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Evaluation of Loopamp™ Leishmania Detection Kit and Leishmania Antigen ELISA for Post-Elimination Detection and Management of Visceral Leishmaniasis in Bangladesh

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 effica...

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Autores principales: Hossain, Faria, Picado, Albert, Owen, Sophie I., Ghosh, Prakash, Chowdhury, Rajashree, Maruf, Shomik, Khan, Md. Anik Ashfaq, Rashid, Md. Utba, Nath, Rupen, Baker, James, Ghosh, Debashis, Adams, Emily R., Duthie, Malcolm S., Hossain, Md. Sakhawat, Basher, Ariful, Nath, Proggananda, Aktar, Fatima, Cruz, Israel, Mondal, Dinesh
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Frontiers Media S.A. 2021
Materias:
Acceso en línea:https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8108992/
https://www.ncbi.nlm.nih.gov/pubmed/33981632
http://dx.doi.org/10.3389/fcimb.2021.670759
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author Hossain, Faria
Picado, Albert
Owen, Sophie I.
Ghosh, Prakash
Chowdhury, Rajashree
Maruf, Shomik
Khan, Md. Anik Ashfaq
Rashid, Md. Utba
Nath, Rupen
Baker, James
Ghosh, Debashis
Adams, Emily R.
Duthie, Malcolm S.
Hossain, Md. Sakhawat
Basher, Ariful
Nath, Proggananda
Aktar, Fatima
Cruz, Israel
Mondal, Dinesh
author_facet Hossain, Faria
Picado, Albert
Owen, Sophie I.
Ghosh, Prakash
Chowdhury, Rajashree
Maruf, Shomik
Khan, Md. Anik Ashfaq
Rashid, Md. Utba
Nath, Rupen
Baker, James
Ghosh, Debashis
Adams, Emily R.
Duthie, Malcolm S.
Hossain, Md. Sakhawat
Basher, Ariful
Nath, Proggananda
Aktar, Fatima
Cruz, Israel
Mondal, Dinesh
author_sort Hossain, Faria
collection PubMed
description 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.
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spelling pubmed-81089922021-05-11 Evaluation of Loopamp™ Leishmania Detection Kit and Leishmania Antigen ELISA for Post-Elimination Detection and Management of Visceral Leishmaniasis in Bangladesh Hossain, Faria Picado, Albert Owen, Sophie I. Ghosh, Prakash Chowdhury, Rajashree Maruf, Shomik Khan, Md. Anik Ashfaq Rashid, Md. Utba Nath, Rupen Baker, James Ghosh, Debashis Adams, Emily R. Duthie, Malcolm S. Hossain, Md. Sakhawat Basher, Ariful Nath, Proggananda Aktar, Fatima Cruz, Israel Mondal, Dinesh Front Cell Infect Microbiol Cellular and Infection Microbiology 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. Frontiers Media S.A. 2021-04-26 /pmc/articles/PMC8108992/ /pubmed/33981632 http://dx.doi.org/10.3389/fcimb.2021.670759 Text en Copyright © 2021 Hossain, Picado, Owen, Ghosh, Chowdhury, Maruf, Khan, Rashid, Nath, Baker, Ghosh, Adams, Duthie, Hossain, Basher, Nath, Aktar, Cruz and Mondal https://creativecommons.org/licenses/by/4.0/This is an open-access article distributed under the terms of the Creative Commons Attribution License (CC BY). The use, distribution or reproduction in other forums is permitted, provided the original author(s) and the copyright owner(s) are credited and that the original publication in this journal is cited, in accordance with accepted academic practice. No use, distribution or reproduction is permitted which does not comply with these terms.
spellingShingle Cellular and Infection Microbiology
Hossain, Faria
Picado, Albert
Owen, Sophie I.
Ghosh, Prakash
Chowdhury, Rajashree
Maruf, Shomik
Khan, Md. Anik Ashfaq
Rashid, Md. Utba
Nath, Rupen
Baker, James
Ghosh, Debashis
Adams, Emily R.
Duthie, Malcolm S.
Hossain, Md. Sakhawat
Basher, Ariful
Nath, Proggananda
Aktar, Fatima
Cruz, Israel
Mondal, Dinesh
Evaluation of Loopamp™ Leishmania Detection Kit and Leishmania Antigen ELISA for Post-Elimination Detection and Management of Visceral Leishmaniasis in Bangladesh
title Evaluation of Loopamp™ Leishmania Detection Kit and Leishmania Antigen ELISA for Post-Elimination Detection and Management of Visceral Leishmaniasis in Bangladesh
title_full Evaluation of Loopamp™ Leishmania Detection Kit and Leishmania Antigen ELISA for Post-Elimination Detection and Management of Visceral Leishmaniasis in Bangladesh
title_fullStr Evaluation of Loopamp™ Leishmania Detection Kit and Leishmania Antigen ELISA for Post-Elimination Detection and Management of Visceral Leishmaniasis in Bangladesh
title_full_unstemmed Evaluation of Loopamp™ Leishmania Detection Kit and Leishmania Antigen ELISA for Post-Elimination Detection and Management of Visceral Leishmaniasis in Bangladesh
title_short Evaluation of Loopamp™ Leishmania Detection Kit and Leishmania Antigen ELISA for Post-Elimination Detection and Management of Visceral Leishmaniasis in Bangladesh
title_sort evaluation of loopamp™ leishmania detection kit and leishmania antigen elisa for post-elimination detection and management of visceral leishmaniasis in bangladesh
topic Cellular and Infection Microbiology
url https://www.ncbi.nlm.nih.gov/pmc/articles/PMC8108992/
https://www.ncbi.nlm.nih.gov/pubmed/33981632
http://dx.doi.org/10.3389/fcimb.2021.670759
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