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中国防痨杂志 ›› 2025, Vol. 47 ›› Issue (6): 687-693.doi: 10.19982/j.issn.1000-6621.20250031

• 论著 • 上一篇    下一篇

新型PCR荧光探针技术用于结核病患者早期诊断的多中心应用评价研究

欧喜超1, 滕冲2, 宋媛媛1, 郑扬1, 陈磊3, 朱俊4, 王建国5, 潘兆宝3, 康海涛4, 王彦5, 么鸿雁6, 黄飞1()   

  1. 1传染病溯源预警与智能决策全国重点实验室,中国疾病预防控制中心结核病预防控制中心,北京 102206
    2北京市东城区疾病预防控制中心结核科,公共卫生应急管理创新中心,北京 100050
    3山东省潍坊市第二人民医院检验科,潍坊 261041
    4河南省周口市传染病医院(周口市结核病防治所)检验科,周口 466001
    5河北大学附属医院检验科,保定 071000
    6中国疾病预防控制中心教育培训处,北京 102206
  • 收稿日期:2025-01-20 出版日期:2025-06-10 发布日期:2025-06-11
  • 通信作者: 黄飞,Email:huangfei@chinacdc.cn
  • 作者简介:注:滕冲与欧喜超对本研究有同等贡献,为并列第一作者
  • 基金资助:
    国家重点研发计划(2022YFC2305204);国家重点研发计划(2023YFC2307301);西藏自治区重点研发计划(XZ202201ZY0007N-01);2528结核病预防控制项目

Multicenter evaluation study on the application of a novel PCR fluorescence probe technology for early diagnosis of tuberculosis

Ou Xichao1, Teng Chong2, Song Yuanyuan1, Zheng Yang1, Chen Lei3, Zhu Jun4, Wang Jianguo5, Pan Zhaobao3, Kang Haitao4, Wang Yan5, Yao Hongyan6, Huang Fei1()   

  1. 1National Key Laboratory of Intelligent Tracking and Forecasting for Infectious Diseases, National Center for Tuberculosis Control and Prevention, Chinese Center for Disease Control and Prevention, Beijing 102206, China
    2Department of Tuberculosis, Beijing Dongcheng District Center for Disease Control and Prevention, Public Health Emergency Management Innovation Center, Beijing 100050, China
    3Department of Laboratory Medicine, The Second People’s Hospital of Weifang, Shandong Province, Weifang 261041, China
    4Clinical Laboratory, Zhoukou Communicable Disease Hospital (Zhoukou Tuberculosis Dispensary), Henan Province, Zhoukou 466001, China
    5Clinical Laboratory, Affiliated Hospital of Hebei University, Baoding 071000, China
    6Department of Education and Training, Chinese Center for Disease Control and Prevention, Beijing 102206, China
  • Received:2025-01-20 Online:2025-06-10 Published:2025-06-11
  • Contact: Huang Fei, Email: huangfei@chinacdc.cn
  • Supported by:
    National Key Research and Development Program(2022YFC2305204);National Key Research and Development Program(2023YFC2307301);Key Research and Development Plan of Xizang Autonomous Region(XZ202201ZY0007N-01);2528 Tuberculosis Prevention and Control Project

摘要:

目的: 评价新型PCR-荧光探针(DiagMed qPCR,简称“qPCR”)技术在初诊疑似肺结核患者中进行结核病诊断的可靠性,为其在结核病早期诊断领域的推广应用提供基础数据支持。方法: 选择潍坊市第二人民医院、周口市传染病医院和河北大学附属医院作为项目现场实施单位,采用前瞻性研究,连续纳入2024年6—10月期间到医院就诊且符合纳入标准的初诊疑似肺结核患者。实验室工作人员对纳入患者送检痰或支气管肺泡灌洗液样本进行涂片染色镜检、MGIT 960液体培养、GeneXpert MTB/RIF(简称“Xpert”)和qPCR检测。结果: 最终纳入563例初诊疑似肺结核患者,涂片镜检阳性率为38.01%(214/563),液体培养阳性率为50.80%(286/563),Xpert检测阳性率为54.53%(307/563),qPCR检测阳性率为58.79%(331/563),qPCR检测阳性率和Xpert检测阳性率均明显高于液体培养,差异均有统计学意义(χ2=22.000,P<0.001;χ2=9.468,P=0.003)。以液体培养结果为参照标准,qPCR检测结核分枝杆菌的敏感度和特异度分别为92.31%(264/286)和75.74%(206/272),Xpert检测结核分枝杆菌的敏感度和特异度分别为91.07%(255/280)和80.60%(216/268)。以临床诊断结果为参照标准,qPCR检测敏感度和特异度分别为68.05%(328/482)和96.30%(78/81),Xpert检测敏感度和特异度分别为65.04%(307/472)和100.00%(78/78)。结论: qPCR检测结核分枝杆菌具有非常好的检测效能,可用于在重点人群进行结核病患者主动发现,在综合医疗机构和结核病定点医疗机构进行结核病患者早期诊断。

关键词: 分枝杆菌,结核, 聚合酶链反应, 诊断,鉴别, 评价研究

Abstract:

Objective: To evaluate the reliability of the novel PCR fluorescence probe technique (DiagMed qPCR, abbreviated as “qPCR”) in diagnosing tuberculosis among tuberculosis suspected patients and provide foundational data support for its clinical application in early tuberculosis diagnosis. Methods: Prospective studies were conducted at The Second People’s Hospital of Weifang, Zhoukou Communicable Disease Hospital, and Affiliated Hospital of Hebei University. Patients meeting inclusion criteria who presented with suspected initial TB diagnosis between June and October 2024 were consecutively enrolled. Laboratory staff performed smear staining microscopy, MGIT 960 liquid culture, GeneXpert MTB/RIF (abbreviated as “Xpert”), and qPCR on sputum or bronchoalveolar lavage fluid (BALF) samples from enrolled patients. Results: A total of 563 patients with suspected initial TB diagnosis were included. The smear microscopy positivity rate was 38.01% (214/563), liquid culture positivity rate was 50.80% (286/563), Xpert positivity rate was 54.53% (307/563), and qPCR positivity rate was 58.79% (331/563). Both qPCR and Xpert positivity rates were significantly higher than that of liquid culture (χ2=22.000, P<0.001; χ2=9.468, P=0.003). Using liquid culture as the reference standard, qPCR demonstrated a sensitivity of 92.31% (264/286) and specificity of 75.74% (206/272), while Xpert showed a sensitivity of 91.07% (255/280) and specificity of 80.60% (216/268). Using clinical diagnosis as the reference standard, qPCR exhibited a sensitivity of 68.05% (328/482) and specificity of 96.30% (78/81), whereas Xpert demonstrated a sensitivity of 65.04% (307/472) and specificity of 100.00% (78/78). Conclusion: The qPCR technique demonstrates excellent diagnostic performance for Mycobacterium tuberculosis detection. It can be utilized for active case finding in key populations and for early TB diagnosis in general healthcare institutions and designated TB medical facilities.

Key words: Mycobacterium tuberculosis, Polymerase chain reaction, Diagnosis, differential, Evaluation studies

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