02521nas a2200313 4500000000100000008004100001260001300042653003100055653002600086653002300112653002800135653003800163653001500201653001100216653001000227653001200237653002500249653002500274653003200299100001400331700001200345700001200357700001400369245010600383300001200489490000700501520168500508022001402193 2006 d c2006 Oct10aAmbulatory Care Facilities10aAntibodies, Bacterial10aBacterial Proteins10aDiagnosis, Differential10aEnzyme-Linked Immunosorbent Assay10aFiltration10aHumans10aIndia10aleprosy10aMycobacterium leprae10aRecombinant Proteins10aSensitivity and Specificity1 aParkash O1 aKumar A1 aNigam A1 aGirdhar B00aDetection of antibodies against Mycobacterium leprae culture filtrate protein-10 in leprosy patients. a1337-410 v553 a

The prevalence of IgG antibodies against Mycobacterium leprae recombinant culture filtrate protein-10 (rCFP-10) was investigated in serum samples from 56 leprosy patients, 15 tuberculosis (TB) patients, 14 other skin-diseased patients and 20 healthy subjects. On classifying the patients into bacterial index (BI)-positive and BI-negative groups, the assay showed 83.3 % (15/18) sensitivity for detection of BI-positive leprosy patients. On the other hand, the sensitivity for detection of BI-negative patients was 18.4 % (7/38). None of the 15 TB patients and 14 other skin-diseased patients was positive; however, only one out of 20 healthy individuals was positive, indicating that antibody response to culture filtrate protein-10 (CFP-10) was highly specific (98.0 %; 48/49). Statistically, the performance of the CFP-10-based assay was found to be comparable (P>0.05) with that of an anti-phenolic glycolipid-I (PGL-I) antibody-detecting assay. Thus, M. leprae CFP-10 is potentially a specific antigen for measuring antibody response in BI-positive leprosy patients. Being a secreted antigen, CFP-10 may act as a marker for the viability of M. leprae inside the host, and hence its serological potential is worth exploring for application in monitoring the response of patients with BI-positive leprosy (a highly infectious form) during the course of chemotherapy. When comparing the bacteriological and serological results, an agreement of 82.1 % showed that seropositivity to M. leprae CFP-10 corresponded well with bacteriological criteria. Hence, CFP-10 seems to be a suitable antigen for classification of leprosy patients into BI-positive and BI-negative groups.

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