2026-07-22T20:11:00Zhttps://repisalud.isciii.es/rest/oai/requestoai:repisalud.isciii.es:20.500.12105/129972025-06-19T08:45:46Zcom_20.500.12105_2052com_20.500.12105_2051col_20.500.12105_19613
Repisalud
author
Hossain, Faria
author
Picado, Albert
author
Owen, Sophie I
author
Ghosh, Prakash
author
Chowdhury, Rajashree
author
Maruf, Shomik
author
Khan, Md Anik Ashfaq
author
Rashid, Md Utba
author
Nath, Rupen
author
Baker, James
author
Ghosh, Debashis
author
Adams, Emily R
author
Duthie, Malcolm S
author
Hossain, Md Sakhawat
author
Basher, Ariful
author
Nath, Proggananda
author
Aktar, Fatima
author
Cruz, Israel
author
Mondal, Dinesh
funder
Federal Ministry of Education & Research (Alemania)
funder
Wellcome Trust
funder
Government of the United Kingdom
funder
Government of Switzerland
funder
Government of Netherlands
2021-05-23T17:41:41Z
2021-05-23T17:41:41Z
2021
Front Cell Infect Microbiol . 2021 Apr 26;11:670759.
10.3389/fcimb.2021.670759
2235-2988
Frontiers in Cellular and Infection Microbiology
33981632
http://hdl.handle.net/20.500.12105/12997
With reduced prevalence of visceral leishmaniasis (VL) in the Indian subcontinent (ISC), direct and field deployable diagnostic tests are needed to implement an effective diagnostic and surveillance algorithm for post-elimination VL control. In this regard, here we investigated the diagnostic efficacies of a loop-mediated isothermal amplification (LAMP) assay (Loopamp™ Leishmania Detection Kit, Eiken Chemical CO., Ltd, Japan), a real-time quantitative PCR assay (qPCR) and the Leishmania antigen ELISA (CLIN-TECH, UK) with different sampling techniques and evaluated their prospect to incorporate into post-elimination VL control strategies. Eighty clinically and rK39 rapid diagnostic test confirmed VL cases and 80 endemic healthy controls were enrolled in the study. Peripheral blood and dried blood spots (DBS) were collected from all the participants at the time of diagnosis. DNA was extracted from whole blood (WB) and DBS via silica columns (QIAGEN) and boil & spin (B&S) methods and tested with qPCR and Loopamp. Urine was collected from all participants at the time of diagnosis and was directly subjected to the Leishmania antigen ELISA. 41 patients were followed up and urine samples were collected at day 30 and day 180 after treatment and ELISA was performed. The sensitivities of the Loopamp-WB(B&S) and Loopamp-WB(QIA) were 96.2% (95% CI 89·43-99·22) and 95% (95% CI 87·69-98·62) respectively. The sensitivity of Loopamp-DBS(QIA) was 85% (95% CI 75·26- 92·00). The sensitivities of the qPCR-WB(QIA) and qPCR-DBS(QIA) were 93.8% (95% CI 86·01-97·94) and 72.5% (95% CI 61·38-81·90) respectively. The specificity of all molecular assays was 100%. The sensitivity and specificity of the Leishmania antigen ELISA were 97.5% (95% CI 91·47-99·70) and 91.95% (95% CI 84·12-96·70) respectively. The Leishmania antigen ELISA depicted clinical cure at day 180 in all the followed-up cases. Efficacy and sustainability identify the Loopamp-WB(B&S) and the Leishmania antigen ELISA as promising and minimally invasive VL diagnostic tools to support VL diagnostic and surveillance activities respectively in the post-elimination era.
eng
LAMP
Diagnosis
Diagnostics for VL post-elimination era
Elimination
QPCR
Urine ELISA
Visceral leishmaniasis
Evaluation of Loopamp™ Leishmania Detection Kit and Leishmania Antigen ELISA for Post-Elimination Detection and Management of Visceral Leishmaniasis in Bangladesh
research article
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