Abstract:
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The development of rK39-based rapid diagnostic tests (RDTs) has greatly aided the diagnosis of visceral
leishmaniasis, especially in the Indian subcontinent and Brazil, by offering high sensitivity and specificity. However,
these tests have been less sensitive and less specific in sub-Saharan Africa. To improve upon the performance of rK39 in
Africa, we engineered the fusion molecule rK28, which retained some of the rK39 repeats and combined them with
repeat sequences from two additional Leishmania genes. This polyprotein was used in the development of several
prototype RDTs by different commercial manufacturers with the goal of assessing relative performance in inexpensive
formats. Here, we report field studies showing that the rK28 antigen could be readily adapted to a variety of RDT
formats to achieve high sensitivity, generally > 90%, and |