抗结核分枝杆菌多种抗原的抗体检测蛋白芯片研究

Establishment and clinical application of protein chip for detection of antibodies to multiple Mycobacerium tuberculosis antigens

目的 建立检测结核分枝杆菌多抗原IgG抗体的蛋白芯片检测系统 ,并验证抗结核分枝杆菌多种抗原的抗体检测蛋白芯片的临床应用价值。 方法 采用棋盘滴定法标定检测结核菌抗体的包被蛋白及金标记二抗的最低工作浓度 ,建立完整的检测系统。结核病人和正常对照者的血清经芯片识别仪和DIGFA法试剂同时检测 ,计算敏感性、特异性和总符合率。 结果 结核芯片系统检测的敏感性、特异性、阳性预测值、阴性预测值和诊断效率分别为76 74% (3 5 3 /4 60 )、81 70 %、5 6 48%、91 90 %和 15 8 44 %。而DIGFA法检测的敏感性、特异性分别为 68 3 1% (2 91/4 2 6)和 72 2 %。两者检测的总符合率为 85 2 1%。检测结果间无显著性差异 (χ2 =6,P >0 0 5 )。全部检测过程只需 5min。 结论 芯片系统检测的敏感性和特异性符合临床检验要求 ,具有简便、快速和单人份操作的优点 ,可用于临床快速诊断结核病。

Objective To establish an protein chip assay for detection antibodies toM. tuberculosis and evaluate the protein chip for detection of the antibodies to the multiple antigens of M tuberctdosis. Methods Both the protein chips for detection of the IgG antibodies to multiple All. tuberculosis antigens and a DIGFA assay were employed to detect antibodies to M tuberculosis simultaneously. Results The sensitivity, specificity, positive and negative predictive rates, and diagnosis index of the protein chip system we developed were 76.74% (353/460) , 81.70%, 56.48%, 91.90% and 158.44% respectively. The sensitivity and specificity of the DIGFA assay (control method) were 68.31%(291/426) and 72.0% respectively. There was no significant difference between the two methods (χ2=0.6,P>0.05). Conclusions The TB protein chip system is simple, sensitive and specific for detection M tuberculosis antibodies. So it is an idea method tbr early and rapid sera diagnosis of tuberculosis.