Bezuneh Asrat, Mukhtar Maowia, Abdoun Asim, Teferi Tedla, Takele Yegnasew, Diro Ermias, Jemaneh Asfaw, Shiferaw Welelta, Wondimu Hirut, Bhatia Ajay, Howard Randall F, Ghalib Hashim, Ireton Gregory C, Hailu Asrat, Reed Steven G
Department of Microbiology, Immunology and Parasitology, Addis Ababa University, Addis Ababa, Ethiopia; Institute of Endemic Disease, University of Khartoum, Khartoum, Sudan; Leishmaniasis Research and Treatment Centre, Arba-Minch Hospital, Ethiopia; Leishmaniasis Research and Treatment Centre, University of Gondar, Ethiopia; Infectious Disease Research Institute, Seattle, Washington.
Department of Microbiology, Immunology and Parasitology, Addis Ababa University, Addis Ababa, Ethiopia; Institute of Endemic Disease, University of Khartoum, Khartoum, Sudan; Leishmaniasis Research and Treatment Centre, Arba-Minch Hospital, Ethiopia; Leishmaniasis Research and Treatment Centre, University of Gondar, Ethiopia; Infectious Disease Research Institute, Seattle, Washington
Am J Trop Med Hyg. 2014 Dec;91(6):1109-15. doi: 10.4269/ajtmh.13-0759. Epub 2014 Oct 13.
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 adequate specificity to aid in the diagnosis of human visceral leishmaniasis in East Africa, Asia, and South America.
基于rK39的快速诊断检测（RDT）的开发通过提供高灵敏度和特异性，极大地辅助了内脏利什曼病的诊断，尤其是在印度次大陆和巴西。然而，这些检测在撒哈拉以南非洲地区的灵敏度和特异性较低。为了提高rK39在非洲的性能，我们构建了融合分子rK28，它保留了一些rK39重复序列，并将它们与另外两个利什曼原虫基因的重复序列相结合。这种多聚蛋白被不同商业制造商用于开发几种原型RDT，目的是以低成本形式评估相对性能。在此，我们报告了现场研究结果，表明rK28抗原能够很容易地适用于各种RDT形式，以实现高灵敏度（通常>90%）和足够的特异性，从而有助于在东非、亚洲和南美洲诊断人类内脏利什曼病。
