Genewise-MTBC系统快速检测结核分枝杆菌复合群的性能评估

doi:10.19982/j.issn.1000-6621.20260027

中国防痨杂志 ›› 2026, Vol. 48 ›› Issue (7): 985-991.doi: 10.19982/j.issn.1000-6621.20260027

Genewise-MTBC系统快速检测结核分枝杆菌复合群的性能评估

王聪丽, 王昊然, 黄海荣, 姜广路()

北京市结核病胸部肿瘤研究所/首都医科大学附属北京胸科医院国家结核病临床实验室/耐药结核病研究北京市重点实验室, 北京 101149

收稿日期:2026-01-16 出版日期:2026-07-10 发布日期:2026-07-02
通信作者: 姜广路,Email:guanglu0725@126.com
基金资助:
北京市卫生健康委员会高层次公共卫生人才(G2023-2-002);北京市科技新星计划(20230484411)

Performance evaluation of the Genewise-MTBC System in the rapid detection of the Mycobacterium tuberculosis complex

Wang Congli, Wang Haoran, Huang Hairong, Jiang Guanglu()

National Clinical Laboratory on Tuberculosis, Beijing Key Laboratory on Drug-resistant Tuberculosis Research, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor Institute, Beijing 101149, China

Received:2026-01-16 Online:2026-07-10 Published:2026-07-02
Contact: Jiang Guanglu,Email:guanglu0725@126.com
Supported by:
Beijing Municipal Health Commission High-Level Public Health Talent(G2023-2-002);Beijing Science and Technology New Star Program(20230484411)

摘要/Abstract

摘要：

目的: 初步评价Genewise-MTBC系统对结核分枝杆菌复合群的检测性能。方法: 使用连续稀释的结核分枝杆菌和牛分枝杆菌的模式菌株来确定Genewise-MTBC的检测限。以17株非结核分枝杆菌和其他14种病原微生物的模式菌株或分离株与痰液混合,测试该系统特异度。同时,将潜在的干扰物质在其最高生理浓度下与痰液混合,以测试系统的抗干扰能力。此外,对71份临床标本进行了Genewise-MTBC检测,与GeneXpert MTB/RIF检测平行进行,以临床诊断为标准,评估其临床可行性。结果: Genewise-MTBC检测系统针对结核分枝杆菌复合群的最低检出限为18CFU/ml。同时,该检测系统与17种非结核分枝杆菌和14种其他病原微生物均无交叉反应。对71份临床标本检测,以临床诊断为金标准,Genewise-MTBC系统和GeneXpert MTB/RIF检测的敏感度分别为61.11%(33/54)和57.41%(31/54),特异度分别为94.12%(16/17)和100.00%(17/17),阳性预测值分别为97.06%(33/34)和100.00%(31/31),阴性预测值分别为43.24%(16/37)和43.50%(17/40)。结论: Genewise-MTBC系统具有较高的敏感度、特异度、稳定性和抗干扰性,值得在未来进行大规模临床评价。

关键词: 分枝杆菌, 结核, 诊断, 鉴别, 分子诊断技术

Abstract:

Objective: To preliminarily evaluate the performance of the Genewise-MTBC system for the Mycobacterium tuberculosis complex detection. Methods: Serially diluted type strains of M.tuberculosis and M.bovis were used to identify the limit of detection (LOD) of Genewise-MTBC. A total of 17 strains of nontuberculous mycobacteria (NTM) and 14 other pathogenic microorganisms were included to test its specificity. Meanwhile, potential interfering substances at their highest physiological concentrations were mixed with sputum to test the anti-interference ability of the system. Moreover, based on clinical diagnosis, Genewise-MTBC tests were performed on 71 clinical specimens in parallel with GeneXpert MTB/RIF assay to evaluate the clinical feasibility. Results: The LOD of Genewise-MTBC was defined as 18 CFU/ml for MTBC detection. Meanwhile, the test had no cross-reactivity with 17 NTM and 14 other respiratory pathogens. With clinical diagnosis as the gold standard, for the 71 clinical specimens, the sensitivities of Genewise-MTBC and GeneXpert MTB/RIF were 61.11% (33/54) and 57.41% (31/54), respectively; the specificities were 94.12% (16/17) and 100.00% (17/17), respectively; the positive predictive values were 97.06% (33/34) and 100.00% (31/31), respectively; and the negative predictive values were 43.24% (16/37) and 43.50% (17/40), respectively. Conclusion: The Genewise-MTBC system possesses high sensitivity, specificity, stability and anti-interference capability, which is worthy of a large-scale clinical evaluation in the future.

