02424nas a2200349   4500000000100000008004100001260001600042653001300058653001600071653001700087653001200104653001400116653001300130100001300143700001900156700001700175700001500192700001300207700001200220700001400232700001600246700002200262700002000284700002100304700001100325245014300336300001000479490000700489050001600496520154800512022001402060       2014                            d  c2014 Feb 2410aSerology10aPhilippines10aMycobacteria10aleprosy10adiagnosis10aColombia1 aDuthie M1 aRaychaudhuri R1 aTutterrow YL1 aMisquith A1 aBowman J1 aCasey A1 aBalagon M1 aMaghanoy AA1 aBeltran-Alzate JC1 aRomero-Alzate M1 aCardona-Castro N1 aReed S00aA rapid ELISA for the diagnosis of MB leprosy based on complementary detection of antibodies against a novel protein-glycolipid conjugate.  a233-90 v79  aDUTHIE2014B3 a<p>Despite the widespread use of multidrug therapy for treatment, delays in clinical recognition and under-reporting of leprosy indicate that Mycobacterium leprae transmission is continuing. Thus, leprosy is likely to persist as a significant burden on health systems in many regions. In this study, we combined 2 previously characterized leprosy antigens, leprosy IDRI diagnostic-1 (LID-1) and ND-O, into the single fusion complex (ND-O-LID) and determined the serum antibody responses of leprosy patients from Colombia and the Philippines. Following confirmation that antibodies recognized each component within the conjugate, we assessed the performance of a rapid enzyme-linked immunosorbent assay (ELISA) system (Leprosy Detect(TM) fast ELISA; InBios International, Inc., Seattle, WA, USA) based on ND-O-LID capable of generating results within 1.5hours of sample addition. We found ELISA results correlated with the bacteriological index and Ridley-Jopling categorization, with lepromatous leprosy patients having the highest responses, while those of borderline tuberculoid patients were lower. Multibacillary (MB) leprosy patients were distinguished with a high degree of sensitivity (95.7%) and specificity (93.2%), suggesting that this ELISA could potentially replace invasive and insensitive skin slit smear procedures that require expert microscopic examinations. Due to the speed and robustness of this assay, we believe this is an excellent tool for detecting MB leprosy patients in a simple and highly-quantitative manner.</p>
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