 100%, and 100%, respectively, for kDNA Leishmania-PCR. Excellent agreement was observed between K26-LAMP and kDNA Leishmania-PCR assays (K = 0.96). A highly sensitive and specific LAMP assay targeting K26 antigen-coding gene of L. donovani complex was developed for diagnosis in peripheral blood samples of VL patients.

授权许可

Copyright © 2019 Daniel Moreira de Avelar et al. 2019
This is an open access article distributed under the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.

通讯作者

Daniel Moreira de Avelar.Fundação Oswaldo Cruz, Instituto René Rachou, Pesquisa Clínica e Políticas Públicas em Doenças Infecciosas e Parasitárias, Belo Horizonte, MG, Brazil, fiocruz.br.daniel.avelar@fiocruz.br

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Daniel Moreira de Avelar,Débora Moreira Carvalho,Ana Rabello. Development and Clinical Evaluation of Loop-Mediated Isothermal Amplification (LAMP) Assay for the Diagnosis of Human Visceral Leishmaniasis in Brazil. BioMed Research International ,Vol.2019(2019)

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