Key words: Mycobacterium tuberculosis, Diagnosis, differential, Molecular diagnostic techniques

中图分类号:

王聪丽, 王昊然, 黄海荣, 姜广路. Genewise-MTBC系统快速检测结核分枝杆菌复合群的性能评估[J]. 中国防痨杂志, 2026, 48(7): 985-991. doi: 10.19982/j.issn.1000-6621.20260027

Wang Congli, Wang Haoran, Huang Hairong, Jiang Guanglu. Performance evaluation of the Genewise-MTBC System in the rapid detection of the Mycobacterium tuberculosis complex[J]. Chinese Journal of Antituberculosis, 2026, 48(7): 985-991. doi: 10.19982/j.issn.1000-6621.20260027

图/表 5

图1

表1

图2

表2

表3

参考文献 13

[1]	World Health Organization. Global tuberculosis report 2025[R]. Geneva: World Health Organization, 2025.
[2]	中华人民共和国国家卫生和计划生育委员会. WS 288—2017肺结核诊断[S].2017-11-09.
[3]	Ankrah A O, Glaudemans A W J M, Maes A, et al. Tuberculosis[J]. Semin Nucl Med, 2018, 48(2): 108-130. doi:10.1053/j.semnuclmed.2017.10.005. pmid: 29452616
[4]	蒋莎莉, 梁伟军, 朱德茂, 等. 不同检测方法对肺结核患者肺泡灌洗液中结核杆菌的诊断价值[J]. 中南大学学报(医学版), 2017, 42(6): 647-651. doi:10.11817/j.issn.1672-7347.2017.06.008.
[5]	Tjale M A, Ombinda-Lemboumba S, Maphanga C, et al. TB diagnostic insights, progress made on point of care diagnostics and bioinformatics as an additional tool for improvement[J]. Indian J Tuberc, 2023, 70(4): 468-474. doi:10.1016/j.ijtb.2023.03.023. pmid: 37968053
[6]	Wallis R S, Pai M, Menzies D, et al. Biomarkers and diagnostics for tuberculosis: progress, needs, and translation into practice[J]. Lancet, 2010, 375(9729): 1920-1937. doi:10.1016/S0140-6736(10)60359-5. pmid: 20488517
[7]	Abebe G, Paasch F, Apers L, et al. Tuberculosis drug resistance testing by molecular methods: opportunities and challenges in resource limited settings[J]. J Microbiol Methods, 2011, 84(2): 155-160. doi:10.1016/j.mimet.2010.11.014. pmid: 21129417
[8]	Singh P, Saket V K, Kachhi R. Diagnosis of TB: From conventional to modern molecular protocols[J]. Front Biosci (Elite Ed), 2019, 11(1): 38-60. doi:10.2741/E845. pmid: 30468637
[9]	Boehme C C, Nabeta P, Hillemann D, et al. Rapid molecular detection of tuberculosis and rifampin resistance[J]. N Engl J Med, 2010, 363(11): 1005-1015. doi:10.1056/NEJMoa0907847.
[10]	Longo M C, Berninger M S, Hartley J L. Use of uracil DNA glycosylase to control carry-over contamination in polymerase chain reactions[J]. Gene, 1990, 93(1): 125-128. doi:10.1128/spectrum.00949-22.
[11]	国家药品监督管理局医疗器械技术审评中心. 结核分枝杆菌复合群核酸检测试剂注册审查指导原则(2025年修订版)(2026年第6号)[S]. https://www.cmde.org.cn/flfg/zdyz/zdyzwbk/20260311141548128.html
[12]	Dorman S E, Schumacher S G, Alland D, et al. Xpert MTB/RIF Ultra for detection of Mycobacterium tuberculosis and rifampicin resistance: a prospective multicentre diagnostic accuracy study[J]. Lancet Infect Dis, 2018, 18(1): 76-84. doi:10.1016/S1473-3099(17)30691-6. pmid: 29198911
[13]	Zhang Z, Du J, Liu T, et al. EasyNAT MTC Assay: A Simple, Rapid, and Low Cost Cross-Priming Amplification Method for Detection of Mycobacterium Tuberculosis Suitable for Point-of-Care Testing[J]. Emerg Microbes Infect, 2021, 10(1): 1530-1535. doi:10.1080/22221751.2021.1959271.

