结核病诊断T-SPOT.TB、Gene Xpert MTB/RIF技术应用价值研究

Study on the value of T-SPOT.TB and Gene Xpert MTB/RIF techniques in tuberculosis diagnosis

目的评估结核分枝杆菌及其利福平耐药株实时荧光定量核酸扩增(Gene Xpert MTB/RIF)和结核感染T细胞斑点试验(T-SPOT.TB)在结核病诊断中的价值。方法分析2020年1月-2022年3月济宁市公共卫生医疗中心收治的住院及门诊病患者643病例的抗酸染色镜检、960液体培养、Gene Xpert MTB/RIF检测和结核抗体、T-SPOT.TB检测结果,评价Gene XpertMTB/RIF和T-SPOT.TB检测诊断结核病的特点和价值,以临床诊断为金标准,以检测方法的敏感度、特异度及绘制的ROC曲线等作为评价指标。结果抗酸染色、960快速培养和Gene Xpert MTB/RIF检测结核病的敏感度分别为21.57%、39.21%和59.80%,特异度分别为100.00%、97.22%和100.00%。ROC曲线分析显示,抗酸染色、960结核菌培养和Gene XpertMTB/RIF的AUC分别是0.60、0.70和0.80,差异有统计学意义(P<0.05);95%置信区间范围分别为0.50~0.70,0.61~0.78,0.73~0.87。T-SPOT.TB和结核抗体检测的敏感度分别为84.61%和70.19%,特异度分别为95.83%和79.16%。ROC曲线分析结核抗体与TSPOT检测的AUC分别为0.75和0.90,95%,置信区间范围分别为0.64~0.86和0.84~0.97。T-SPOT.TB和Gene Xpert MTB/RIF的阳性率分别为86.47%和36.60%。结论在结核病诊断中,Gene Xpert MTB/RIF和T-SPOT.TB检测结核病的敏感性高于痰涂片和痰培养检查及结核抗体检测,其中T-SPOT.TB检测的阳性率较高。Gene Xpert MTB/RIF和T-SPOT.TB均可应用于肺结核的临床诊断以提高肺结核的诊治效率。

Objective To evaluate the diagnostic value of real-time fluorescent quantitative nucleic acid amplification(Gene Xpert MTB/RIF)and T cell spot test for tuberculosis infection(T-SPOT.TB).Methods The results of acid-fast staining microscopy,960 liquid culture,Gene Xpert MTB/RIF detection,tuberculosis antibody and T-SPOT.TB detection in 643 inpatients and outpatients admitted to Jining Public Health Medical Center from January 2020 to March 2022 were analyzed.To evaluate the characteristics and value of Gene XpertMTB/RIF and T-SPOT.TB in the diagnosis of tuberculosis.The clinical diagnosis was taken as the gold standard,and the sensitivity,specificity and ROC curve of the detection method were taken as the evaluation indexes.Results The sensitivities of acid-fast staining,960 rapid culture and Gene Xpert MTB/RIF in detecting tuberculosis were 21.57%,39.21%and 59.80%,respectively,and the specifi cties were 100.00%,97.22%and 100.00%,respectively.ROC curve analysis showed that the AUC of acid-fast staining,960 tuberculus culture and Gene XpertMTB/RIF were 0.60,0.70 and 0.80,respectively,and the difference was statistically significant(P<0.05).The 95%confidence intervals were 0.50-0.70,0.61-0.78 and 0.73-0.87,respectively.The sensitivity and specificity of T-SPOT.TB and tuberculosis antibody detection were 84.61%and 70.19%,95.83%and 79.16%respectively.ROC curve analysis of tuberculosis antibody and T-SPOT.TB detection AUC were 0.75 and 0.90,95%,the range of confidence intervals were 0.64-0.86 and 0.84-0.97,respectively.The positive rates of T-SPOT.TB and Gene Xpert MTB/RIF were 86.47%and 36.60%,respectively.Conclusion In the diagnosis of tuberculosis,Gene Xpert MTB/RIF and T-SPOT.TB are more sensitive than sputum smear,sputum culture and tuberculosis antibody detection,and the positive rate of T-SPOT.TB detection is higher.Gene Xpert MTB/RIF and T-SPOT.TB can be used in the clinical diagnosis of pulmonary tuberculosis to improve the efficiency of diagnosis and treatment of pulmonary tuberculosis.