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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<jats:italic>L. donovani<\/jats:italic>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<jats:italic>Leishmania-<\/jats:italic>PCR. The detection limit for the K26-Lamp assay was 1fg<jats:italic>L. infantum<\/jats:italic>purified DNA and 100 parasites\/mL within 60 min of amplification time with visual detection for turbidity. The assay was specific for<jats:italic>L. donovani<\/jats:italic>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<jats:italic>Leishmania<\/jats:italic>-PCR. Excellent agreement was observed between K26-LAMP and kDNA<jats:italic>Leishmania-<\/jats:italic>PCR assays (K = 0.96). A highly sensitive and specific LAMP assay targeting K26 antigen-coding gene of<jats:italic>L. donovani<\/jats:italic>complex was developed for diagnosis in peripheral blood samples of VL patients.<\/jats:p>","DOI":"10.1155\/2019\/8240784","type":"journal-article","created":{"date-parts":[[2019,7,24]],"date-time":"2019-07-24T23:31:15Z","timestamp":1564011075000},"page":"1-7","source":"Crossref","is-referenced-by-count":14,"title":["Development and Clinical Evaluation of Loop-Mediated Isothermal Amplification (LAMP) Assay for the Diagnosis of Human Visceral Leishmaniasis in Brazil"],"prefix":"10.1155","volume":"2019","author":[{"ORCID":"https:\/\/orcid.org\/0000-0001-7907-7913","authenticated-orcid":true,"given":"Daniel Moreira de","family":"Avelar","sequence":"first","affiliation":[{"name":"Funda\u00e7\u00e3o Oswaldo Cruz, Instituto Ren\u00e9 Rachou, Pesquisa Cl\u00ednica e Pol\u00edticas P\u00fablicas em Doen\u00e7as Infecciosas e Parasit\u00e1rias, Belo Horizonte, MG, 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