物质	活性成分	检测浓度	相对对照组测试Ct差值
黏蛋白	纯化黏蛋白	2mg/ml	0.42
人血液	/	20%	-0.52
人细胞	HELA 细胞	10⁶ 个细胞/ml	0.85
抗结核药物	异烟肼	10μg/ml	0.58
	利福平	25μg/ml	-0.23
	乙胺丁醇	5μg/ml	-0.33
	吡嗪酰胺	50μg/ml	-0.58
	链霉素	25μg/ml	-0.51
抗菌药物	卡那霉素	50μg/ml	0.64
	左氧氟沙星	500μg/ml	-0.24
	阿莫西林	500μg/ml	-0.43
抗病毒药物	扎那米韦	100μg/ml	-0.26
鼻腔喷雾剂或滴鼻剂	羟甲唑啉	15%	0.02
	含防腐剂的氯化钠溶液	15%	0.37
抗生素、鼻用软膏	莫匹罗星	500μg/ml	-0.31
抗休克激素药物	肾上腺素	125μg/ml	-0.14
鼻用皮肤类固醇	地塞米松	0.5mg/ml	-0.91
	布地奈德	320μg/ml	0.37
	倍氯米松	50μg/ml	-0.27
	氟尼缩松	250μg/ml	0.48
	曲安西龙	500μg/ml	0.45
	莫美他松	100μg/ml	-0.40
	氟替卡松	5μg/ml	-0.20

样本	批内						批间
	第一批		第二批		第三批		批间
	$\bar{x}±s$	CV(%)	$\bar{x}±s$	CV(%)	$\bar{x}±s$	CV(%)	$\bar{x}±s$	CV(%)
中等阳性	35.01±0.82	2.34	34.83±0.87	2.49	35.26±0.87	2.47	35.03±0.86	2.47
弱阳性	35.96±0.89	2.48	36.12±0.82	2.28	35.94±0.71	1.99	36.01±0.81	2.25

