胶体金免疫层析法检测结核分枝杆菌特异性IgG/IgM抗体对结核病诊断的应用价值

目的 评价胶体金免疫层析法检测血清中结核分枝杆菌特异性IgG/IgM抗体在结核病诊断中的应用价值。方法 收集结核病患者和健康人的血清样本共332份及其背景资料,采用胶体金法检测血清中特异性结核抗体IgG/IgM,与临床诊断和细菌学检测结果比较,使用SPSS 22.0统计软件对结果进行比较分析,以P<0.05为差异具有统计学意义。结果 胶体金免疫层析法检测结核病患者中特异性结核抗体IgG/IgM的灵敏度为41.15%、特异性为91.67%,检测菌阳和菌阴结核病患者的敏感性分别为51.38%和33.77%。在全部结核病患者中,特异性结核抗体IgG/IgM检测检出率(41.15%)显著高于痰涂片法(18.84%)和痰菌培养法(36.15%)(P<0.05)。结核抗体检测、痰涂片法和痰培养法三种方法联合检测阳性率为61.54%,高于单种方法检测或其中两种方法联合检测。结论 胶体金免疫层析法检测血清中结核分枝杆菌抗体具有灵敏、特异、快速和简便等优点,可用于结核病的筛查,同时该方法也具有一定的局限性,敏感度和特异度有待进一步的提高,因此不可单独用于诊断结核病,可配合痰细菌学、影像学和临床表现等进行辅助诊断。

Application value of detecting Mycobacterium tuberculosis specific IgG/IgM antibodies for tuberculosis diagnosis with colloidal gold immunochromatography assay

In this study, we estimated the application value of detecting Mycobacterium tuberculosis (MTB) specific IgG/IgM antibodies for tuberculosis diagnosis with colloidal gold immunochromatography assay (GICA). We collected 332 effective serum samples and their background information, including 260 patients with tuberculosis and 72 healthy individuals. The means of GICA was used to detect MTB specific IgG/IgM antibodies. Results were compared with the clinical diagnosis and the results of bacteriological tests. The SPSS 22.0 software was used to analyze the results, and when P<0.05 the difference was statistically significant. The sensitivity and specificity of GICA were 41.15% and 91.67%, and the sensitivity of the bacterial positive and negative patients were 51.38% and 33.77%, respectively. The positive rate of IgG/IgM antibodies detection with GICA (41.15%) was much higher than that of bacteria with acid-fast stain of sputum smear (18.84%) and sputum bacteria cultivation (36.15%) (P<0.05) respectively. The positive rate of the combination of tuberculosis antibody detection, sputum bacterial culture and sputum smear was 61.54%, higher than the result of single method or combination of two methods. The detection of specific antibodies against MTB in serum with GICA is sensitive, specific, rapid and convenient, which can be used in clinical screening. Meanwhile, there are still certain limitations of this method, and the sensitivity and specificity need to be improved. Therefore, the GICA can be used as an auxiliary diagnosis combined with sputum bacteriology,imaging test and clinical features rather than diagnose tuberculosis alone.