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A new rapid immuno-chromatographic test card for the detection of antibodies to the Mycobacterium leprae 35-kD protein is described. The new assay is compared in the same group of subjects with a direct enzyme ELISA method for 35-kD antibodies and with assays for anti-phenolic glycolipid-I (PGL-I) antibodies using a standard ELISA as well as the recently described \"dipstick\" method. Good concordance was found between the rapid methods and the corresponding ELISA methods. The detection of untreated paucibacillary leprosy by the 35-kD test card was 59% compared with 27% for the PGL-I dipstick; however, the specificity for the 35-kD test card was 90% compared with 100% for the PGL-I dipstick in an endemic population. The potential application of these new, rapid serologic methods for the diagnosis of leprosy under field conditions is discussed.

A DNA vaccine composed of the gene for the common mycobacterial secreted protein antigen 85B was demonstrated to protect the mouse foot pad against infection with Mycobacterium leprae. The protective effect was demonstrated by a 61%-88% reduction in the bacterial number, a protective effect less than that of BCG. The same DNA vaccine has been shown to protect mice against M. tuberculosis infection, and the importance of testing other candidate tuberculosis vaccines for their potential to protect against leprosy is discussed.

In Nepal, dapsone (DDS) monotherapy was introduced in 1956 and MDT in 1983, although the coverage of MDT only reached 95% more than a decade later. Since 1987, we have been testing all suitable patients for primary and secondary drug resistance using the mouse foot pad model. We have analyzed the drug sensitivities of Mycobacterium leprae isolated from skin biopsies from 268 new and relapsed cases and from patients re-starting treatment. In the period 1988 to 1999, there was a decline in the prevalence of acquired dapsone resistance and a rise in the prevalence of primary dapsone resistance. There was a complete absence of rifampin (RMP) resistance among our patients.

A new rapid immuno-chromatographic test card for the detection of antibodies to the Mycobacterium leprae 35-kD protein is described. The new assay is compared in the same group of subjects with a direct enzyme ELISA method for 35-kD antibodies and with assays for anti-phenolic glycolipid-I (PGL-I) antibodies using a standard ELISA as well as the recently described \"dipstick\" method. Good concordance was found between the rapid methods and the corresponding ELISA methods. The detection of untreated paucibacillary leprosy by the 35-kD test card was 59% compared with 27% for the PGL-I dipstick; however, the specificity for the 35-kD test card was 90% compared with 100% for the PGL-I dipstick in an endemic population. The potential application of these new, rapid serologic methods for the diagnosis of leprosy under field conditions is discussed.

Measurements of anti-phenolic glycolipid-I antibodies were made in 200 matched samples of capillary blood from the skin-smear site, venous blood collected on filter paper, and sera. A close correlation among the three samples was observed and a weaker correlation among the antibody levels and the average and skin-smear bacterial index. Capillary blood from the skin-smear site had a consistently higher level of antibodies in each sample than did the sera. The collection of capillary blood from skin-smear sites is a convenient and economical method of obtaining samples for serology and for measuring local antibody levels, and it may be more sensitive than measurements of antibodies in sera.

Although multidrug therapy (MDT) was introduced into Nepal in 1983, the MDT coverage only recently exceeded 67%. In view of the large number of patients who were still receiving dapsone monotherapy, it is relevant to investigate the current levels of dapsone and rifampin resistance. The study was undertaken at a leprosy referral hospital near Kathmandu. Over a 5 1/2-year period, 157 leprosy patients with a bacterial index (BI) > or = 2.0 were investigated for drug resistance according to the method of Rees. Among previously untreated cases, 6% of 88 isolates showed low-dose dapsone resistance; among previously treated patients with a presumed relapse, 47% of 34 isolates demonstrated dapsone resistance. In the remaining 35 cases there was no growth in control mice. Rifampin resistance was not confirmed in any case.

Measurements of anti-phenolic glycolipid-I antibodies were made in 200 matched samples of capillary blood from the skin-smear site, venous blood collected on filter paper, and sera. A close correlation among the three samples was observed and a weaker correlation among the antibody levels and the average and skin-smear bacterial index. Capillary blood from the skin-smear site had a consistently higher level of antibodies in each sample than did the sera. The collection of capillary blood from skin-smear sites is a convenient and economical method of obtaining samples for serology and for measuring local antibody levels, and it may be more sensitive than measurements of antibodies in sera.