Comparison of Point-of-Care Tests for the Rapid Diagnosis of Visceral Leishmaniasis in East African Patients

Asrat Bezuneh 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

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Maowia Mukhtar 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

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Asim Abdoun 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

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Tedla Teferi 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

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Yegnasew Takele 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

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Ermias Diro 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

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Asfaw Jemaneh 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

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Welelta Shiferaw 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

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Hirut Wondimu 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

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Ajay Bhatia 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

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Randall F. Howard 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

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Hashim Ghalib 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

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Gregory C. Ireton 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

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Asrat Hailu 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

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Steven G. Reed 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

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DOI:
https://doi.org/10.4269/ajtmh.13-0759
Volume/Issue:
Volume 91: Issue 6
Page(s):
1109–1115
Restricted access
Get Permissions

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.

Author Notes

* Address correspondence to Steven G. Reed, Infectious Disease Research Institute, 1616 Eastlake Avenue E, Suite 400, Seattle, WA 98102. E-mail: steven.reed@idri.org

Financial support: This research was supported by grant No. 49932 to SGR from the Bill and Melinda Gates Foundation.

Authors' addresses: Asrat Bezuneh, Welelta Shiferaw, Hirut Wondimu, and Asrat Hailu, Department of Microbiology, Immunology and Parasitology, Addis Ababa University, Addis Ababa, Ethiopia, E-mails: asrat_bezuneh@yahoo.com, weleltas@gmail.com, hir_uywon@yahoo.com, and hailu_a2004@yahoo.com. Maowia Mukhtar and Asim Abdoun, Institute of Endemic Diseases, University of Khartoum, Khartoum, Sudan, E-mails: mmukhtar@tropmedicine.org and aasemabdoon@hotmail.com. Tedla Teferi and Asfaw Jemaneh, Leishmaniasis Research and Treatment Centre, Arba-Minch Hospital, Ethiopia, E-mails: tdlteferi@yahoo.com and asfaw2006@yahoo.com. Yegnasew Takele and Ermias Diro, Leishmaniasis Research and Treatment Centre, University of Gondar, Ethiopia, E-mails: yegnasew77@yahoo.com and ermi_diro@yahoo.com. Ajay Bhatia, BioFire Diagnostics, LLC, Salt Lake City, UT, E-mail: ajay.bhatia@biofiredx.com. Randall F. Howard, Hashim Ghalib, Gregory C. Ireton, and Steven G. Reed, Infectious Disease Research Institute, Seattle, WA, E-mails: randall.howard@idri.org, hashimghalib@gmail.com, greg.ireton@idri.org, and steven.reed@idri.org.

Copyright:
© The American Society of Tropical Medicine and Hygiene 2014
Received:
20 Dec 2013
|
Accepted:
10 Jul 2014
|
Published Online:
03 Dec 2014
Cover The American Journal of Tropical Medicine and Hygiene
The American Journal of Tropical Medicine and Hygiene
Print ISSN:
0002-9637
Online ISSN:
1476-1645
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