不同实验室检测技术在肺结核诊断中的应用价值研究

doi:10.20199/j.issn.1672-2302.2024.05.010

摘要/Abstract

摘要：

目的分析不同实验室检测技术在肺结核诊断中的应用价值，为不同检测技术在临床诊治中的应用提供依据。方法选择2023年1—8月在安徽省胸科医院就诊的疑似肺结核患者，采集痰标本进行抗酸染色涂片、分枝杆菌分离培养以及结核分枝杆菌DNA检测（TB-DNA）、RNA检测（TB-RNA）和GeneXpert MTB/RIF检测，采集血液标本进行结核感染T细胞斑点试验（TSPOT-TB）和结核分枝杆菌抗体（TB-Ab）检测。比较7种检测技术单独及联合检测的灵敏度、特异度、阳性预测值、阴性预测值和约登指数，绘制受试者工作特征曲线（receiver operating characteristic curve, ROC）并计算ROC下面积（area under the curve, AUC）。结果共有191例疑似肺结核患者纳入本研究。7种检测技术单独应用时，TSPOT-TB检测技术的灵敏度（74.17%）、阴性预测值（63.95%）和约登指数（0.516 3）最高，GeneXpert MTB/RIF检测技术的特异度（100.00%）和阳性预测值（100.00%）最高。联合应用时，TSPOT-TB、TB-Ab联合检测的灵敏度最高（91.67%），TB-DNA、TB-RNA和GeneXpert MTB/RIF联合检测的特异度（94.37%）、阳性预测值（94.44%）、阴性预测值（94.37%）和约登指数（0.510 4）最高。单独应用时，TSPOT-TB检测技术的AUC最高（0.758），联合应用时，TB-DNA、TB-RNA和GeneXpert MTB/RIF联合检测的AUC最高（0.755）。结论 7种实验室检测技术在肺结核诊断中均有效，其中TSPOT-TB检测技术的特异度、灵敏度和约登指数均较高。临床上可根据自身情况单独或者联合使用以达到最佳检测效果。

关键词: 肺结核, 实验室检测, 灵敏度, 特异度

Abstract:

Objective To analyze the value of different laboratory test technologies in the diagnosis of pulmonary tuberculosis so as to provide a basis for application of different detection technologies in clinical diagnosis and treatment of this infection. Methods Suspected tuberculosis patients who received treatment at Anhui Provincial Chest Hospital from January to August 2023 were selected, sputum specimens were collected for acid-fast bacilli smear, isolation culture, Mycobacterium tuberculosis DNA (TB-DNA), RNA (TB-RNA) and GeneXpert MTB/RIF detection. Blood specimens were harvested for TSPOT-TB and TB-Ab detection. The sensitivity, specificity, positive predictive value, negative predictive value and Youden index of the seven technologies were compared, and receiver operating characteristic curve (ROC) was drawn to calculate the area under the curve (AUC). Results A total of 191 suspected tuberculosis patients were included in this study. The sensitivity (74.17%), negative predictive value (63.95%) and Youden index (0.516 3) of TSPOT-TB were the highest when the seven technologies were separately used, and the GeneXpert MTB/RIF assay had the highest specificity (100.00%) and positive predictive value (100.00%). Combined use of TSPOT-TB and TB-Ab led the highest sensitivity (91.67%), and the specificity (94.37%), positive predictive value (94.44%), negative predictive value (94.37%) and Youden index (0.510 4) were the highest when TB-DNA, TB-RNA and GeneXpert MTB/RIF were jointly detected. TSPOT-TB had the highest AUC (0.758) when used alone, TB-DNA, TB-RNA and GeneXpert MTB/RIF assays had the highest AUC (0.755) when used in combination. Conclusion All the 7 laboratory technologies are effective in the diagnosis of pulmonary tuberculosis, yet TSPOT-TB produces the highest specificity, sensitivity and Youden index. In clinical settings, either of the single test or combined tests can be optional to achieve the best detection effect.

Key words: Pulmonary tuberculosis, Laboratory detection, Sensitivity, Specificity

中图分类号:

R521，R44

杨静, 陈叶昕, 夏广秀, 林雨虹, 李军, 徐东芳, 李跃, 丁运生, 包训迪. 不同实验室检测技术在肺结核诊断中的应用价值研究[J]. 热带病与寄生虫学, 2024, 22(5): 306-310.

YANG Jing, CHEN Yexin, XIA Guangxiu, LIN Yuhong, LI Jun, XU Dongfang, LI Yue, DING Yunsheng, BAO Xundi. The application value of different laboratory detection technologies in the diagnosis of lung tuberculosis[J]. Journal of Tropical Diseases and Parasitology, 2024, 22(5): 306-310.

