A cartridge-based assay for improved detection of multidrug-resistant Mycobacterium tuberculosis directly from sputum - PubMed
6 hours ago
- #Tuberculosis
- #Molecular Diagnostics
- #Drug Resistance
- A new cartridge-based assay called MDRmDx was developed for improved detection of multidrug-resistant Mycobacterium tuberculosis directly from sputum, detecting TB, rifampicin resistance (including I491F mutations), and isoniazid resistance.
- MDRmDx performed comparably to the Xpert MTB/RIF Ultra assay in analytical studies, with similar limits of detection for TB and rifampicin susceptibility, while also detecting isoniazid resistance with high sensitivity and specificity.
- In clinical testing on enriched sputum samples, MDRmDx showed high sensitivity (91.3% for TB detection, 100% for rifampicin resistance, 98.7% for isoniazid resistance) and specificity (up to 100% for some measures), with performance at least equal to Ultra.
- The assay addresses a gap in current tests by detecting isoniazid resistance and previously missed rifampicin resistance mutations, potentially improving treatment selection for drug-resistant TB.