MiniDock MTB Test用于结核病快速诊断的效能评价

doi:10.19982/j.issn.1000-6621.20250022

中国防痨杂志 ›› 2025, Vol. 47 ›› Issue (5): 577-581.doi: 10.19982/j.issn.1000-6621.20250022

MiniDock MTB Test用于结核病快速诊断的效能评价

巫株华¹, 王永², 赖晓宇¹, 纪丽微³, 陈蕊明³, 吕纯芳⁴, 徐镠粤¹, 郭卉欣¹, 陈瑜晖¹, 梁鸿迪¹, 刘盛元⁴(), 钟新光²(), 陈珣珣¹()

¹广东省结核病控制中心,广州 510632
²广东省东莞市第六人民医院,东莞 523008
³广东省汕头市结核病防治所,汕头 515031
⁴广东省深圳市南山区慢性病防治院,深圳 518054

收稿日期:2025-01-15 出版日期:2025-05-10 发布日期:2025-04-29
通信作者: 陈珣珣,Email: grace_chen514@163.com;钟新光,Email: zxgcdc@qq.com;刘盛元,Email: jfk@sznsmby.com
基金资助:
广东省科技计划项目(2021B1212030003);广东省感染性疾病(结核病)临床医学研究中心(2020B1111170014)

Evaluation of the diagnostic performance of the MiniDock MTB Test for rapid tuberculosis detection

Wu Zhuhua¹, Wang Yong², Lai Xiaoyu¹, Ji Liwei³, Chen Ruiming³, LYU Chunfang⁴, Xu Liuyue¹, Guo Huixin¹, Chen Yuhui¹, Liang Hongdi¹, Liu Shengyuan⁴(), Zhong Xinguang²(), Chen Xunxun¹()

¹Center for Tuberculosis Control of Guangdong Province, Guangzhou 510632, China
²Dongguan Sixth People’s Hospital, Guangdong Province, Dongguan 523008, China
³Shantou Institute of Tuberculosis Prevention and Control, Guangdong Province, Shantou 515031, China
⁴Shenzhen Nanshan Center for Chronic Disease Control, Guangdong Province, Shenzhen 518054, China

Received:2025-01-15 Online:2025-05-10 Published:2025-04-29
Contact: Chen Xunxun, Email: grace_chen514@163.com; Zhong Xinguang, Email: zxgcdc@qq.com; Liu Shengyuan, Email: jfk@sznsmby.com
Supported by:
Guangdong Science and Technology Plan Project(2021B1212030003);Guangdong Provincial Clinical Research Center for Tuberculosis(2020B1111170014)

摘要/Abstract

摘要：

【摘要】 目的: 评估MiniDock MTB Test(简称“MiniDock”)用于结核病快速诊断的价值。方法: 采用前瞻性研究方法,连续纳入2024年5—8月于东莞市第六人民医院、汕头市结核病防治所及深圳市南山区慢性病防治院接受治疗的疑似肺结核患者作为研究对象。收集患者临床信息,由实验室工作人员对纳入患者送检痰样本进行痰涂片抗酸杆菌染色镜检、固体培养、GeneXpert MTB/RIF(简称“Xpert”) 和MiniDock检测。结果: 最终纳入213例疑似肺结核患者,痰涂片抗酸杆菌染色镜检阳性率为22.07%(47/213),固体培养阳性率为 36.62%(78/213),Xpert检测阳性率为 32.86%(70/213),MiniDock检测阳性率为36.62%(78/213)。以临床诊断结果为参照标准,MiniDock检测敏感度和特异度分别为 47.24%(77/163)和 98.00%(49/50),Xpert检测敏感度和特异度分别为42.94%(70/163)和 100.00%(50/50)。以培养结果为参照标准,MiniDock检测的敏感度和特异度分别为84.62%(66/78)和 91.11%(123/135),Xpert 检测的敏感度和特异度分别为78.21%(61/78)和93.33%(126/135)。一致性分析显示:MiniDock和Xpert 两种检测方法具有较高的一致性(Kappa=0.88)。结论: MiniDock在结核病的诊断中展现了良好的敏感度和特异度,并且与Xpert检测结果具有较高的一致性。

关键词: 分枝杆菌,结核, 核酸扩增技术, 诊断,鉴别, 对比研究

Abstract:

Objective: To assess the diagnostic performance of the MiniDock MTB Test (hereafter referred to as “MiniDock”) for the rapid detection of tuberculosis (TB). Methods: A prospective study was conducted at three clinical sites in Guangdong Province—Dongguan Sixth People’s Hospital, Shantou Institute of Tuberculosis Prevention and Control, and Shenzhen Nanshan Center for Chronic Disease Control. Between May and August 2024, consecutive patients with suspected pulmonary TB who met the inclusion criteria were enrolled. Relevant clinical data were collected. Sputum specimens were subjected to Ziehl-Neelsen smear microscopy, solid culture on L?wenstein-Jensen medium, GeneXpert MTB/RIF (Xpert), and MiniDock testing, all performed by trained laboratory personnel. Results: A total of 213 patients with suspected pulmonary TB were enrolled. The positivity rates for smear microscopy, solid culture on L?wenstein-Jensen medium, Xpert, and MiniDock were 22.07% (47/213), 36.62% (78/213), 32.86% (70/213), and 36.62% (78/213), respectively. When clinical diagnosis was used as the reference standard, MiniDock achieved a sensitivity of 47.24% (77/163) and specificity of 98.00% (49/50), while Xpert showed a sensitivity of 42.94% (70/163) and specificity of 100.00% (50/50). Using culture as the reference, MiniDock yielded a sensitivity of 84.62% (66/78) and specificity of 91.11% (123/135), whereas Xpert demonstrated a sensitivity of 78.21% (61/78) and specificity of 93.33% (126/135). Agreement analysis between the two methods indicated a high level of concordance, with a Kappa coefficient of 0.88. Conclusion: The MiniDock MTB Test demonstrated robust diagnostic performance, with high sensitivity and specificity for TB detection, and showed strong concordance with the results of the Xpert assay.

Key words: Mycobacterium tuberculosis, Nucleic acid amplification techniques, Diagnosis, differential, Comparative study

中图分类号:

巫株华, 王永, 赖晓宇, 纪丽微, 陈蕊明, 吕纯芳, 徐镠粤, 郭卉欣, 陈瑜晖, 梁鸿迪, 刘盛元, 钟新光, 陈珣珣. MiniDock MTB Test用于结核病快速诊断的效能评价[J]. 中国防痨杂志, 2025, 47(5): 577-581. doi: 10.19982/j.issn.1000-6621.20250022

Wu Zhuhua, Wang Yong, Lai Xiaoyu, Ji Liwei, Chen Ruiming, LYU Chunfang, Xu Liuyue, Guo Huixin, Chen Yuhui, Liang Hongdi, Liu Shengyuan, Zhong Xinguang, Chen Xunxun. Evaluation of the diagnostic performance of the MiniDock MTB Test for rapid tuberculosis detection[J]. Chinese Journal of Antituberculosis, 2025, 47(5): 577-581. doi: 10.19982/j.issn.1000-6621.20250022

图/表 2

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检测方法	临床诊断(例)		合计 (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)
检测方法	结核	非结核	合计 (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)
MiniDock				47.24 (39.57~54.91)	98.00 (94.08~100.00)	98.72 (96.20~100.00)	36.30 (28.16~44.44)
阳性	77	1	78
阴性	86	49	135
合计	163	50	213
Xpert				42.94 (35.52~50.36)	100.00 (100.00~100.00)	100.00 (100.00~100.00)	34.97 (27.04~42.90)
阳性	70	0	70
阴性	93	50	143
合计	163	50	213
抗酸杆菌染色涂片				28.83 (22.20~35.46)	100.00 (100.00~100.00)	100.00 (100.00~100.00)	30.12 (22.89~37.35)
阳性	47	0	47
阴性	116	50	166
合计	163	50	213
固体培养				47.85 (40.14~55.56)	100.00 (100.00~100.00)	100.00 (100.00~100.00)	37.04 (28.82~45.26)
阳性	78	0	78
阴性	85	50	135
合计	163	50	213

检测方法	痰培养(例)		合计 (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)
检测方法	阳性	阴性	合计 (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)
MiniDock				84.62 (75.83~90.65)	91.11 (85.57~94.64)	84.62 (75.83~90.65)	91.11 (85.57~94.64)
阳性	66	12	78
阴性	12	123	135
合计	78	135	213
Xpert				78.21 (68.37~85.92)	93.33 (88.33~96.18)	87.14 (78.43~92.54)	88.11 (82.19~92.01)
阳性	61	9	70
阴性	17	126	143
合计	78	135	213

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MiniDock MTB Test用于结核病快速诊断的效能评价

Evaluation of the diagnostic performance of the MiniDock MTB Test for rapid tuberculosis detection

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