Yan Hongxia, Duan Hongfei, Han Xiaoxu, Sun Jin, Liang Qingtao, Zhao Yan, Ma Zhenglai, Ding Ning, Ren Meixin, Jiang Taiyi, Zhang Tong, Su Bin
Sino-French Joint Laboratory for HIV/AIDS Research, Clinical and Research Center for Infectious Diseases, Beijing Youan Hospital, Capital Medical University, Beijing 100069, China.
Department of Tuberculosis, Beijing Chest Hospital, Capital Medical University, Beijing, China.
China CDC Wkly. 2025 Aug 22;7(34):1106-1113. doi: 10.46234/ccdcw2025.186.
Diagnosing tuberculosis (TB) in HIV-infected individuals presents significant challenges due to difficulties in obtaining specimens containing adequate quantities of (). This study aimed to evaluate the diagnostic performance of the mRNA assay independently and in combination with established diagnostic tests for detection.
The study cohort comprised 111 HIV-infected individuals who presented with TB at Beijing Youan Hospital from 2022 to 2024. Participants were categorized into confirmed TB, probable TB, or non-TB groups according to the diagnostic criteria for tuberculosis (WS288-2017). The performance of the mRNA release assay was evaluated by the STARD guidelines on blood samples collected after enrollment.
The mRNA release assay demonstrated significantly higher sensitivity than interferon-γ release assays (IGRAs) and culture methods for confirming pulmonary tuberculosis (PTB) diagnosis while maintaining comparable specificity. Receiver operating characteristic (ROC) analysis revealed that the diagnostic performance of the mRNA release assay used in parallel with Xpert MTB/RIF significantly exceeded that of the mRNA release assay alone (0.731 . 0.687, =0.02). Among HIV-infected individuals, the mRNA release assay showed superior performance compared to IGRAs for diagnosing extrapulmonary tuberculosis.
The mRNA release assay exhibited excellent diagnostic performance and demonstrates substantial potential as an auxiliary tool for diagnosing TB in HIV-infected individuals. The combined application of IP-10TB and Xpert MTB/RIF further enhance diagnostic efficacy.
由于难以获取含有足够量()的标本,在艾滋病毒感染者中诊断结核病面临重大挑战。本研究旨在独立评估mRNA检测法的诊断性能,并将其与用于检测的既定诊断测试相结合进行评估。
研究队列包括2022年至2024年在北京佑安医院出现结核病症状的111名艾滋病毒感染者。根据结核病诊断标准(WS288-2017),将参与者分为确诊结核病、疑似结核病或非结核病组。在入组后采集的血样上,按照STARD指南评估mRNA释放检测法的性能。
在确诊肺结核(PTB)诊断方面,mRNA释放检测法显示出比干扰素-γ释放检测法(IGRAs)和培养方法显著更高的敏感性,同时保持了相当的特异性。受试者操作特征(ROC)分析显示,与Xpert MTB/RIF并行使用的mRNA释放检测法的诊断性能显著超过单独使用mRNA释放检测法(0.731对0.687,P=0.02)。在艾滋病毒感染者中,mRNA释放检测法在诊断肺外结核病方面比IGRAs表现更优。
mRNA释放检测法表现出优异的诊断性能,作为艾滋病毒感染者结核病诊断的辅助工具具有巨大潜力。IP-10TB和Xpert MTB/RIF的联合应用进一步提高了诊断效率。