运用ROC曲线对γ-干扰素释放试验、抗-结核分枝杆菌及其组合在涂阴肺结核诊断中的效能分析

doi:10.3877/cma.j.issn.1674-1358.2016.06.007

中华实验和临床感染病杂志(电子版) ›› 2016, Vol. 10 ›› Issue (06) : 680 -684. doi: 10.3877/cma.j.issn.1674-1358.2016.06.007

临床论著

运用ROC曲线对γ-干扰素释放试验、抗-结核分枝杆菌及其组合在涂阴肺结核诊断中的效能分析

沈兴华¹, 张晓龙², 唐佩军¹, 王雪峰³, 胥萍¹, 陈兴年¹, 汤伟¹, 吴妹英¹^,^†(

)

^1. 215007　苏州市，苏州大学附属传染病医院结核病科
^2. 215007　苏州市，苏州市疾病预防与控制中心结核病防制所
^3. 215123　苏州市，苏州大学医学部基础医学与生物科学学院

收稿日期:2015-11-12 出版日期:2016-12-15
通信作者: 吴妹英
基金资助:
十二五传染病防治国家科技重大专项(No. 2013ZX10003008-003-001); 2014年苏州市临床重点病种诊疗技术专项项目(No. LCZX201314); 2014年江苏省预防医学会科研课题(No. Y2013023); 2015年苏州市临床重点病种诊疗技术专项项目(No. LCZX201414); 苏州市卫生局科教兴卫青年科技项目(No. KJXW2013033)

Efficiency of interferon-gamma release assay, anti-Mycobacterium tuberculosis and the combination in the diagnosis of tuberculosis

Xinghua Shen¹, Xiaolong Zhang², Peijun Tang¹, Xuefeng Wang³, Ping Xu¹, Xingnian Chen¹, Wei Tang¹, Meiying Wu¹^,^†()

^1. Department of Tuberculosis, The Fifth Affiliate Infectious Hospital of Soochow University, Suzhou 215007, China
^2. Department of Tubercosis Control, Suzhou Center For Diseases Prevention and Control, Suzhou 215007, China
^3. Department of Biochemistry and Molecular Biology, Soochow University, Suzhou 215123, China.

Received:2015-11-12 Published:2016-12-15
Corresponding author: Meiying Wu

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沈兴华, 张晓龙, 唐佩军, 王雪峰, 胥萍, 陈兴年, 汤伟, 吴妹英. 运用ROC曲线对γ-干扰素释放试验、抗-结核分枝杆菌及其组合在涂阴肺结核诊断中的效能分析[J]. 中华实验和临床感染病杂志(电子版), 2016, 10(06): 680-684.

Xinghua Shen, Xiaolong Zhang, Peijun Tang, Xuefeng Wang, Ping Xu, Xingnian Chen, Wei Tang, Meiying Wu. Efficiency of interferon-gamma release assay, anti-Mycobacterium tuberculosis and the combination in the diagnosis of tuberculosis[J]. Chinese Journal of Experimental and Clinical Infectious Diseases(Electronic Edition), 2016, 10(06): 680-684.

目的

探讨γ-干扰素释放试验（IGRA）、抗-结核分枝杆菌及其组合在肺结核诊断中的应用价值。

方法

回顾性调查苏州大学附属传染病医院结核病科于2013年6月至2014年12月收治的符合要求、资料完整的疑似肺结核病例共512例，采用IGRA试剂盒检测其血浆γ-干扰素含量，同时应用蛋白芯片识别仪检测其结核分枝杆菌蛋白16 kDa和38 kDa以及抗-脂阿拉伯甘露糖（Lam）含量，应用ELISA检测抗-结核分枝杆菌（TBAb），并将5种检测结果进行平行分析。

结果

在涂阴肺结核的单一检测指标中，IGRA的AUC最大，诊断效能最好。在各项指标联合检测中，二联组合16 kD + IGRA和三联组合IGG + 16 kD + IGRA较好，且两种组合的检验效能差异无统计学意义（Z = 1.622、P = 1.107），AUC分别为0.694和0.667，灵敏度分别为82%和96%，特异度分别为57%和36%。

结论

多项检测指标联合较单一指标检测能够提高涂阴肺结核诊断的灵敏度。16 kD + IGRA和IGG +16 kD + IGRA为IGRA、抗-分枝杆菌在涂阴肺结核诊断中的最优组合。

关键词: γ-干扰素释放试验, 结核分枝杆菌, 蛋白芯片, 抗体, 诊断

Objective

To investigate the potential value of interferon-gamma release assay (IGRA) and detection of anti-Mycobacterium tuberculosis (MTB) in the diagnosis of tuberculosis.

Methods

Data of 512 cases with suspected tuberculosis diagnosed from June 2013 to December 2014 in Department of Tuberculosis, the Fifth Affiliated Infectious Hosptital of Soochow University were analyzed, retrospectively. The concentration of interferon-gamma in blood plasma were detected by the IGRA kit. The concentration of anti-MTB-16 kD, anti-MTB-38 kD and anti-lipoarabinomannan (Lam) were detected by protein chip recognition instrument. The level of anti-tuberculosis (TBAb) was analyzed by ELISA method. The accuracy of diagnosis of tuberculosis based on single measurement or combination of them were evaluated through parallel comparison.

Results

For the cases with smear negative pulmonary tuberculosis, AUC of IGRA was the largest, indicating the best diagnostic accuracy. When combined with these indicators, a duplex combination of 16 kD + IGRA and a triple combination of IGG + 16 kD + IGRA showed better accuracy, but with no significant difference between the two combinations (Z = 1.622, P = 1.107). The AUC, sensitivity and specificity values of combination of 16 kD + IGRA were 0.694, 82% and 57%, respectively. The AUC, sensitivity and specificity values of combination of IGG + 16 kD + IGRA were 0.667, 96% and 36%, respectively.

Conclusions

Comparing with the single parameter, the combined multiple parameters may improve the sensitivity of diagnosis in smear negative pulmonary tuberculosis. The significant combinations of parameters in diagnosing smear negative pulmonary tuberculosis are 16 kD + IGRA and IGG + 16 kD + IGRA.

Key words: Interferon-gamma release assay, Mycobacterium tuberculosis, Protein chip, Antibody, Diagnosis

表1 各项检测指标在涂阴肺结核与肺部非结核患者中的阳性率

检测指标	涂阴肺结核组（n = 195）		肺部非结核疾病组（n = 317）		χ ²值	P值
检测指标	阳性数	阳性率（%）	阳性数	阳性率（%）
16 kD	9	4.6	8	2.5	1.646	0.200
38 kD	89	45.6	94	29.7	13.437	< 0.001
IGG	138	70.8	143	45.1	32.101	< 0.001
IGRA	160	82.1	133	42.0	79.294	< 0.001
Lam	95	48.7	101	31.9	14.520	< 0.001

表1 各项检测指标在涂阴肺结核与肺部非结核患者中的阳性率

检测指标	涂阴肺结核组（n = 195）		肺部非结核疾病组（n = 317）		χ ²值	P值
检测指标	阳性数	阳性率（%）	阳性数	阳性率（%）
16 kD	9	4.6	8	2.5	1.646	0.200
38 kD	89	45.6	94	29.7	13.437	< 0.001
IGG	138	70.8	143	45.1	32.101	< 0.001
IGRA	160	82.1	133	42.0	79.294	< 0.001
Lam	95	48.7	101	31.9	14.520	< 0.001

图1 单一检测指标ROC曲线

图2 二联检测指标ROC曲线

图3 三联检测指标ROC曲线

图4 四联及五联检测指标ROC曲线

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