He Yijun, Shen Lingyu, Du Jiang, Cao Xuefang, Zhang Bin, Wang Dakuan, Feng Boxuan, Li Zihan, Di Yuanzhi, Huang Juanjuan, Guo Tonglei, Liang Jianguo, Yan Jiaoxia, Liu Zisen, Jin Qi, Duan Weitao, Xin Henan, Gao Lei
NHC Key Laboratory of Systems Biology of Pathogens, National Institute of Pathogen Biology, and Center for Tuberculosis Research, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China; Key Laboratory of Pathogen Infection Prevention and Control (Ministry of Education), National Institute of Pathogen Biology, Chinese Academy of Medical Sciences and Peking Union Medical College, Beijing, People's Republic of China.
Center for Diseases Control and Prevention of Zhongmu, Zhengzhou, People's Republic of China.
Clin Microbiol Infect. 2025 Feb;31(2):290.e1-290.e3. doi: 10.1016/j.cmi.2024.10.016. Epub 2024 Oct 23.
To determine the agreement of Mycobacterium tuberculosis (MTB) antigen-based skin test (TBST) with interferon-gamma release assay (IGRA) in the elderly individuals aged ≥65 years beyond instruction for use in China.
Based on the baseline survey of a randomized controlled trial with the objective of exploring suitable regimens for tuberculosis(TB) preventive treatment, MTB infection was tested using TBST and IGRA in parallel in rural residents aged 50-70 years using a cross-sectional study design.
A total of 21 219 participants with both TBST and IGRA results were included in this analysis. The concordance between TBST and IGRA was 89.4% (95% CI, 89.0-89.8%) with a kappa coefficient of 0.61 (95% CI, 0.60-0.62). In those aged ≥65 years, the concordance was 86.5% (95% CI, 85.6-87.4%) with a kappa coefficient of 0.55 (95% CI, 0.52-0.58). 21.2% (35/165) of the participants with indeterminate IGRA results were TBST positive, and nine of them were aged ≥65 years.
The consistent agreement between TBST and IGRA in individuals aged ≥65 years suggests that TBST has the potential to be used in the elderly with age beyond instruction for use in China. The respective diagnostic performance of each test will be analysed when the longitudinal data on incident TB is obtained in the future.
在中国超出使用说明的情况下,确定基于结核分枝杆菌(MTB)抗原的皮肤试验(TBST)与干扰素-γ释放试验(IGRA)在65岁及以上老年人中的一致性。
基于一项随机对照试验的基线调查,目的是探索结核病(TB)预防性治疗的合适方案,采用横断面研究设计,对50-70岁农村居民同时使用TBST和IGRA检测MTB感染情况。
本分析纳入了21219名同时有TBST和IGRA结果的参与者。TBST与IGRA的一致性为89.4%(95%CI,89.0-89.8%),kappa系数为0.61(95%CI,0.60-0.62)。在65岁及以上人群中,一致性为86.5%(95%CI,85.6-87.4%),kappa系数为0.55(95%CI,0.52-0.58)。IGRA结果不确定的参与者中有21.2%(35/165)TBST呈阳性,其中9人年龄在65岁及以上。
65岁及以上人群中TBST与IGRA的一致相符表明,TBST有可能用于超出中国使用说明年龄范围的老年人。未来获得结核病发病的纵向数据时,将分析每种检测方法各自的诊断性能。