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中国防痨杂志 ›› 2026, Vol. 48 ›› Issue (2): 289-298.doi: 10.19982/j.issn.1000-6621.20250300

• 论著 • 上一篇    下一篇

AIMTB-荧光免疫层析法对结核分枝杆菌潜伏感染筛查的诊断价值

周藏1, 李国莉1, 蒋晖2, 邵燕1, 宋红焕1, 薛浩3, 宁静娴1,4, 潘昱辰1,5, 费心如1,2, 孙郑1,4, 陈诚1, 竺丽梅1, 刘巧1()   

  1. 1 江苏省疾病预防控制中心慢性传染病防制所, 南京 210009
    2 镇江市疾病预防控制中心慢性传染病防制所, 镇江 212000
    3 盐城市疾病预防控制中心慢性传染病防制所, 盐城 224000
    4 南京医科大学公共卫生学院流行病学系, 南京 211166
    5 东南大学公共卫生学院流行病学系, 南京 210096
  • 收稿日期:2025-07-22 出版日期:2026-02-10 发布日期:2026-02-03
  • 通信作者: 刘巧 E-mail:liuqiaonjmu@163.com
  • 基金资助:
    国家自然科学基金(82574173);国家自然科学基金(82003516);江苏省卫生健康委员会科研面上项目(M2020020)

Evaluation of the diagnostic efficacy of AIMTB-fluorescent immunochromatography for screening latent tuberculosis infection

Zhou Cang1, Li Guoli1, Jiang Hui2, Shao Yan1, Song Honghuan1, Xue Hao3, Ning Jingxian1,4, Pan Yuchen1,5, Fei Xinru1,2, Sun Zheng1,4, Chen Cheng1, Zhu Limei1, Liu Qiao1()   

  1. 1 Institute of Chronic Infectious Disease, Jiangsu Provincial Center for Disease Control and Prevention, Nanjing 210009, China
    2 Institute of Chronic Infectious Disease, Zhenjiang Center for Disease Control and Prevention, Zhenjiang 212000, China
    3 Institute of Chronic Infectious Disease, Yancheng Center for Disease Control and Prevention, Yancheng 224000, China
    4 Department of Epidemiology, School of Public Health, Nanjing Medical University, Nanjing 211166, China
    5 Department of Epidemiology, School of Public Health, Southeast University, Nanjing 210096, China
  • Received:2025-07-22 Online:2026-02-10 Published:2026-02-03
  • Contact: Liu Qiao E-mail:liuqiaonjmu@163.com
  • Supported by:
    National Natural Science Foundation of China(82574173);National Natural Science Foundation of China(82003516);General Research Project of Jiangsu Provincial Health Commission(M2020020)

摘要:

目的: 评价AIMTB-荧光免疫层析法(AIMTB-fluorescent immunoassay,AIMTB-FIA)在不同人群结核分枝杆菌潜伏感染(latent tuberculosis infection, LTBI)筛查中的诊断性能。方法: 采用横断面研究方法,参照入组标准于2025年3—4月选取江苏省镇江市某福利院人员和盐城市某社区医务工作者作为研究对象。以QuantiFERON-TB Gold Plus(QFT-Plus)检测结果为参照标准,通过计算Kappa值、一致率及受试者工作特征(receiver operating characteristic,ROC)曲线下面积(area under curve,AUC)评估AIMTB-FIA与QFT-Plus检测结果的一致性及其诊断效能。进一步通过亚组分析比较不同人群来源(福利院人员与社区医务工作者)和不同年龄组间(65岁及以上与65岁以下)的检测性能差异。结果: 共纳入396名研究对象,其中福利院人员239名,社区医务工作者157名。QFT-Plus检测LTBI率为11.62%(46/396),AIMTB-FIA检测LTBI率为17.93%(71/396)。以QFT-plus检测结果为参照标准,AIMTB-FIA检测的敏感度、特异度、一致率、Kappa值和AUC(95%CI)值分别为97.80%(45/46)、92.60%(324/350)、93.20%、0.731和0.988。亚组分析显示,AIMTB-FIA检测不同人群和不同年龄组的Kappa值介于0.628~0.879,AUC范围为0.977~0.992,均显示出良好的诊断效能。Spearman相关性检验显示,AIMTB-FIA检测的T-N中IFN-γ水平与QFT-Plus检测中TB1-Nil和TB2-Nil的IFN-γ水平均呈中等正相关(r值分别为0.638、0.631,P值均<0.001)。结论: AIMTB-FIA作为一种优化的γ-干扰素释放试验检测试剂,与QFT-Plus具有高度一致性,且操作简便、检测时间短,可作为基层医疗机构LTBI筛查的可靠替代方法。

关键词: 分枝杆菌感染, 荧光免疫测定, 干扰素γ, 诊断技术和方法, 评价研究

Abstract:

Objective: To evaluate the diagnostic performance of the AIMTB-fluorescent immunoassay ( AIMTB-FIA) for screening latent tuberculosis infection (LTBI) in different populations. Methods: A cross-sectional study was conducted. Participants were enrolled according to inclusion criteria from a welfare institution in Zhenjiang City and community healthcare workers in Yancheng City, Jiangsu Province, in March-Apirl, 2025. QuantiFERON-TB Gold Plus (QFT-Plus) assay was used as the reference standard. Consistency and diagnostic efficacy of AIMTB-FIA relative to QFT-Plus were assessed by calculating the Kappa coefficient, overall agreement rate, and the area under the receiver operating characteristic curve (AUC). Subgroup analyses were further performed to compare the diagnostic performance of AIMTB-FIA across different population sources (welfare institution residents vs. community healthcare workers) and age groups (≥65 years vs. <65 years). Results: A total of 396 participants were enrolled, including 239 from welfare institution and 157 community healthcare workers. The positivity rate of QFT-Plus was 11.62% (46/396), while that of AIMTB-FIA was 17.93% (71/396). Using QFT-Plus as the reference standard, the AIMTB-FIA demonstrated a sensitivity of 97.80% (45/46), specificity of 92.60% (324/350), overall agreement rate of 93.20%, Kappa value of 0.731, and an AUC of 0.988. Subgroup analyses revealed that the Kappa values ranged from 0.628 to 0.879, and AUCs ranged from 0.977 to 0.992 across different populations and age groups, indicating consistently robust diagnostic performance. Spearman’s correlation analysis showed a moderate positive correlations between the T-N values of the AIMTB-FIA and the interferon-gamma (IFN-γ) levels of TB1-Nil and TB2-Nil of the QFT-Plus assay (r=0.631, 0.638; Ps<0.001). Conclusion: As an optimized interferon-gamma release assay, AIMTB-FIA exhibits high concordance with QFT-Plus, with advantages of simplified operation and reduced detection time. It has potential as a reliable alternative for LTBI screening in primary healthcare settings.

Key words: Mycobacterium infections, Fluoroimmunoassay, Interferon-gamma, Diagnostic techniques and procedures, Evaluation studies

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