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背景:共有1360例临床确诊的肺内结核、肺外结核患者标本及其他非结核标本。目的:建立一种快速、敏感、特异的检测不同临床标本中结核分枝杆菌糖脂抗原的方法。研究设计:在1-乙基-3-3-二甲基氨丙基碳化二亚胺氢氯化物和N-羟基丁二酰胺溶液中将亲和纯化的兔抗糖脂抗体(IgG)结合在脂质体颗粒(0.2～0.4 um)上,制备TB/M检测板的反应试剂。结果:当检测样本中存在糖脂抗原时,连接抗体的脂质体在4 min内会出现1个深蓝色的凝集点。而正常健康人或其他疾病患者的样本未见凝集点。结果显示该方法检测活动性肺结核患者临床样本中的结核分枝杆菌糖脂抗原的敏感性可低至1 ng/ml,临床灵敏度为97.4%,特异性为96.9%。结论:TB/M检测试验比较经济(一次检测只需4个印度卢比或0.09美元)、快速(4 min),似乎有助于结核病流行国家大规模检测结核性脑膜炎、肺结核和其他肺外结核患者多种生物学标本(脑脊液、胸液、关节液、血清和组织活检标本)。
Background: A total of 1,360 clinically diagnosed cases of pulmonary tuberculosis, extrapulmonary tuberculosis and other non-tuberculosis specimens. Objective: To establish a rapid, sensitive and specific method for the detection of M. tuberculosis glycolipid antigens in different clinical specimens. Study Design: Affinity purified rabbit anti-glycolipid antibodies (IgG) were bound in a solution of 1-ethyl-3-dimethylaminopropylcarbodiimide hydrochloride and N-hydroxysuccinimide Liposome particles (0.2 ~ 0.4 um), preparation of TB / M detection plate reaction reagent. Results: The liposomes with antibodies attached showed a dark blue aggregation point within 4 min when the presence of glycolipid antigen in the test sample. No sample of normal healthy or other disease patients showed agglutination. The results showed that the sensitivity of this method for detection of M. tuberculosis glycolipid antigen in clinical samples from patients with active pulmonary tuberculosis can be as low as 1 ng / ml, with a clinical sensitivity of 97.4% and a specificity of 96.9%. Conclusion: The TB / M test is economical (only 4 INR or 0.09 USD per test) and fast (4 min) seems to be helpful for the large-scale detection of tuberculous meningitis, tuberculosis and other extrapulmonary tuberculosis Patients with a variety of biological specimens (CSF, pleural fluid, synovial fluid, serum and tissue biopsy specimens).