Current Organisation

Mekelle University College of Health Sciences (MUCHS)

Current Job Title

Associate Prof of Medicine

Biography

Publications

Project Title

Evaluation of the LAMP & db-PCR-NALFIA for the Diagnosis and/or as Test-of-Cure in Patients with Visceral Leishmaniasis in Ethiopia

EDCTP Project Call

Senior Fellowship (SF)

Host Organisation

Project Objectives

To assess the use of the LAMP assay as a diagnostic and/or ToC for VL in Ethiopia and to further develop the db-PCR-NALFIA platform for VL.

Study Design

cross-sectional study

Project Summary

Leishmaniasis is among the World’s important neglected infectious diseases (NIDs). The WHO estimates that 350 million people are at risk of contracting leishmaniasis. Visceral leishmaniasis (VL) is the most severe form of the disease. Ethiopia has been recently listed by WHO among the fourteen countries in the world with the highest burden of VL. The development of novel point-of-care (PoC) diagnostics and/or a test-of-cure (ToC) for VL is deemed a key priority research area. In several endemic areas current gold standard diagnosis and monitoring of treatment efficacy of VL is based on parasite detection or serology. However, these tests are either not available for routine use or lack sufficient sensitivity and specificity, in particular in HIV co-infected patients. Though molecular tests such as PCR have become popular choices as a tool to diagnose VL, monitor treatment response and predict relapse, these techniques require technical skill and equipment and are considerably more expensive. Recent advances in diagnostics has been the development of loop-mediated isothermal amplification (LAMP) with several advantages, such as no need for thermocycler, high specificity, simple read-out and no cold chain requirements. Therefore, LAMP has emerged as a powerful tool for PoC diagnostics. Its clinical utility as PoC diagnosis and/or ToC for VL in the African setting is, however, hardly known. Here, we will investigate the utility of the LAMP as a PoC and/or ToC for VL in an endemic area of Ethiopia. We will assess the performance of the LAMP assay as a diagnostic tool in newly diagnosed VL cases confirmed by parasite detection and/or PCR. Furthermore, the use of the assay as ToC will be determined by evaluating the performance of the assay in VL patients confirmed cured at day 30 of therapy, as assessed by negative parasite and/or PCR results. Additionally, we plan to utilize a newly developed rapid molecular platform, direct blood PCR nucleic-acid lateral-flow immunoassay (db-PCR-NALFIA), which does not require DNA extraction, has an internal amplification control and simple read-out. We will evaluate the utility of both assays also in patients co-infected with HIV. The results may have major policy implications as the application represents a concept that could enhance evidence-based translation of research to improve public health practice by contributing to leishmaniasis management guidelines – with overarching impacts for National, Regional and Global programs

Results & Outcomes