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

作　　者：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 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(Center for Tuberculosis Control of Guangdong Province,Guangzhou 510632,China;Dongguan Sixth People’s Hospital,Guangdong Province,Dongguan 523008,China;Shantou Institute of Tuberculosis Prevention and Control,Guangdong Province,Shantou 515031,China;Shenzhen Nanshan Center for Chronic Disease Control,Guangdong Province,Shenzhen 518054,China)

机构地区：[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

出　　处：《中国防痨杂志》2025年第5期577-581,共5页Chinese Journal of Antituberculosis

基　　金：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)。

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。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.

关 键 词：分枝杆菌 结核 核酸扩增技术 诊断 鉴别 对比研究 

分 类 号：R52[医药卫生—内科学]