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Development of a new point-of-care test for leprosy

Ludimila P. Cardoso1, Ronaldo F. Dias2, Aline A. Freitas1, Emerith M. Hungria1, Regiane M. Oliveira1, Marco Collovati2, Steven G. Reed3, Malcolm S. Duthie3 and Mariane A. Stefani1*
  • 1 Federal University of Goias, Tropical Pathology and Public Health Institute, Brazil
  • 2 Orange Life, Brazil
  • 3 Infectious Disease Research Institute, United States

Leprosy is a dermato-neurological disease that remains an important public health problem in many endemic countries. Leprosy presents as a spectrum and no laboratory test is commercially available for its diagnosis/prognosis. Here we report the development of a new point-of-care (POC) test for leprosy using LID-1 fusion-protein and phenolic glycolipid-I (PGL-I) (NDO-LID,Orangelife®/Brazil). A new rapid-test reader platform integrated in a cell phone was also used (Smart Reader application-SR®). NDO-LID® tests were evaluated among newly diagnosed untreated multibacillary (MB=108) and paucibacillary (PB=104) leprosy patients, (Ridley & Jopling classification); leprosy household contacts (HHC=75); pulmonary tuberculosis patients (sputum positive/HIV negative;TB=53) and healthy endemic controls (EC=101) recruited in central-western Brazil. NDO-LID® anti IgM/IgG reactivity (SR®:cut-off=10) was compared to anti PGL-I IgM ELISA (cut-off:optical density=0.250). Across the spectrum of leprosy forms (from lepromatous/LL to tuberculoid/TT pole) a gradual decrease in the seropositivity to NDO-LID® test was observed: 97.4% for LL, 83.7% for borderline lepromatous/BL, 76.9% for borderline borderline/BB patients; 26.2% for borderline tuberculoid/BT and 14% for TT patients. Seropositivity among HHC was 5.3%, 5.7% for TB and 3% among EC. The estimated sensitivity of NDO-LID® test was 87% and the specificity was 96.1%. The new NDO-LID® POC test represents a useful tool for MB leprosy detection/diagnosis and treatment and can also contribute to monitor treatment by leprosy controls programs. MB patient are important Mycobacterium leprae disseminators and are at increased risk of complications such as reactional episodes. The digital and automated rapid test SR®-app also represents an improvement towards more accurate results.

Acknowledgements

This study was supported by American Leprosy Missions, Renaissance Health Service Corporation and PRONEX/FAPEG/CNPq-07/2009. Dr. Mariane M. A. Stefani is a recipient of a fellowship from CNPq (grant # 304869/2008-2) and Dr. Ludimila Cardoso was supported by a fellowship from CAPES (grant#02479/09-5). We thank Dr. Fujiwara (Institute for Natural Science, Nara University, Nara, Japan) for kindly providing the NTP-BSA antigen.

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Keywords: Leprosy, Serologic Response, lateral flow, immunochromatographic test, Brazil

Conference: 15th International Congress of Immunology (ICI), Milan, Italy, 22 Aug - 27 Aug, 2013.

Presentation Type: Abstract

Topic: Adaptive Immunity

Citation: Cardoso LP, Dias RF, Freitas AA, Hungria EM, Oliveira RM, Collovati M, Reed SG, Duthie MS and Stefani MA (2013). Development of a new point-of-care test for leprosy. Front. Immunol. Conference Abstract: 15th International Congress of Immunology (ICI). doi: 10.3389/conf.fimmu.2013.02.00716

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Received: 13 Jun 2013; Published Online: 22 Aug 2013.

* Correspondence: Dr. Mariane A Stefani, Federal University of Goias, Tropical Pathology and Public Health Institute, Goiania, Goias, 74605050, Brazil, mmastefani@gmail.com