Development and evaluation of a novel LAMP assay for the diagnosis of Cutaneous and Visceral Leishmaniasis.

Adams, Emily ORCID: https://orcid.org/0000-0002-0816-2835, Schoone, Gerard, Versteeg, Inge, Gomez, Maria Adelaida, Diro, Ermias, Mori, Yasuyoshi, Perlee, Desiree, Downing, Tim, Saravia, Nancy, Assaye, Ashenafi, Hailu, Asrat, Albertini, Audrey, Ndung'u, Joseph Mathu and Schallig, Henk (2018) 'Development and evaluation of a novel LAMP assay for the diagnosis of Cutaneous and Visceral Leishmaniasis.'. Journal of Clinical Microbiology, Vol 56, Issue 7, e00386-18.

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Abstract

A novel LAMP assay was developed for diagnosis of Cutaneous and Visceral Leishmaniasis (CL & VL) which can be used in near-patient settings. Primers were designed on the 18S rDNA and the conserved region of minicircle kDNA selected on the basis of high copy number. LAMP assays were evaluated for CL in a prospective cohort trial of 105 patients in South-West Colombia. Lesion swab samples from CL suspects were collected and tested using LAMP and compared to a composite reference of microscopy AND/OR culture to calculate diagnostic accuracy. LAMP assays were tested on 50 VL suspected patients from Ethiopia, including whole blood, peripheral blood mononuclear cells, and buffy coat. Diagnostic accuracy was calculated against a reference standard of microscopy of splenic or bone marrow aspirates. To calculate analytical specificity 100 clinical samples and isolates with fever causing pathogens including malaria, arboviruses and bacterial infections were tested. The LAMP assay had a sensitivity of 95% (95% CI: 87.2% - 98.5 %) and a specificity of 86% (95% CI: 67.3% -95.9 %) for the diagnosis of CL. On VL suspects the sensitivity was 92% (95% CI: 74.9 - 99.1%) and specificity of 100% (95% CI: 85.8-100%) in whole blood. For CL, LAMP is a sensitive tool for diagnosis and requires less equipment, time and expertise than alternative CL diagnostics. For VL, LAMP is sensitive using a minimally invasive sample as compared to the gold standard. The analytical specificity was 100%. [Abstract copyright: Copyright © 2018 Adams et al.]

Item Type:	Article
Subjects:	QV Pharmacology > Drug Standardization. Pharmacognosy. Medicinal Plants > QV 771 Standardization and evaluation of drugs QW Microbiology and Immunology > Antigens and Antibodies. Toxins and Antitoxins > QW 575 Antibodies WC Communicable Diseases > WC 20 Research (General) WC Communicable Diseases > Tropical and Parasitic Diseases > WC 715 Visceral leishmaniasis
Faculty: Department:	Biological Sciences > Department of Tropical Disease Biology
Digital Object Identifer (DOI):	https://doi.org/10.1128/JCM.00386-18
SWORD Depositor:	JISC Pubrouter
Depositing User:	Stacy Murtagh
Date Deposited:	11 May 2018 14:41
Last Modified:	20 Jul 2018 11:04
URI:	https://archive.lstmed.ac.uk/id/eprint/8577

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