重组结核分枝杆菌16ku-38ku—ESAT-6融合蛋白的血清学评价  

Serological evaluation using recombinant 16 ku-38 ku-ESAT-6 protein of mycobacteriumtuberculosis

作　　者：吴俐健[1] 邹博[1] 聂芳[2] 张含玉[1] 孙美秋[1] 贾本智[1] 王笑歌[2] 

机构地区：[1]中国医科大学附属第四医院结核科,沈阳110032 [2]中国医科大学附属第四医院呼吸科,沈阳110032

出　　处：《中国医师进修杂志》2011年第13期7-10,共4页Chinese Journal of Postgraduates of Medicine

基　　金：基金项目：辽宁省自然科学基金（20092097）

摘　　要：目的 以重组结核分枝杆菌16 ku-38 ku-ESAT-6融合蛋白（以下简称重组蛋白）为包被抗原,探讨该抗原对结核病的诊断价值.方法 结核组105例、对照组45例（包括非结核病患者25例及健康体检者20例）,以重组蛋白作为包被抗原,采用酶联免疫吸附试验（ELISA）检测150例受检者血清中的重组蛋白抗体水平,得出各组之间的吸光度值及阳性率,并与结核分枝杆菌抗体胶体金法诊断试剂盒的检测结果进行比较,以此来评价重组蛋白对结核病的诊断价值,并建立受试者工作特征（ROC）曲线评价系统.结果 重组蛋白检测对照组的阳性率为6.67%（3/45）,与试剂盒检测阳性率[51.11%（23/45）]比较差异有统计学意义（P＜0.01）,结核组阳性率为59.05%（62/105）,与试剂盒检测阳性率[64.76%（68/105）]比较差异无统计学意义（P＞0.05）.结核组与对照组的吸光度值分别为2.22±0.58、1.35±0.24,两组比较差异有统计学意义（t=6.06,P＜0.01）;重组蛋白检测结核病的敏感度、特异度、阳性预测值及阴性预测值分别为59.05%、93.33%、95.38%、49.41%.应用ROC曲线分析,得出曲线下面积为0.751,cutoff值为2.52,此时敏感度及特异度分别为65.4%、84.8%.结论 重组蛋白检测血清结核抗体具有较高的特异度,可以更好地区分结核病患者群与非患者群,可以作为结核病诊断的备选抗原之一.Objective To investigate the diagnostic value of 16 ku-38 ku-ESAT-6 protein in tuberculosis （TB）. Methods ELISA was used for measuring the level of recombinant 16 ku-38 ku-ESAT-6 protein in 105 TB patients （TB group,26 patients with smear-positive, 79 patients with smear-negative） and 45 controls （control group, 20 healthy volunteers and 25 subjects with pulmonary diseases other than TB）. The value of the antigen for diagnosis of TB in serodiagnosis was assessed, and ROC curve evaluation system was established. Results In control group, the positive rate of anti-recombinant 16 ku-38 ku-ESAT-6 protein and commercialization of TB antibody test kit had significant difference [6.67% （3/45） vs. 51.11% （23/45）]（P〈0.01）;but in TB group, there was no significant difference [59.05%（62/105） vs. 64.76% （68/105）]（P〉0.05）. The optical density value in TB group and control group was 2.22 ± 0.58 and 1.35 ± 0.24,and there was significant difference（t = 6.06,P〈 0.01）. The sensitivity, specificity, positive predictive value and negative predictive value of the test was 59.05%,93.33%,95.38%,49.41% respectively. Analyzed by ROC curve, the area under the curve was 0.751, the- value of cutoff was 2.52, and sensitivity and specificity was 65.4% and 84.8%. Conclusions Recombinant 16 ku -38 ku -ESAT-6 protein of mycobacterium tuberculosis has higher specificity, and it can significantly distinguish TB and non-TB. So it might be selected as one of diagnosis antigens of TB.

关 键 词：分枝杆菌 结核 血清学 评价研究 

分 类 号：R5[医药卫生—内科学]