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Clinical and Vaccine Immunology, November 2007, p. 1400-1408, Vol. 14, No. 11
1071-412X/07/$08.00+0     doi:10.1128/CVI.00299-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.

Use of Protein Antigens for Early Serological Diagnosis of Leprosy{triangledown}

Malcolm S. Duthie,1* Wakako Goto,1 Greg C. Ireton,1 Stephen T. Reece,1 Ludimila P. V. Cardoso,2 Celina M. T. Martelli,2 Mariane M. A. Stefani,2 Maria Nakatani,3 Robson Crusue de Jesus,3 Eduardo M. Netto,3 Ma V. F. Balagon,4 Esterlina Tan,4 Robert H. Gelber,4 Yumi Maeda,5 Masahiko Makino,5 Dan Hoft,6 and Steven G. Reed1

Infectious Disease Research Institute, 1124 Columbia St., Suite 400, Seattle, Washington 98104,1 Tropical Pathology and Public Health Institute, Federal University of Goiás, Goiânia, Brazil,2 Federal University of Bahia, Salvador, Brazil,3 Leonard Wood Memorial Center for Leprosy Research, Cebu City, Philippines,4 Department of Microbiology, Leprosy Research Center, National Institute of Infectious Diseases, Tokyo, Japan,5 Department of Microbiology and Immunology, St. Louis University, St. Louis, Missouri 631106

Received 18 July 2007/ Returned for modification 16 August 2007/ Accepted 28 August 2007

Leprosy is a chronic and debilitating human disease caused by infection with the Mycobacterium leprae bacillus. Despite the marked reduction in the number of registered worldwide leprosy cases as a result of the widespread use of multidrug therapy, the number of new cases detected each year remains relatively stable. This indicates that M. leprae is still being transmitted and that, without earlier diagnosis, M. leprae infection will continue to pose a health problem. Current diagnostic techniques, based on the appearance of clinical symptoms or of immunoglobulin M (IgM) antibodies that recognize the bacterial phenolic glycolipid I, are unable to reliably identify early-stage leprosy. In this study we examine the ability of IgG within leprosy patient sera to bind several M. leprae protein antigens. As expected, multibacillary leprosy patients provided stronger responses than paucibacillary leprosy patients. We demonstrate that the geographic locations of the patients can influence the antigens they recognize but that ML0405 and ML2331 are recognized by sera from diverse regions (the Philippines, coastal and central Brazil, and Japan). A fusion construct of these two proteins (designated leprosy IDRI diagnostic 1 [LID-1]) retained the diagnostic activity of the component antigens. Upon testing against a panel of prospective sera from individuals who developed leprosy, we determined that LID-1 was capable of diagnosing leprosy 6 to 8 months before the onset of clinical symptoms. A serological diagnostic test capable of identifying and allowing treatment of early-stage leprosy could reduce transmission, prevent functional disabilities and stigmatizing deformities, and facilitate leprosy eradication.

* Corresponding author. Mailing address: Infectious Disease Research Institute, 1124 Columbia St., Suite 400, Seattle, WA 98104. Phone: (206) 330-2517. Fax: (206) 381-3678. E-mail: mduthie{at}idri.org

{triangledown} Published ahead of print on 26 September 2007.

Clinical and Vaccine Immunology, November 2007, p. 1400-1408, Vol. 14, No. 11
1071-412X/07/$08.00+0     doi:10.1128/CVI.00299-07
Copyright © 2007, American Society for Microbiology. All Rights Reserved.



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