02921nas a2200481 4500000000100000008004100001260001300042653001500055653001000070653000900080653002600089653002400115653001100139653001100150653001200161653000900173653001600182653002500198653002600223653002500249100001300274700001300287700001600300700001100316700001200327700001300339700001500352700001600367700001500383700001300398700001500411700001400426700001700440700001300457700001100470245009800481856007200579300001100651490000700662050001600669520174000685022001402425 2008 d c2008 Oct10aAdolescent10aAdult10aAged10aAntibodies, Bacterial10aAntigens, Bacterial10aFemale10aHumans10aleprosy10aMale10aMiddle Aged10aMycobacterium leprae10aPoint-of-Care Systems10aRecombinant Proteins1 aDuthie M1 aIreton G1 aKanaujia GV1 aGoto W1 aLiang H1 aBhatia A1 aBusceti JM1 aMacdonald M1 aNeupane KD1 aRanjit C1 aSapkota BR1 aBalagon M1 aEsfandiari J1 aCarter D1 aReed S00aSelection of antigens and development of prototype tests for point-of-care leprosy diagnosis. uhttp://www.ncbi.nlm.nih.gov/pmc/articles/PMC2565937/pdf/0168-08.pdf a1590-70 v15 aDUTHIE 20083 a

Leprosy can be a devastating chronic infection that causes nerve function impairment and associated disfigurement. Despite the recent 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. The diagnosis of leprosy is currently based on the appearance of clinical signs and requires expert clinical, as well as labor-intensive and time-consuming laboratory or histological, evaluation. For the purpose of developing an effective, simple, rapid, and low-cost diagnostic alternative, we have analyzed the serologic antibody response to identify Mycobacterium leprae proteins that are recognized by leprosy patients. More than 100 recombinant antigens were analyzed in a protein array format to select those with discriminatory properties for leprosy diagnosis. As expected, multibacillary leprosy patients recognized more antigens with stronger antibody responses than paucibacillary leprosy patients. Our data indicate, however, that multibacillary patients can be distinguished from paucibacillary patients, and both of these groups can be segregated from endemic control groups. We went on to confirm the diagnostic properties of antigens ML0405 and ML2331 and the LID-1 fusion construct of these two proteins by enzyme-linked immunosorbent assay. We then demonstrated the performance of these antigens in rapid test formats with a goal of developing a point-of-care diagnostic test. A serological diagnostic test capable of identifying and allowing treatment of leprosy could reduce transmission, prevent functional disabilities and stigmatizing deformities, and facilitate leprosy eradication.

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