Diagnostic Performance of Nucleotide MALDI-TOF-MS for the Rapid Diagnosis of Pulmonary Tuberculosis and the Detection of Drug Resistance

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 ChinaCorrespondence: Jianping Liu, Email [email protected]: 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