Abstract
Tuberculosis (TB) remains a major global health threat, with the urgent need for rapid and accurate diagnostic methods to improve control and treatment outcomes. This study evaluates the performance of MassARRAY technology for detecting Mycobacterium tuberculosis (MTB) and identifying drug resistance, compared to traditional culture methods and Xpert MTB/RIF. From July 2021 to February 2024, bronchoalveolar lavage fluid (BALF) samples from 289 suspected pulmonary tuberculosis patients at Henan Provincial Chest Hospital, China, were tested using MassARRAY, Xpert MTB/RIF, and conventional culturing techniques. The performance of each method was assessed for MTB detection, and the ability of MassARRAY to identify drug resistance was compared with standard drug susceptibility testing (DST). MassARRAY demonstrated a sensitivity of 96.5% and a specificity of 34.6% for MTB detection, outperforming the Xpert MTB/RIF assay in sensitivity (94.7%) but showing lower specificity. In detecting rifampicin resistance, MassARRAY achieved concordance rates of 83.93% with Xpert MTB/RIF and 72.73% with DST. Furthermore, MassARRAY successfully identified key genetic mutations associated with drug resistance, such as rpoB 531 for rifampicin and katG 315 for isoniazid. MassARRAY demonstrated high concordance with DST for several drugs, including isoniazid, kanamycin, and streptomycin, but exhibited limitations in detecting resistance to pyrazinamide, clofazimine, cycloserine, and linezolid. Overall, MassARRAY provides a rapid, cost-effective, and high-throughput diagnostic platform for MTB and drug resistance, particularly for first-line anti-tuberculosis drugs. While limitations in specificity and resistance detection for certain second-line drugs exist, its ability to rapidly provide comprehensive resistance profiles makes it a valuable tool for TB management.