Evaluation of the laboratory performance of MolecuTech®REBA MTB-MDR kit for the detection of multidrug resistant tuberculosis.

This study evaluated the performance of the MolecuTech® REBA MTB-MDR kit, a molecular diagnostic tool developed by YD Diagnostics, for MDR-TB detection. We assessed 174 clinical Mycobacterium tuberculosis isolates. The MolecuTech® REBA MTB-MDR kit performance was compared with the Hain MTBDRplus assay and sequencing analysis. Sensitivity, specificity, and concordance for detecting isoniazid (INH) and rifampicin (RIF) resistance were evaluated. The MolecuTech® REBA MTB-MDR kit demonstrated high sensitivity and specificity for both INH (100% and 100%, respectively) and RIF (100% and 100%, respectively) resistance detection. The inclusion of the ahpC gene target enhanced INH resistance detection. The automated HybREAD480® system improved workflow efficiency and reduced human error. The MolecuTech® REBA MTB-MDR kit shows promising performance for rapid MDR-TB detection, comparable or superior to the World Health Organization (WHO)-recommended Hain MTBDRplus assay. This study showed that the MolecuTech® REBA MTB-MDR kit is expected to contribute to developing effective tuberculosis treatment strategies in clinical settings.