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中国防痨杂志 ›› 2024, Vol. 46 ›› Issue (8): 897-902.doi: 10.19982/j.issn.1000-6621.20240137

• 论著 • 上一篇    下一篇

重组结核杆菌融合蛋白在肺结核密切接触者中筛查结核分枝杆菌感染效果分析

徐春华1, 朱士玉2, 胡屹3, 易可华4, 宋灿磊5, 王紫纯1, 邬勇6, 王青1, 杨芊茹7, 沈鑫8()   

  1. 1上海市奉贤区疾病预防控制中心性结防科,上海 201499
    2上海市金山区疾病预防控制中心性结科,上海 201599
    3复旦大学公共卫生学院流行病学教研室,上海 200032
    4上海市奉贤区疾病预防控制中心,上海 201499
    5上海市金山区疾病预防控制中心,上海 201599
    6上海市奉贤区海湾镇社区卫生服务中心预防保健科,上海 201419
    7复旦大学生命科学学院,上海 200032
    8上海市疾病预防控制中心,上海 200336
  • 收稿日期:2024-04-11 出版日期:2024-08-10 发布日期:2024-08-01
  • 通信作者: 沈鑫 E-mail:shenxin@scdc.sh.cn
  • 基金资助:
    上海市加强公共卫生体系建设三年行动计划(2023—2025 年)项目(GWVI-9);上海市加强公共卫生体系建设三年行动计划(2023—2025 年)重点学科(GWVI-11.1-05);2023年东方英才计划拔尖项目(2023-2025);上海市疾病预防控制青年骨干人才培养项目(22QNGG18)

Analysis of screening effect of recombinant Mycobacterium tuberculosis fusion protein in screening Mycobacterium tuberculosis infection in close contacts of pulmonary tuberculosis patients

Xu Chunhua1, Zhu Shiyu2, Hu Yi3, Yi Kehua4, Song Canlei5, Wang Zichun1, Wu Yong6, Wang Qing1, Yang Qianru7, Shen Xin8()   

  1. 1Department of Sexually Transmitted Diseases and Tuberculosis Prevention and Control, Fengxian District Center for Disease Control and Prevention, Shanghai 201499,China
    2Department of Sexually Transmitted Diseases and Tuberculosis Prevention and Control,Jinshan District Center for Disease Control and Prevention, Shanghai 201599,China
    3Department of Epidemiology, School of Public Health, Fudan University, Shanghai 200032,China
    4Fengxian District Center for Disease Control and Prevention, Shanghai 201499, China
    5Jinshan District Center for Disease Control and Prevention, Shanghai 201599, China
    6Department of Preventive Healthcare, Haiwan Community Health Service Center in Fengxian District, Shanghai 201419,China
    7School of Life Sciences, Fudan University, Shanghai 200032,China
    8Shanghai Municipal Center for Disease Control and Prevention, Shanghai 200336,China
  • Received:2024-04-11 Online:2024-08-10 Published:2024-08-01
  • Contact: Shen Xin E-mail:shenxin@scdc.sh.cn
  • Supported by:
    Three-Year Initiative Plan (2023—2025) for Strengthening Public Health System Construction in Shanghai(GWVI-9);Key Disciplines of Three-Year Initiative Plan (2023—2025) for Strengthening Public Health System Construction in Shanghai(GWVI-11.1-05);Shanghai Oriental Talents Plan Top-notch Project(2023-2025);The Youth Backbone Talent Training Project of Shanghai Center for Disease Control and Prevention(22QNGG18)

摘要:

目的: 探讨重组结核杆菌融合蛋白 (recombinant mycobacterium tuberculosis fusion protein,EC)皮肤试验在筛查肺结核患者密切接触者结核分枝杆菌感染中的实用性和有效性,为进一步优化结核感染检测提供技术建议,了解密切接触者结核分枝杆菌潜伏感染(LTBI)现状。方法: 2023年10月23日至11月14日在上海市奉贤区和金山区共选取140名肺结核密切接触者作为研究对象,对每名研究对象同时采用γ-干扰素释放试验(IGRA)和EC皮肤试验进行结核感染检测,采用 Kappa值检验两种方法结果一致性,采用χ2 检验比较两组检测方法之间的差异,以P<0.05 为差异有统计学意义。结果: 140名研究对象,包括男性55例,女性85例;IGRA阳性率为15.00%(21/140),EC皮肤试验阳性率为14.29%(20/140),两种试验方法一致性检验Kappa值为 0.857,差异无统计学意义(χ2=0.029,P=0.866),两种检测方法检测结果为高度一致性;以IGRA作为结核感染的参考标准,EC 皮肤试验的敏感度为 85.71%(18/21)、特异度为 98.32%(117/119)、阳性预测值为 90.00%(18/20)、阴性预测值为 97.50%(117/120);男性EC阳性率(32.73%,18/55)明显高于女性(2.35%,2/85),差异有统计学意义(χ2=17.983,P<0.001)。结论: EC皮肤试验具有较强的特异性,可用于肺结核密切接触者结核分枝杆菌感染筛查,但受限于使用年龄和接种禁忌证,可采用IGRA对无法进行EC皮肤试验者进行补充检测。

关键词: 分枝杆菌,结核, 接触者追踪, 分枝杆菌感染, 重组结核杆菌融合蛋白

Abstract:

Objective: To evaluate the accuracy and feasibility of recombinant Mycobacterium tuberculosis fusion protein (EC) skin test in tuberculosis screening among close contacts of pulmonary tuberculosis patients and to provide technical recommendations for improving tuberculosis control,and to understand the status of latent infection of Mycobacterium tuberculosis (LTBI) in close contacts. Methods: A total of 140 close contacts of tuberculosis patients from Fengxian and Jinshan Districts in Shanghai City were selected as the study subjects. Both IGRA and EC skin tests were administered. Kappa test was used to assess the consistency between the results of those two methods, and chi-square test was employed to compare the differences between these two detection methods. A P-value of <0.05 was considered statistically significant. Results: A total of 140 subjects were included in the study, consisting of 55 males and 85 females. The positive rate of IGRA was 15.00% (21/140), while the positive rate of EC skin test was 14.29% (20/140). There was no statistically significant difference between them (χ2=0.029, P=0.866), with a Kappa value of 0.857 (P=0.001), indicating a high degree of consistency. When IGRA was used as the reference standard for tuberculosis infection, EC skin test demonstrated a sensitivity of 85.71% (18/21), a specificity of 98.32% (117/119), a positive predictive value of 90.00% (18/20), and a negative predictive value of 97.50% (117/120). The positive rate of EC in males (32.73%, 18/55) was significantly higher than that in females (2.35%, 2/85), and the difference was statistically significant (χ2=17.983,P<0.001). Conclusion: EC skin test demonstrates high specificity and can be utilized for Mycobacterium tuberculosis infection screening among close contacts of tuberculosis patients. However, due to limitations regarding age range and contraindications for use, implementing a combined screening method of EC and IGRA is advisable.

Key words: Mycobacterium tuberculosis, Contact tracing, Mycobacterium infections, Recombinant Mycobacterium tuberculosis fusion protein

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