Abstract

This study evaluated the diagnostic performance of the AccuPower® TB&MDR Real-Time PCR (TBMDR®) and AccuPower® XDR-TB Real-Time PCR Kit-A (XDRA®) to detect multidrug-resistant (MDR-TB) and extensively drug-resistant tuberculosis (XDR-TB) in comparison with phenotypic drug susceptibility testing (DST) using MGIT 960 on 234 clinical Mycobacterium tuberculosis isolates. Discrepant results were confirmed by direct-sequencing. Sensitivity and specificity of TBMDR and XDRA for cultured isolates were 81.2% (95% CI, 74.81-86.53%) and 95.8% (95% CI, 86.75-99.49%) for isoniazid resistance, 95.7% (95% CI, 91.79-98.15%) and 95.7% (95% CI, 85.16-99.47%) for rifampicin resistance, 84.1% (95% CI, 76.56-90.03%) and 99.1% (95% CI, 94.95-99.98%) for fluoroquinolone resistance, and 67.4% (95% CI, 56.82-76.80%) and 100% (95% CI, 97.44-100.00%) for second-line injectables resistance. The sensitivities of each drug were equivalent to other molecular DST methods. High concordance was observed when compared to direct-sequencing. Our study showed TBMDR and XDRA assays could be the useful tools to detect MDR-TB and XDR-TB.

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