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参考文献 18

[1]	World Health Organization. Global tuberculosis report 2023[R/OL].[2024-05-10]. https://www.who.int/teams/global-tuberculosis-programme/tb-reports/global-tuberculosis-report-2023.
[2]	中华人民共和国国家卫生和计划生育委员会. 肺结核诊断:WS 288—2017[S/OL].(2017-11-09)[2024-05-10]. http://www.nhc.gov.cn/ewebeditor/uploadfile/2017/12/2017121215482389.pdf.
[3]	李静, 吴哲渊, 杨景卉, 等. 恒温扩增荧光检测法检测结核分枝杆菌复合群的应用价值[J]. 中国防痨杂志, 2022, 44(11):1167-1173.
[4]	余琴, 刘海灿, 赵爱兰, 等. 基层实验室肺结核检测方法的优化组合[J]. 实用预防医学, 2023, 30(3):365-368.
[5]	赵雁林, 逄宇. 结核病实验室检验规程[M]. 北京: 人民卫生出版社, 2015.
[6]	李雪, 徐彩红, 魏松庭, 等. 2011—2015年全国结核病实验室能力建设现状分析[J]. 中国公共卫生管理, 2019, 35(4):441-444.
[7]	Suárez I, Fünger SM, Kröger S, et al. The diagnosis and treatment of tuberculosis[J]. Dtsch Arztebl Int, 2019, 116(43):729-735. doi: 10.3238/arztebl.2019.0729 pmid: 31755407
[8]	Ortiz-Brizuela E, Menzies D, Behr MA. Testing and treating Mycobacterium tuberculosis infection[J]. Med Clin North Am, 2022, 106(6):929-947.
[9]	付亮, 邓国防. 实验室检测技术在肺结核活动性判断中的应用进展[J]. 中国防痨杂志, 2020, 42(6):626-629.
[10]	余琴, 林楠, 俞南, 等. 2013—2021年北京市朝阳区结核病门诊实验室痰检结果分析[J]. 疾病监测, 2024, 34(2):178-183.
[11]	董思佳. 五种结核病实验室检测方法在医疗机构应用的检测性能及成本分析[D]. 沈阳: 中国医科大学, 2022.
[12]	邹远妩, 李静, 王彪, 等. 结核分枝杆菌RNA恒温扩增实时荧光检测技术检测肺泡灌洗液诊断肺结核的价值[J]. 中国防痨杂志, 2023, 45(4):434-436.
[13]	陈江燕, 王霖, 马志强, 等. 结核分枝杆菌DNA及RNA检测在结核病中的诊断价值[J]. 云南医药, 2023, 44(2):26-29.
[14]	中国医疗保健国际交流促进会临床微生物与感染分会, 中华医学会检验医学分会临床微生物学组. 综合医院结核分枝杆菌感染实验室检查共识[J]. 中华检验医学杂志, 2022, 45(4):343-353.
[15]	Goletti D, Delogu G, Matteelli A, et al. The role of IGRA in the diagnosis of tuberculosis infection, differentiating from active tuberculosis, and decision making for initiating treatment or preventive therapy of tuberculosis infection[J]. Int J Infect Dis,2022,124:S12-S19.
[16]	Maekura R, Kitada S, Osada-Oka M, et al. Serum antibody profiles in individuals with latent Mycobacterium tuberculosis infection[J]. Microbiol Immunol, 2019, 63(3/4):130-138.
[17]	Engel N, Ochodo EA, Karanja PW, et al. Rapid molecular tests for tuberculosis and tuberculosis drug resistance: a qualitative evidence synthesis of recipient and provider views[J]. Cochrane Database Syst Rev, 2022,4:CD014877.
[18]	Park M, Kon OM. Use of Xpert MTB/RIF and Xpert Ultra in extrapulmonary tuberculosis[J]. Expert Rev Anti Infect Ther, 2021, 19(1):65-77.

检测技术	灵敏度（%）	特异度（%）	阳性预测值（%）	阴性预测值（%）	约登指数	AUC（95%CI）值	P值
单一检测
TSPOT-TB	74.17	77.46	84.76	63.95	0.516 3	0.758（0.686，0.830）	<0.01
TB-Ab	55.83	63.38	72.43	45.92	0.192 1	0.596（0.513，0.679）	<0.05
抗酸染色涂片	17.50	97.18	91.30	41.07	0.146 8	0.573（0.492，0.655）	>0.05
分枝杆菌分离培养	55.00	85.92	86.84	53.04	0.409 2	0.705（0.630，0.779）	<0.01
TB-DNA	38.33	95.77	93.88	47.89	0.341 0	0.671（0.595，0.746）	<0.01
TB-RNA	30.83	98.59	97.37	45.75	0.294 2	0.647（0.571，0.724）	<0.01
GeneXpert MTB/RIF	49.17	100.00	100.00	53.79	0.491 7	0.746（0.678，0.813）	<0.01
联合检测
TSPOT-TB+TB-Ab	91.67	47.89	74.83	77.27	0.395 6	0.698（0.616，0.780）	<0.01
抗酸染色涂片+分枝杆菌分离培养	56.67	85.92	87.18	53.98	0.425 9	0.713（0.639，0.787）	<0.01
TB-DNA+TB-RNA+Gene-Xpert MTB/RIF	56.67	94.37	94.44	56.30	0.510 4	0.755（0.687，0.823）	<0.01