Diagnosis of visceral leishmaniasis in Ethiopia Current challenges and future prospects

Visceral leishmaniasis (VL) is a deadly neglected infectious disease caused by Leishmania parasites, affecting around 300,000 people globally and killing 20,000-30,000 cases annually. Quick, robust, and feasible diagnostic tests are needed to timely install appropriate treatment.
The general aim of the research presented in this thesis was to contribute to the improvement of the diagnosis of VL in Ethiopia, a country with the highest burden of this disease in the world. The work is centered on the assessment of the diagnostic performance of various available diagnostic tests for VL. Moreover, the development and evaluation of a novel innovative simple molecular diagnostic test, the mini-direct-on-blood-PCR Nucleic Acid Lateral Flow Immunoassay (mini-dbPCR-NALFIA), and the evaluation of another simple molecular diagnostic, Loop Mediated Isothermal Amplification (LAMP) assay, both for the diagnosis of VL in endemic areas of Ethiopia is presented. These tests, dbPCR-NALFIA and LAMP, circumvent several technical and infrastructural bottle necks that are encountered when implementing standard molecular diagnostics in resource limited settings.
The work presented in the thesis showed that the most widely employed diagnostic test, the rk39 rapid diagnostic test, has insufficient sensitivity to detect VL in Ethiopia, resulting in many patients not being properly treated. The mini-dbPCR-NALFIA and LAMP assays, on the other hand, demonstrated excellent diagnostic performance, rapidity, and feasibility for resource-limited endemic areas, warranting a transition from conventional diagnostics to molecular diagnosis. However, mini-dbPCR-NALFIA requires training and further optimization work is might be necessary.