结核分枝杆菌IgG和IgM抗体检测试剂临床应用价值的研究

Clinical value of IgG and IgM antibody detection reagents for Mycobacterium tuberculosis

目的 评估结核分枝杆菌IgG和IgM抗体检测试剂的临床价值。方法 评估实验分2次进行：（1）于 2014年5月选择于解放军第三〇九医院就诊的患者,经病历回顾性分析分为肺结核组（92例）和非结核对照组（99例）,同时,选取94名健康对照者。（2）于2016年12月至2017年3月共选取解放军第三〇九医院就诊的118例患者血清标本,经病历回顾性分析分为结核病组（62例）和非结核对照组（56例）。对痰和支气管灌洗液进行涂片检查,收集研究对象血清标本应用结核分枝杆菌IgG和IgM抗体检测试剂盒（胶体金免疫层析法）进行检测。结果 第1次实验：应用结核分枝杆菌IgG和IgM抗体检测试剂盒检测研究对象血清中抗结核抗体的敏感度为64.1%（59/92）,特异度为89.1%（172/193）,阳性预测值为73.8%（59/80）,阴性预测值为83.9%（172/205）,一致率为81.1%（231/285）。92例肺结核患者中,IgG抗体检测的阳性率为64.1%（59/92）,其中涂阳肺结核患者的阳性率为73.8%（31/42）,涂阴肺结核患者的阳性率为56.0%（28/50）,差异无统计学意义（χ2=3.15,P=0.076）;而IgM检测均为阴性。第2次实验：应用结核分枝杆菌IgG和IgM抗体检测试剂盒检测118例研究对象血清中不同抗结核抗体的敏感度为45.2%（28/62）,特异度为78.6%（44/56）,阳性预测值为70.7%（29/41）,阴性预测值57.1%（44/77）,一致率为61.9%（73/118）。62例结核病患者中,IgG抗体检测的阳性率为45.2%（28/62）,其中,涂阳肺结核患者的阳性率为56.3%（18/32）,明显高于涂阴肺结核患者的29.2%（7/24）,差异有统计学意义（χ2=4.07,P=0.044）;而IgM检测只有1例阳性,阳性率为1.6%（1/62）。结论 结核分枝杆菌IgG和IgM抗体检测试剂中,IgG检测对活动性结核病具有较好的辅助诊断价值,而IgM检测的临床价值尚需进一步评估。

Objective To study the clinical value of Mycobacterium tuberculosis IgG and IgM antibody detection reagents. Methods The clinical value was detected in two study periods. In the first study period, the patients who visited the 309th Hospital of Chinese PLA in May 2014 were included. By retrospectively analyzing the medical records, there were 92 patients with pulmonary tuberculosis （TB） and 99 patients without TB. Ninety-four healthy volunteers in the same period were selected as controls. In the second study period, 118 patients who visited the 309th Hospital of Chinese PLA between December 2016 and March 2017 were collected, including 62 cases with pulmonary TB and 56 patients without TB. The samples of all subjects were collected for smear detection and evaluation using Mycobacterium tuberculosis IgG and IgM antibody detection kit （i.e. Immune colloidal gold technique）. Results In the first study, the sensitivity, specificity, positive predictive value, negative predictive value and consistency rate of IgG and IgM antibody detection were 64.1% （59/92）, 89.1% （172/193）, 73.8% （59/80）, 83.9% （172/205） and 81.1% （231/285）, respectively. Of the 92 pulmonary TB cases, the positive rate of IgG antibody detection was 64.1%. The positive rate was 73.8% （31/42） in the smear-positive pulmonary TB cases and 56.0% （28/50） in the smear-negative pulmonary TB cases; the difference was not statistical significant （χ2=3.15, P=0.076）. All pulmonary TB cases were detected as negative by IgM antibody detection. In the second study, the sensitivity, specificity, positive predictive value, negative predictive value and consistency rate of IgG and IgM antibody detection for the TB diagnosis were 45.2% （28/62）, 78.6% （44/56）, 70.7% （29/41）, 57.1% （44/77） and 61.9% （73/118）, respectively. Among the 62 pulmonary TB cases, the positive rate of IgG antibody detection was 45.2% （28/62）. The positive rate was 56.3% （18/32） in the smear-positive pulmonary TB cases, which was significantly higher than that of 29.2% （7/24） in the smear-negative pulmonary TB cases （χ2=4.07, P=0.044）. Whereas there was only one case detected as positive by IgM antibody detection, yielding a positive rate of 1.6% （1/62）. Conclusion The IgG in Mycobacterium tuberculosis IgG and IgM antibody tests had a better auxiliary diagnostic value for active TB, while the clinical value of IgM test requires to be further evaluated.