02035nas a2200361 4500000000100000008004100001260001300042653001200055653002600067653001100093653001000104653001900114653002000133653003800153653001100191653002100202653001200223653002500235653003000260653003200290653002600322100001000348700001100358700001100369700001000380700001200390700000900402245009900411300001100510490000700521520113100528022001401659 2013 d c2013 May10aAnimals10aAntibodies, Bacterial10aCattle10aChina10aDNA, Bacterial10aEarly Diagnosis10aEnzyme-Linked Immunosorbent Assay10aHumans10aImmunoglobulin M10aleprosy10aMycobacterium leprae10apolymerase chain reaction10aSensitivity and Specificity10aSerum Albumin, Bovine1 aWen Y1 aXing Y1 aYuan L1 aLiu J1 aZhang Y1 aLi H00aWhole-blood nested-PCR amplification of M. leprae-specific DNA for early diagnosis of leprosy. a918-220 v883 a

We evaluated the sensitivity and specificity of a nested-polymerase chain reaction (PCR) method for detection of Mycobacterium leprae DNA from whole blood. Whole-blood specimens were subjected to nested-PCR amplification of M. leprae repeat DNA sequences in 49 multibacillary (MB) and 30 paucibacillary (PB) leprosy patients, 96 household contacts (HHCs), 18 tuberculosis (TB) patients, and 35 normal healthy individuals. M. leprae DNA was detected in 95.92% (47/49) of MB, 70% (21/30) of PB, and 6.25% (6/96) of HHC, but it was not detected in 18 TB or 35 normal controls. The sensitivities of the anti-bovine serum albumin (ND-O-BSA) immunoglobulin M (IgM) and antifusion protein of ML0405-ML2331 IgG for MB were 97.96% and 89.8%, and these values for PB were 70% and 53.33%. However, the ND-O-BSA enzyme-linked immunosorbent assay (ELISA) had lower specificity, with relatively high false-positive results for TB patients (16.67%) and normal healthy controls (10%). Based on these promising findings, we propose the use of nested PCR of whole-blood samples along with ELISA test for early detection of leprosy cases.

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