FIND is evaluating two non-invasive diagnostic tests for visceral leishmaniasis (VL) in partnership with the Centre for Clinical Research, Kenyan Medical Research Institute (KEMRI). The clinical trial is designed to assess diagnostic accuracy of both tests and to assess their potential utility in treatment monitoring.
VL is a deadly parasitic disease—nearly 95% of cases are fatal if left untreated. Each year 200,000 to 400,000 new infections occur, predominantly among rural, poor communities in Sub-saharan Africa, Brazil, and the Indian subcontinent.
Early and accurate diagnosis is essential, yet there is no simple point of care test that can be used to confirm infection. The rapid tests that are available are based on detection of antibodies and have suboptimal diagnostic performance in eastern Africa. Other limitations of these tests include false positives in highly endemic regions, futility in diagnosing relapses, and reduced sensitivity in HIV co-infected patients.
In cases where confirmatory diagnosis of VL is required, it is currently necessary to demonstrate parasites in samples drawn from either the spleen, bone marrow, or lymph nodes. This invasive process is challenging in poorly-resourced health facilities. As a result, cases are often either missed, treated presumptively, or referred to centralized facilities, which implies patients have to take long, costly journeys to be diagnosed, and are increasingly likely to be lost to follow-up.
The tests in trial are designed to overcome these limitations. One is an ELISA test that detects antigens in urine and has potential both for diagnosis and treatment monitoring. It was recently developed by FIND, Kalon Biological (UK), DNDi and KEMRI and has been trialed in several other endemic regions.
The other is a molecular diagnostic test, known as LAMP, designed to detect parasite DNA in blood samples. It is a relatively easy-to-use test that can be performed in district laboratories in low resource settings, by technicians with no training in molecular biology. Trials in other locations have been conducted with promising outcomes.
The trial is being conducted in two VL treatment centres in Kenya, Kimalel hospital in Baringo County and Kacheliba hospital in Pokot County. The trial is expected to end in December 2017 with results reported in early 2018. This project has been funded by contributions from the German Federal Ministry of Education and Research, the Dutch Ministry of Foreign Affairs, the UK Department for International Development, and the Swiss Agency for Development and Cooperation.