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已发表论文
核苷酸基质辅助激光解吸电离飞行时间质谱（MALDI-TOF-MS）对肺结核快速诊断及耐药检测的诊断性能
Received 31 July 2025
Accepted for publication 2 October 2025
Published 13 October 2025 Volume 2025:18 Pages 5307—5314
DOI https://doi.org/10.2147/IDR.S557297
Checked for plagiarism Yes
Review by Single anonymous peer review
Peer reviewer comments 3
Editor who approved publication: Dr Hazrat Bilal
Yi Shen,1 Jianping Liu2
1Department of Respiratory and Critical Care Medicine, Affiliated Hospital of Hangzhou Normal University, Hangzhou, Zhejiang, People’s Republic of China; 2Department of Tuberculosis, Affiliated Hospital of Hangzhou Normal University, Hangzhou, Zhejiang, People’s Republic of China
Correspondence: Jianping Liu, Email liujianping199501@163.com
Objective: This study aims to evaluate the diagnostic performance of nucleotide MALDI-TOF-MS in the rapid diagnosis of pulmonary tuberculosis and the detection of drug resistance.
Methods: A retrospective study was conducted on suspected pulmonary tuberculosis patients (total of 110) admitted to Affiliated Hospital of Hangzhou Normal University between November 2020 to April 2024. The age of all patients range of the patients was 19 to 90 years, and the mean age was 55.1± 20.9 years. Of the enrolled participants, 59 (53.6%) were males and 51 (46.4%) were females. The study involved calculating and comparing the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of nucleotide MALDI-TOF-MS, MGIT960 culture, and Xpert MTB/RIF.
Results: According to the clinical diagnosis reference standard, the sensitivity, specificity, PPV, and NPV of nucleotide MALDI-TOF-MS for detecting Mycobacterium tuberculosis (MTB) were 84.2% (95% CI: 74.4– 94.0%), 92.5% (85.1– 99.8%), 92.3% (84.8– 99.8%), and 84.5% (74.9– 94.4%). The MGIT960 culture method served as the reference standard, and the nucleotide MALDI-TOF-MS demonstrated a sensitivity of 100.0% (95% CI: 88.3– 100%), specificity of 71.6% (61.6– 81.6%), PPV of 55.8% (41.8– 69.7%), and NPV of 100.0% (93.8– 100.0%) in identifying MTB. Regarding drug resistance, the nucleic acid MALDI-TOF-MS technique shows a high level of agreement with conventional culture methods in identifying resistance to isoniazid, rifampicin, streptomycin and ethambutol.
Conclusion: Nucleotide MALDI-TOF-MS demonstrates good diagnostic efficacy in the rapid diagnosis of pulmonary tuberculosis and the assessment of drug resistance, positioning it as a promising technique for the diagnosis of Mycobacterium tuberculosis.
Keywords: tuberculosis, nucleotide MALDI-TOF-MS, drug resistance
1Department of Respiratory and Critical Care Medicine, Affiliated Hospital of Hangzhou Normal University, Hangzhou, Zhejiang, People’s Republic of China; 2Department of Tuberculosis, Affiliated Hospital of Hangzhou Normal University, Hangzhou, Zhejiang, People’s Republic of China
Correspondence: Jianping Liu, Email liujianping199501@163.com
Objective: This study aims to evaluate the diagnostic performance of nucleotide MALDI-TOF-MS in the rapid diagnosis of pulmonary tuberculosis and the detection of drug resistance.
Methods: A retrospective study was conducted on suspected pulmonary tuberculosis patients (total of 110) admitted to Affiliated Hospital of Hangzhou Normal University between November 2020 to April 2024. The age of all patients range of the patients was 19 to 90 years, and the mean age was 55.1± 20.9 years. Of the enrolled participants, 59 (53.6%) were males and 51 (46.4%) were females. The study involved calculating and comparing the sensitivity, specificity, positive predictive value (PPV), and negative predictive value (NPV) of nucleotide MALDI-TOF-MS, MGIT960 culture, and Xpert MTB/RIF.
Results: According to the clinical diagnosis reference standard, the sensitivity, specificity, PPV, and NPV of nucleotide MALDI-TOF-MS for detecting Mycobacterium tuberculosis (MTB) were 84.2% (95% CI: 74.4– 94.0%), 92.5% (85.1– 99.8%), 92.3% (84.8– 99.8%), and 84.5% (74.9– 94.4%). The MGIT960 culture method served as the reference standard, and the nucleotide MALDI-TOF-MS demonstrated a sensitivity of 100.0% (95% CI: 88.3– 100%), specificity of 71.6% (61.6– 81.6%), PPV of 55.8% (41.8– 69.7%), and NPV of 100.0% (93.8– 100.0%) in identifying MTB. Regarding drug resistance, the nucleic acid MALDI-TOF-MS technique shows a high level of agreement with conventional culture methods in identifying resistance to isoniazid, rifampicin, streptomycin and ethambutol.
Conclusion: Nucleotide MALDI-TOF-MS demonstrates good diagnostic efficacy in the rapid diagnosis of pulmonary tuberculosis and the assessment of drug resistance, positioning it as a promising technique for the diagnosis of Mycobacterium tuberculosis.
Keywords: tuberculosis, nucleotide MALDI-TOF-MS, drug resistance