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.

译文

在56名麻风病患者,15名结核病 (TB) 患者,14名其他皮肤病患者和20名健康受试者的血清样本中,研究了针对麻风分枝杆菌重组培养滤液蛋白10 (rCFP-10) 的IgG抗体的患病率。在将患者分为细菌指数 (BI) 阳性和BI阴性组时,该测定显示了检测BI阳性麻风病患者的83.3% (15/18) 敏感性。另一方面,检测双阴性患者的灵敏度18.4% (7/38)。15个TB患者和14个其他皮肤疾病患者中没有一个是阳性的; 然而,20个健康个体中只有一个是阳性的,表明对培养滤液蛋白10 (CFP-10) 的抗体反应是高度特异性的 (98.0%; 48/49)。统计学上,发现CFP-10-based测定的性能与抗-酚糖脂-I (pgl-i) 抗体检测测定的性能相当 (P>0.05)。因此,麻风分枝杆菌CFP-10潜在地是用于测量双阳性麻风病患者的抗体应答的特异性抗原。作为一种分泌的抗原,CFP-10可以作为宿主内麻风支原体生存能力的标志物,因此其血清学潜力值得探索,用于监测双阳性麻风病 (一种高度感染形式) 患者在化疗过程中的反应。当比较细菌学和血清学结果时,82.1% 的一致性表明麻风分枝杆菌的血清阳性CFP-10与细菌学标准非常吻合。因此,CFP-10似乎是用于将麻风病患者分为双阳性和双阴性组的合适抗原。

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