InnowaveDX MTB/RIF对结核分枝杆菌复合群及利福平耐药检测性能的评估

doi:10.19982/j.issn.1000-6621.20230348

中国防痨杂志 ›› 2024, Vol. 46 ›› Issue (1): 70-74.doi: 10.19982/j.issn.1000-6621.20230348

InnowaveDX MTB/RIF对结核分枝杆菌复合群及利福平耐药检测性能的评估

刘梅, 吴霞, 古旭, 李娜娜, 张万敏, 张小可, 兰远波()

遵义医科大学附属医院结核病科,遵义 563000

收稿日期:2023-09-26 出版日期:2024-01-10 发布日期:2024-01-04
通信作者: 兰远波,Email:lybivy@163.com
基金资助:
贵州省科技计划项目(黔科合基础-ZK〔2023〕581);遵义市科技计划项目(遵市科合HZ〔2022〕254);贵州省卫生计生委科学技术基金(gzwjkj2018-024)

Evaluation of the performance of InnowaveDX MTB/RIF in detecting Mycobacterium tuberculosis complex and rifampicin resistance

Liu Mei, Wu Xia, Gu Xu, Li Nana, Zhang Wanmin, Zhang Xiaoke, Lan Yuanbo()

Tuberculosis Division of Respiratory and Critical Care Medicine, Affiliated Hospital of Zunyi Medical University, Zunyi 563000, China

Received:2023-09-26 Online:2024-01-10 Published:2024-01-04
Contact: Lan Yuanbo, Email: lybivy@163.com
Supported by:
Guizhou Provincial Science and Technology Foundation (ZK〔2023〕581);Zunyi Science and Technology Foundation(HZ〔2022〕254);Science and Technology Fund Project of Guizhou Provincial Health Commission(gzwjkj2018-024)

摘要/Abstract

摘要：

目的：评估InnowaveDX MTB/RIF(简称“InnowaveDX”)检测结核分枝杆菌复合群(Mycobacterium tuberculosis complex,MTBC)及MTB利福平耐药性的性能。方法：采用前瞻性研究方法,连续纳入2023年3月1日至6月30日遵义医科大学附属医院具有结核病相关体征/症状,或胸部X线检查结果提示疑似结核病的患者作为研究对象,共纳入104例。其中,93例诊断为结核病(包括68例经病原学阳性确诊,25例病原学阴性经临床诊断确诊),11例临床诊断为非结核病。收集研究对象的痰液、支气管肺泡灌洗液、尿液、淋巴结穿刺液、脑脊液、脓液及胸腔积液,行涂片抗酸杆菌染色镜检、培养、InnowaveDX和GeneXpert MTB/RIF(简称“Xpert”)检测,评价InnowaveDX 对结核病和MTB利福平耐药性的检测效能。结果：以病原学及临床诊断结果为参照,InnowaveDX检测结核病的敏感度、特异度、一致率、Kappa值分别为92.5%(86/93)、100.0%(11/11)、93.3%(97/104)、0.72;Xpert检测结核病的敏感度、特异度、一致率、Kappa值分别为93.6%(87/93)、100.0%(11/11)、94.2%(98/104)、0.75。InnowaveDX和Xpert检测痰标本阳性率均为91.5%(65/71),差异无统计学意义(χ²=0.000,P=1.000);检测其他类型标本(支气管肺泡灌洗液、尿液、淋巴结穿刺液、脑脊液、脓液及胸腔积液)阳性率分别为95.5%(21/22)和100.0%(22/22),差异无统计学意义(Fisher精确概率法,P=1.000)。以Xpert检测MTB利福平耐药性结果为参照,InnowaveDX检测MTB利福平耐药的敏感度为97.0%(32/33),特异度为92.2%(47/51),Kappa值为0.88。结论：InnowaveDX对于MTBC具有较好的检测效能,且适用于不同类型的标本,检测MTB利福平耐药性结果与Xpert一致性好。

关键词: 分枝杆菌,结核, 抗药性,细菌, 利福平, 诊断

Abstract:

Objective: To evaluate the performance of InnowaveDX MTB/RIF (InnowaveDX) in detecting Mycobacterium tuberculosis complex (MTBC) and MTB rifampicin resistance. Methods: Using prospective research methods, 104 consecutive patients with tuberculosis related signs/symptoms or suspected tuberculosis according to chest X-ray from March 1 to June 30, 2023 in the Affiliated Hospital of Zunyi Medical University were included as research objects. Among them, 93 cases were diagnosed as tuberculosis (68 cases diagnosed with positive etiology and 25 cases diagnosed with negative etiology), and 11 cases were diagnosed as non-tuberculosis. Sputum, bronchoalveolar lavage fluid, urine, lymph node puncture fluid, cerebrospinal fluid, pus and pleural effusion of the subjects were collected for smear acid fast bacilli staining microscopy, culture, InnowaveDX and GeneXpert MTB/RIF (Xpert) detections, and the detection efficiency of InnowaveDX for tuberculosis and MTB rifampicin resistance was evaluated. Results: Based on etiology and clinical diagnosis, the sensitivity, specificity, consistency and Kappa value of InnowaveDX in detecting tuberculosis were 92.5% (86/93), 100.0% (11/11), 93.3% (97/104) and 0.72 respectively; and those of Xpert were 93.6% (87/93), 100.0% (11/11), 94.2% (98/104) and 0.75, respectively. The positive rates of InnowaveDX and Xpert in detecting sputum samples were both 91.5% (65/71), and the difference was not statistically significant(χ²=0.000, P=1.000); the positive rates of detecting other types of specimens (bronchoalveolar lavage fluid, urine, lymph node puncture fluid, cerebrospinal fluid, pus, and pleural effusion) were 95.5% (21/22) and 100.0% (22/22), respectively, with no statistically significant difference (Fisher’s exact probability method, P=1.000). Based on the results of Xpert testing for MTB rifampicin resistance, the sensitivity of InnowaveDX testing for MTB rifampicin resistance was 97.0% (32/33), the specificity was 92.2% (47/51), and the Kappa value was 0.88. Conclusion: InnowaveDX has good detection efficiency for MTBC and is suitable for different types of specimens. And the results of detecting MTB rifampicin resistance are consistent with Xpert.

Key words: Mycobacterium tuberculosis, Drug resistance, bacterial, Rifampin, Diagnosis

中图分类号:

R52
R825.2

刘梅, 吴霞, 古旭, 李娜娜, 张万敏, 张小可, 兰远波. InnowaveDX MTB/RIF对结核分枝杆菌复合群及利福平耐药检测性能的评估[J]. 中国防痨杂志, 2024, 46(1): 70-74. doi: 10.19982/j.issn.1000-6621.20230348

Liu Mei, Wu Xia, Gu Xu, Li Nana, Zhang Wanmin, Zhang Xiaoke, Lan Yuanbo. Evaluation of the performance of InnowaveDX MTB/RIF in detecting Mycobacterium tuberculosis complex and rifampicin resistance[J]. Chinese Journal of Antituberculosis, 2024, 46(1): 70-74. doi: 10.19982/j.issn.1000-6621.20230348

图/表 2

参考文献 10

[1]	阮云洲, 张红伟, 李月华, 等. 综合医院引入GeneXpert MTB/RIF技术早期发现病原学阳性和耐药肺结核患者的效果分析. 中国防痨杂志, 2023, 45(11): 1072-1077. doi:10.19982/j.issn.1000-6621.20230313.
[2]	Kohli M, Schiller I, Dendukuri N, et al. Xpert MTB/RIF Ultra and Xpert MTB/RIF assays for extrapulmonary tuberculosis and rifampicin resistance in adults. Cochrane Database Syst Rev, 2021, 1(1): CD012768. doi:10.1002/14651858.CD012768.pub3.
[3]	Walzl G, McNerney R, du Plessis N, et al. Tuberculosis: advances and challenges in development of new diagnostics and biomarkers. Lancet Infect Dis, 2018, 18(7): e199 -e210. doi:10.1016/S1473-3099(18)30111-7.
[4]	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. 2017-11-09.
[5]	赵雁林, 逄宇. 结核病实验室检验规程. 北京: 人民卫生出版社, 2015.
[6]	梁晨, 唐神结. 临床结核病病原体分子生物学诊断年度进展2022. 中华结核和呼吸杂志, 2023, 46(2): 176-182. doi:10.3760/cma.j.cn112147-20221030-00857.
[7]	王少华, 郑丹薇, 朱岩坤, 等. 两种恒温扩增分子检测法与实时荧光定量核酸扩增法对肺结核诊断价值的比较.中华结核和呼吸杂志, 2018, 41(2): 105-110. doi:10.3760/cma.j.issn.1001-0939.2018.02.007.
[8]	王艳萍, 谭云洪, 李欣, 等. InnowaveDX MTB/RIF对结核分枝杆菌复合群及利福平耐药检测性能评估. 中华结核和呼吸杂志, 2023, 46(7):658-663. doi:10.3760/cma.j.cn112147-20221104-00877.
[9]	Zong K, Luo C, Zhou H, et al. Xpert MTB/RIF assay for the diagnosis of rifampicin resistance in different regions: a meta-analysis. BMC Microbiol, 2019, 19(1): 177. doi:10.1186/s12866-019-1516-5. pmid: 31382894
[10]	Tabriz NS, Skak K, Kassayeva LT, et al. Efficacy of the Xpert MTB/RIF Assay in Multidrug-Resistant Tuberculosis. Microb Drug Resist, 2020, 26(8): 997-1004. doi:10.1089/mdr.2019.0326. pmid: 32181685

