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中国防痨杂志 ›› 2018, Vol. 40 ›› Issue (2): 173-176.doi: 10.3969/j.issn.1000-6621.2018.02.012

• 论著 • 上一篇    下一篇

三种检测技术对肺结核辅助诊断价值的研究

史祥,尹洪云,沙巍,肖和平()   

  1. 200433 同济大学附属上海市肺科医院结核科 上海市结核(肺)重点实验室 上海市肺科医院结核病临床研究中心
  • 收稿日期:2017-04-28 出版日期:2018-02-10 发布日期:2018-03-14

Study on the value of three kinds of detection techniques for the diagnosis of pulmonary tuberculosis

Xiang SHI,Hong-yun YIN,Wei SHA,He-ping. XIAO()   

  1. Shanghai Pulmonary Hospital, Tongji University; Shanghai Key Laboratory for (Pulmonary) Tuberculosis; the Clinical Study Center of Tuberculosis, Shanghai 200433, China
  • Received:2017-04-28 Online:2018-02-10 Published:2018-03-14

摘要: 目的

评价痰液结核分枝杆菌采用实时荧光核酸恒温扩增检测技术(simultaneous amplification and testing,SAT)、外周血结核感染T淋巴细胞斑点试验(T-SPOT.TB)及血清结核抗体(TB-Ab)检测等3种检测方法对肺结核的辅助诊断价值。

方法

选取上海市肺科医院2014年11月至2015年10月期间临床确诊为肺结核的住院患者作为肺结核组,共689例。选取同时期上海市肺科医院住院的肺部非结核性疾病患者作为非肺结核组,共291例。收集研究对象临床资料及T-SPOT.TB、SAT、血清TB-Ab检测结果,以肺结核临床诊断为金标准,计算3种方法单独及联合检测(3种方法联合检测时任一种方法检测结果阳性则诊断为肺结核,联合检测结果均为阴性时判断为阴性)的诊断效能指标,并绘制受试者工作曲线(ROC曲线),评价其对肺结核的诊断价值。

结果

T-SPOT.TB检测敏感度为90.67%(593/654),特异度为68.09%(192/282)。SAT检测敏感度为30.43%(133/437),特异度为100.00%(87/87)。TB-Ab检测敏感度为43.95%(298/678),特异度为78.82%(227/288)。3种方法联合检测的敏感度为93.14%(285/306),特异度为53.41%(47/88);T-SPOT.TB和TB-Ab联合检测的敏感度为92.83%(440/474),特异度为52.11%(148/284)。绘制3种检测方法诊断肺结核的ROC曲线,T-SPOT.TB、SAT检测对应的曲线下面积(AUC)分别为0.798和0.652;T-SPOT.TB+SAT+TB-Ab、T-SPOT.TB+TB-Ab联合检测对应的AUC值分别为0.865和0.843。

结论

T-SPOT.TB、SAT及TB-Ab联合检测辅助诊断肺结核价值较高,T-SPOT.TB和TB-Ab联合检测次之;单项检测中,SAT检测特异度最高,T-SPOT.TB 诊断价值最大。

关键词: 结核, 肺, 诊断技术和方法, 评价研究, 数据说明, 统计

Abstract: Objective

To evaluate the diagnostic value of sputum simultaneous amplification and testing (SAT) for tuberculosis (TB), peripheral blood T-SPOT.TB and serum TB-Ab in patients with pulmonary tuberculosis.

Methods

By reviewing the clinical data and tests results (T-SPOT.TB, SAT and serum TB-Ab) of 980 patients hospitalized in Shanghai Pulmonary Hospital (689 patients with pulmonary tuberculosis and 291 patients with non-tuberculosis lung diseases) from Nov 2014 to Oct 2015, the diagnostic sensitivity and specificity of the three methods were compared. Taking the clinical diagnosis of pulmonary tuberculosis as the gold standard, we calculated the diagnostic efficiency indexes of the three methods, while they were separately or jointly tested in these patients, and drew the receiver operating characteristic (ROC) curves to evaluate their diagnostic value for tuberculosis. As to joint testing, patients were diagnosed as pulmonary tuberculosis if one of the involved tests showed positive results, whereas patients were judged as non-pulmonary tuberculosis if all involved tests showed negative results.

Results

The sensitivity of T-SPOT.TB was 90.67% (593/654), while the specificity was 68.09% (192/282). The sensitivity of SAT was 30.43% (133/437), while the specificity was 100.00% (87/87). The sensitivity of TB-Ab was 43.95% (298/678), while the specificity was 78.82% (227/288). The sensitivity of the co-detection of the three methods was 93.14% (285/306), while the specificity was 53.41% (47/88). The sensitivity of T-SPOT.TB combined with TB-Ab was 92.83% (440/474), while the specificity was 52.11% (148/284). After drawing the ROC curves to evaluate T-SPOT.TB and SAT detections’ performances in diagnosing pulmonary tuberculosis, T-SPOT.TB and SAT-TB tests achieved the areas under the curve (AUC) of 0.798 and 0.652, respectively; and the AUC for T-SPOT.TB+SAT+TB-Ab and T-SPOT+TB-Ab were 0.865 and 0.843, respectively.

Conclusion

The co-detection of the three methods, T-SPOT.TB, SAT and TB-Ab, was the most valuable method for the diagnosis of pulmonary tuberculosis. Combining detection of T-SPOT.TB and TB-Ab could be the second choice. If we only tested one of the three, T-SPOT.TB was the highest valuable detection for the diagnosis of pulmonary tuberculosis, and the highest specificity belonged to sputum SAT detection.

Key words: Tuberculosis, pulmonary, Diagnostic techniques and procedures, Evaluation studies, Data interpretation, statistical