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Journal of Clinical Microbiology, May 2003, p. 1991-1995, Vol. 41, No. 5
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.5.1991-1995.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.

Simple and Fast Lateral Flow Test for Classification of Leprosy Patients and Identification of Contacts with High Risk of Developing Leprosy

S. Bührer-Sékula,1* H. L. Smits,1 G. C. Gussenhoven,1 J. van Leeuwen,1 S. Amador,2 T. Fujiwara,3 P. R. Klatser,1 and L. Oskam1

KIT (Royal Tropical Institute) Biomedical Research, 1105 AZ Amsterdam, The Netherlands,1 Department of Microbiology, Instituto Evandro Chagas, Belém, Pará, Brazil,2 Institute for Natural Science, Nara University, Nara 631-8502, Japan3

Received 9 December 2002/ Returned for modification 15 January 2003/ Accepted 11 February 2003

The interruption of leprosy transmission is one of the main challenges for leprosy control programs since no consistent evidence exists that transmission has been reduced after the introduction of multidrug therapy. Sources of infection are primarily people with high loads of bacteria with or without clinical signs of leprosy. The availability of a simple test system for the detection of antibodies to phenolic glycolipid-I (PGL-I) of Mycobacterium leprae to identify these individuals may be important in the prevention of transmission. We have developed a lateral flow assay, the ML Flow test, for the detection of antibodies to PGL-I which takes only 10 min to perform. An agreement of 91% was observed between enzyme-linked immunosorbent assay and our test; the agreement beyond chance (kappa value) was 0.77. We evaluated the use of whole blood by comparing 539 blood and serum samples from an area of high endemicity. The observed agreement was 85.9% (kappa = 0.70). Storage of the lateral flow test and the running buffer at 28°C for up to 1 year did not influence the results of the assay. The sensitivity of the ML Flow test in correctly classifying MB patients was 97.4%. The specificity of the ML Flow test, based on the results of the control group, was 90.2%. The ML Flow test is a fast and easy-to-perform method for the detection of immunoglobulin M antibodies to PGL-I of M. leprae. It does not require any special equipment, and the highly stable reagents make the test robust and suitable for use in tropical countries.

* Corresponding author. Mailing address: KIT Biomedical Research, Meibergdreef 39, 1105 AZ Amsterdam, The Netherlands. Phone: 31 20 5665449. Fax: 31 20 6971841. E-mail: s.buhrer{at}kit.nl.

Journal of Clinical Microbiology, May 2003, p. 1991-1995, Vol. 41, No. 5
0095-1137/03/$08.00+0     DOI: 10.1128/JCM.41.5.1991-1995.2003
Copyright © 2003, American Society for Microbiology. All Rights Reserved.



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