Wang Yilin, Cui Junwei, Li Yuanyuan, Wang Miao, Han Wenge, Liu Aimei, Wang Furong, Liu Rongmei, Kang Shuhui, Zhang Jianping, Zhu Sihong, Lai Zhonghai, Guan Wenlong, Zou Shaomu, Yin Xiangyu, Qing JianZhi, Mu Guilan, Guan Liying, Li Liang, Pang Yu
Department of Bacteriology and Immunology, Beijing Chest Hospital, Capital Medical University/Beijing Tuberculosis and Thoracic Tumor Research Institute, Beijing, China.
These authors contributed equally to this work.
Eur Respir J. 2025 Jan 2;65(1). doi: 10.1183/13993003.01493-2024. Print 2025 Jan.
Tuberculosis (TB) remains a major cause of infectious disease mortality globally, with significant underdiagnosis perpetuating transmission. Tongue swab analysis has emerged as a promising non-invasive method for pulmonary TB diagnosis. This study evaluates the diagnostic accuracy of the TB-EASY quantitative PCR (qPCR) assay using tongue swab specimens.
In this prospective multicentre study, conducted across seven designated TB hospitals in China, 729 participants were included in the analysis. Tongue swabs were tested using the new TB-EASY assay from Hugobiotech, while sputum samples were analysed by Xpert MTB/RIF (Xpert), smear and culture tests. Diagnostic performance was compared to a composite microbiological reference standard (MRS).
The TB-EASY assay demonstrated high diagnostic accuracy, with sensitivity and specificity of 89.6% and 96.2% compared to sputum Xpert, and 87.4% and 98.0% compared to the MRS. Sensitivity varied by bacterial load, ranging from 100% in high-load cases to 70.4% in very-low-load cases. The assay demonstrated robust performance in diverse epidemiological settings.
The TB-EASY qPCR assay using tongue swabs offers a reliable, non-invasive diagnostic alternative for pulmonary TB, especially where sputum collection is challenging. Its potential for wider use in high TB burden settings warrants further validation in community-based studies. Limitations include potential overestimation of sensitivity due to the selection of symptomatic patients and the use of sputum Xpert rather than Xpert Ultra. Additionally, the performance in non-sputum-producing patients remains untested, and the cost-effectiveness should be further evaluated to assess the feasibility of its implementation.
结核病仍然是全球传染病死亡的主要原因，诊断不足严重导致疾病传播。舌拭子分析已成为一种有前景的肺结核诊断非侵入性方法。本研究评估了使用舌拭子标本的TB-EASY定量聚合酶链反应（qPCR）检测的诊断准确性。
在这项前瞻性多中心研究中，在中国七家指定的结核病医院进行，729名参与者纳入分析。使用Hugobiotech公司的新型TB-EASY检测对舌拭子进行检测，同时对痰标本进行Xpert MTB/RIF（Xpert）、涂片和培养检测。将诊断性能与综合微生物学参考标准（MRS）进行比较。
TB-EASY检测显示出较高的诊断准确性，与痰Xpert检测相比，灵敏度和特异性分别为89.6%和96.2%，与MRS相比分别为87.4%和98.0%。灵敏度因细菌载量而异，高载量病例中为100%，极低载量病例中为70.4%。该检测在不同的流行病学环境中表现出稳健的性能。
使用舌拭子的TB-EASY qPCR检测为肺结核提供了一种可靠的非侵入性诊断方法，特别是在痰标本采集具有挑战性的情况下。其在高结核病负担地区更广泛应用的潜力值得在基于社区的研究中进一步验证。局限性包括由于选择有症状的患者以及使用痰Xpert而非Xpert Ultra可能高估灵敏度。此外，在无痰患者中的性能尚未测试，应进一步评估成本效益以评估其实施的可行性。
