Sinha S, Sengupta U, Ramu G, Ivanyi J
Int J Lepr Other Mycobact Dis. 1985 Mar;53(1):33-8.
A serological antibody competition test (SACT) using a murine anti-Mycobacterium leprae-specific monoclonal antibody (ML04) has been evaluated in 96 untreated leprosy patients and 128 control subjects. The test is based on the competitive inhibition by antibodies from human test sera of the binding of the specific 125I-ML04 murine monoclonal antibody to M. leprae soluble antigen coated microtiter plates. Along the spectrum of the disease, SACT positivity was observed in 100% of LL-BL, 87.5% of BB, and 46.7% of the TT-BT groups of patients. Moreover, 46.4% of apparently healthy household family contacts of multibacillary leprosy cases were also antibody positive. Sera from 15 contacts of paucibacillary leprosy cases as well as from 85 various nonleprosy subjects (tuberculosis, autoimmune disease, cancer, and healthy) were all found to be negative. These results satisfy the requirements of a leprosy-specific serodiagnostic test. The striking increase of antibody titer in all of the LL/BL patients indicates a potential prognostic utility of this test for the lepromatous shift of the disease. The observed positivity in a fraction of healthy leprosy contacts still requires prospective evaluation of disease incidence in a larger test sample.
一项使用鼠抗麻风分枝杆菌特异性单克隆抗体（ML04）的血清学抗体竞争试验（SACT）已在96例未经治疗的麻风病患者和128名对照受试者中进行了评估。该试验基于人检测血清中的抗体对特异性125I - ML04鼠单克隆抗体与包被在微量滴定板上的麻风分枝杆菌可溶性抗原结合的竞争性抑制作用。在疾病谱中，LL - BL组患者的SACT阳性率为100%，BB组为87.5%，TT - BT组为46.7%。此外，多菌型麻风病例的明显健康的家庭接触者中有46.4%的人抗体也呈阳性。来自少菌型麻风病例的15名接触者以及85名各种非麻风病受试者（结核病、自身免疫性疾病、癌症患者和健康人）的血清均为阴性。这些结果满足麻风病特异性血清诊断试验的要求。所有LL/BL患者抗体滴度的显著升高表明该试验对疾病的瘤型转变具有潜在的预后价值。在一部分健康的麻风病接触者中观察到的阳性结果仍需要在更大的试验样本中对疾病发病率进行前瞻性评估。
