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

Acronym	EvaLAMP & db-NALFIA (Reference Number: TMA2016SF-1437)
Duration	01/07/2018 - 30/06/2023
Project Topic	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. 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 project includes capacity building for research in NIDs at Mekelle University College of Health Sciences in Ethiopia.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.
Network	EDCTP2
Call	Senior Fellowships 2016

Project partner

Number	Name	Role	Country
1	Mekelle University	Coordinator	Ethiopia