Evaluation of the Xpert MTB/XDR test for detection of isoniazid, fluoroquinolones, and second-line injectable drugs resistance to Mycobacterium tuberculosis-Anhui Province, China

Introduction The emergence of drug-resistant tuberculosis (DR-TB) has posed significant challenges to TB control. This study assessed the diagnostic performance of the Xpert MTB/XDR test for detecting drug resistance in TB patients. Methods This study analyzed 276 samples collected from clinically suspected MDR-TB patients in Auhui Chest Hospital from 01/03/2022-01/03/2023. The Xpert MTB/XDR test was evaluated for its ability to detect resistance to isoniazid (INH), ethionamide (ETH), fluoroquinolones (FLQ), and second-line injectable drugs (SLIDs) compared with phenotypic drug susceptibility testing (pDST). Specimens were investigated by Sanger sequencing, where the MTB/XDR test and pDST results were inconsistent. Afterward, the clinical performance of the Xpert MTB/XDR test was also evaluated with the composite reference test (pDST + sequencing). Results The sensitivity of the Xpert MTB/XDR test against pDST in detecting resistance to INH and FLQ using 276 samples was 95.77% (95% CI: 91.83-98.16) and 93.83% (95% CI: 86.18-97.97), respectively. In contrast, a lower sensitivity of the MTB XDR test in predicting SLIDs and ETH resistance (sensitivity Conclusion The Xpert MTB/XDR has high sensitivity and specificity in drug-resistant tuberculosis patients, making it better suited to meet the needs of rapid, sensitive, and accurate detection for drug-resistant tuberculosis in resource-limited settings, and serving as a critical tool for achieving personalized treatment and TB control.