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&#x2009;<&#x2009;75%) compared with pDST was demonstrated in this study. The specificity for detecting all drugs was greater than 90%. Thirty-three samples were retested by sequencing, which identified mutations predicting INH and FLQ resistance, determining whether resistant or not by combining pDST and sequencing results. When considering pDST&#x2009;+&#x2009;sequencing, the sensitivity and specificity of the MTB/XDR assay for INH and FLQ drug targets increased, especially the detection specificity of FLQ has reached 100% (95% CI: 97.95-100).

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.