[1]	乔晓博, 李静, 王宝千, 周伟东, 王飞, 张齐波, 李同霞. 肺泡灌洗液GeneXpert MTB/RIF、BACTEC MGIT 960联合外周血IGRA检测对病原学阴性肺结核的诊断价值[J]. 中国防痨杂志, 2026, 48(6): 874-881.
[2]	侯田勇, 任丽萍, 李静颖, 王建伟, 樊姝慧, 吴渊明, 王全红, 丁卫民. 支气管肺泡灌洗液分子生物学联合检测对涂阴肺结核患者的诊断价值[J]. 中国防痨杂志, 2026, 48(3): 329-334.
[3]	王珏, 姚瀚鑫, 孙雪娟, 冯丹, 吴秒一, 张铭锦, 马昕启. 结核病分子诊断技术的进展[J]. 中国防痨杂志, 2025, 47(S1): 366-371.
[4]	赖晓宇, 段鸿飞, 陈珣珣, 郭卉欣, 廖庆华, 陈茜, 梁丹. 结核性葡萄膜炎临床特征、诊断策略与分级标准研究进展[J]. 中国防痨杂志, 2025, 47(9): 1204-1211.
[5]	赵琰枫, 屠霞, 王嫩寒, 陈双双, 田丽丽, 樊瑞芳, 于兰, 李洁, 李传友, 代小伟. 三种检测方法在肺结核患者病原学阳性检出中的贡献分析[J]. 中国防痨杂志, 2025, 47(6): 701-707.
[6]	孙晓柯, 魏金星, 张春艳, 梁瑞霞, 史慧敏, 阮祥林, 段鸿飞. 纳米孔靶向测序技术对福尔马林固定石蜡包埋组织中肉芽肿性疾病的诊断价值[J]. 中国防痨杂志, 2025, 47(5): 582-588.
[7]	贾辉, 景辉, 凌晓洁, 王燕, 李学政. GeneXpert MTB/RIF Ultra检测痰液样本对新发肺结核的诊断价值[J]. 中国防痨杂志, 2025, 47(3): 298-304.
[8]	石玉如, 谷德健, 吴静, 刘婷, 秦令寒, 岳莉, 戚应杰. 靶向捕获测序技术和宏基因组二代测序技术检测肺泡灌洗液中结核分枝杆菌的诊断价值[J]. 中国防痨杂志, 2025, 47(3): 305-311.
[9]	严广璇, 王雪钰, 王宇津, 兰汀隆, 聂文娟. 宏基因组二代测序对疑似骨关节结核患者的诊断价值[J]. 中国防痨杂志, 2025, 47(2): 175-180.
[10]	王怡婷, 孟祥莉, 付茵, 曹晓龙, 郑惠文, 贺文从, 宋泽萱, 赵雁林. 宏基因组测序应用于结核病防治的研究进展[J]. 中国防痨杂志, 2024, 46(8): 976-981.
[11]	李静, 姜琦, 江渊, 沈鑫. PCR荧光探针技术对结核分枝杆菌复合群及利福平耐药性检测性能的评价[J]. 中国防痨杂志, 2024, 46(10): 1250-1258.
[12]	李晓迎, 方玉莲, 宁静, 徐勇胜. GeneXpert MTB/RIF粪便检测在儿童结核病中的研究进展[J]. 中国防痨杂志, 2024, 46(1): 119-123.
[13]	闫晓婧, 王庆枫, 杨扬, 初乃惠, 聂文娟. 支气管肺泡灌洗液纳米孔测序对涂片阴性肺结核诊断价值的验证性研究[J]. 中国防痨杂志, 2023, 45(5): 487-492.
[14]	李姗姗, 王玉峰, 舒薇, 逄宇. 结核病实验室诊断技术研发新进展[J]. 中国防痨杂志, 2023, 45(5): 446-453.
[15]	邹远妩, 李静, 王彪, 王卓, 屈少毅, 袁志敏, 仵倩红. 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.

Genewise-MTBC系统快速检测结核分枝杆菌复合群的性能评估

Performance evaluation of the Genewise-MTBC System in the rapid detection of the Mycobacterium tuberculosis complex

RichHTML

PDF (PC)

可视化

摘要/Abstract

引用本文

使用本文

图/表 5

参考文献 13

相关文章 15

编辑推荐

Metrics

本文评价

样本类型	患者类型	Genewise-MTBC系统		GeneXpert MTB/RIF
样本类型	患者类型	阳性	阴性	阳性	阴性
痰液	确诊结核病	13	0	13	0
	临床诊断结核病	1	4	1	4
	非结核病	0	2	0	2
支气管肺泡灌洗液	确诊结核病	11	0	11	0
	临床诊断结核病	3	16	1	18
	非结核病	1	8	0	9
胸腔积液	确诊结核病	5	0	5	0
	临床诊断结核病	0	1	0	1
	非结核病	0	6	0	6
	合计	34	37	31	40