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  

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

作　　者：徐春华[1] 朱士玉[2] 胡屹 易可华 宋灿磊[5] 王紫纯 邬勇 王青 杨芊茹 沈鑫[8] Xu Chunhua;Zhu Shiyu;Hu Yi;Yi Kehua;Song Canlei;Wang Zichun;Wu Yong;Wang Qing;Yang Qianru;Shen Xin(Department of Sexually Transmitted Diseases and Tuberculosis Prevention and Control,Fengxian District Center for Disease Control and Prevention,Shanghai 201499,China;Department of Sexually Transmitted Diseases and Tuberculosis Prevention and Control,Jinshan District Center for Disease Control and Prevention,Shanghai 201599,China;Department of Epidemiology,School of Public Health,Fudan University,Shanghai 200032,China;Fengxian District Center for Disease Control and Prevention,Shanghai 201499,China;Jinshan District Center for Disease Control and Prevention,Shanghai 201599,China;Department of Preventive Healthcare,Haiwan Community Health Service Center in Fengxian District,Shanghai 201419,China;School of Life Sciences,Fudan University,Shanghai 200032,China;Shanghai Municipal Center for Disease Control and Prevention,Shanghai 200336,China)

机构地区：[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

出　　处：《中国防痨杂志》2024年第8期897-902,共6页Chinese Journal of Antituberculosis

基　　金：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)。

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χ^(2)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(χ^(2)=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(χ^(2)=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。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(χ^(2)=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(χ^(2)=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.

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 

分 类 号：R521[医药卫生—内科学] R184.6[医药卫生—临床医学]