Diagnostic performance of a novel point-of-care test for the diagnosis of visceral leishmaniasis in Sudan : A Comparative Accuracy Study
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PLoS
Abstract
Visceral Leishmaniasis (VL), also known as Kala-azar, is a neglected tropical disease prevalent in regions such as Sudan, India, Bangladesh, and East Africa. In Sudan, VL is transmitted by the sandfly Phlebotomus orientalis, with rural areas like Gedaref and White-Nile State facing the highest burden. Despite being treatable, VL causes mortality, particularly in rural areas, due to limited access to effective diagnostics and treatment. Current diagnostic methods, including microscopic parasite detection and rK39-based rapid diagnostic tests (RDTs), are hindered by low sensitivity and are not ideal for resource-poor regions.
In response to this, a new recombinant kinesin antigen (rKLi8.3) from a Sudanese L. infantum strain has been developed to improve VL diagnosis. A prospective study was conducted in Gedaref, Eastern Sudan, to evaluate the diagnostic accuracy of this new antigen by comparing two diagnostic tests: INgezim Leishma-CROM and IT-LEISH.
In conclusion, both a previous retrospective and the current prospective study demonstrate that INgezim Leishma-CROM is suitable for field diagnosis and shows enhanced diagnostic performance in East Africa. This test offers a significantly improved alternative to the currently used RDTs in VL endemic areas.
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