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.
| Identifer | oai:union.ndltd.org:DRESDEN/oai:qucosa:de:qucosa:84534 |
| Date | 03 April 2023 |
| Creators | Hossain, Faria, Picado, Albert, Owen, Sophie I., Ghosh, Prakash, Chowdhury, Rajashree, Maruf, Shomik, Ashfaq Khan, Md. Anik, 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 |
| Publisher | Frontiers Research Foundation |
| Source Sets | Hochschulschriftenserver (HSSS) der SLUB Dresden |
| Language | English |
| Detected Language | English |
| Type | info:eu-repo/semantics/publishedVersion, doc-type:article, info:eu-repo/semantics/article, doc-type:Text |
| Rights | info:eu-repo/semantics/openAccess |
| Relation | 2235-2988, 670759 |
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