检测方法	结核病 (例)^a	非结核病 (例)	敏感度 (%,95%CI)	特异度 (%,95%CI)	阳性预测值 (%,95%CI)	阴性预测值 (%,95%CI)	一致率 (%,95%CI)	Kappa值
InnowaveDX			92.5 (84.6~96.7)	100.0 (67.9~100.0)	100.0 (94.7~100.0)	61.1 (36.1~81.7)	93.3 (88.4~98.2)	0.72
结核病	86	0
非结核病	7	11
Xpert			93.6 (86.0~97.4)	100.0 (67.9~100.0)	100.0 (94.7~100.0)	64.7 (38.6~84.7)	94.2 (89.7~98.8)	0.75
结核病	87	0
非结核病	6	11

InnowaveDX 检测	Xpert检测利福平耐药情况		敏感度 (%,95%CI)	特异度 (%,95%CI)	阳性预测值 (%,95%CI)	阴性预测值 (%,95%CI)	一致率 (%,95%CI)	Kappa值
InnowaveDX 检测	耐药(份)	敏感(份)	敏感度 (%,95%CI)	特异度 (%,95%CI)	阳性预测值 (%,95%CI)	阴性预测值 (%,95%CI)	一致率 (%,95%CI)	Kappa值
利福平			97.0 (82.5~99.8)	92.2 (80.3~97.5)	88.9 (73.0~96.4)	97.9 (87.5~99.9)	94.1 (86.0~97.8)	0.88
耐药	32	4
敏感	1	47
合计	33	51

[1]	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.
[2]	张国钦, 魏文亮, 张志, 张玉华, 钟达, 张帆. 监狱羁押人群中两种结核分枝杆菌潜伏感染检测结果不一致原因及预防性治疗效果分析[J]. 中国防痨杂志, 2024, 46(1): 45-53.
[3]	贝呈, 李蒙, 高谦. 基于血液样本的转录标识物在结核病诊断中的研究进展[J]. 中国防痨杂志, 2023, 45(8): 801-807.
[4]	辛赫男, 高磊. 《世界卫生组织结核病整合指南模块3:诊断——结核感染检测》解读[J]. 中国防痨杂志, 2023, 45(7): 639-643.
[5]	曹兵生, 张更臣, 傅莉媛, 王金山. 超声引导下经皮穿刺活检在髋关节结核诊断中的应用价值[J]. 中国防痨杂志, 2023, 45(7): 669-672.
[6]	中国人民解放军总医院第八医学中心结核病医学部, 《中国防痨杂志》编辑委员会, 中国医疗保健国际交流促进会结核病防治分会. 浅表淋巴结结核的诊断与治疗专家共识[J]. 中国防痨杂志, 2023, 45(6): 531-542.
[7]	温立旻, 侯代伦. 肺结核合并肺癌影像学评估方法现状及进展[J]. 中国防痨杂志, 2023, 45(6): 620-624.
[8]	廖艺璇, 方创森, 李燕明. 加强结核病非定点医疗机构能力建设提高结核病诊断水平[J]. 中国防痨杂志, 2023, 45(5): 437-441.
[9]	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.
[10]	宋瑞雪, 魏荣荣, 董静, 贾红彦, 杜博平, 孙琦, 邢爱英, 李自慧, 朱传智, 张宗德, 潘丽萍. γ-干扰素诱导蛋白-10 mRNA检测技术对结核病辅助诊断的价值[J]. 中国防痨杂志, 2023, 45(5): 471-476.
[11]	李红娜, 毛昕, 徐碧宇, 吴晨阳, 董丽儒, 宋旭东. 常见原位病理染色技术诊断肺结核的临床价值研究[J]. 中国防痨杂志, 2023, 45(5): 477-482.
[12]	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.
[13]	陈华, 陈品儒, 李艳阳, 邓政先, 许柳清, 梁锋, 胡锦兴. 靶向高通量测序鉴定非结核分枝杆菌菌种的应用价值[J]. 中国防痨杂志, 2023, 45(4): 362-366.
[14]	朱玉梅, 夏子涵, 李金莉, 何慧珊, 王峰. 多色探针熔解曲线分析技术检测准广泛耐药肺结核的应用价值[J]. 中国防痨杂志, 2023, 45(4): 406-411.
[15]	周伟东, 张正冬, 林梅, 李同霞. 鸟-胞内分枝杆菌复合群脊柱疾病的诊断与治疗进展[J]. 中国防痨杂志, 2023, 45(4): 420-425.

InnowaveDX MTB/RIF对结核分枝杆菌复合群及利福平耐药检测性能的评估

Evaluation of the performance of InnowaveDX MTB/RIF in detecting Mycobacterium tuberculosis complex and rifampicin resistance

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