GenoType® MTBDRplus assay detection of drug-resistant tuberculosis in routine practice in Korea.

SETTING

Korea is an intermediate-burden country with high rates of tuberculosis (TB) drug resistance.

OBJECTIVE

To evaluate the performance of the GenoType® MTBDRplus (MTBDR) assay in diagnosing drug-resistant TB in routine practice in Korea.

DESIGN

The MTBDR assay was performed on 428 samples, and the results were retrospectively compared with the results of conventional drug susceptibility testing (DST). The interval between treatment and diagnosis of drug resistance was also compared.

RESULTS

The sensitivity, specificity and positive and negative predictive values of the MTBDR assay were respectively 96.6%, 98.9%, 93.4% and 99.5% for the detection of rifampicin (RMP) resistance; 93.8%, 98.3%, 92.7% and 98.6% for isoniazid (INH) resistance; and 91.1%, 99.2%, 99.4% and 98.7% for multidrug-resistant TB (MDR-TB). The median interval between the start of anti-tuberculosis chemotherapy and the reporting of results was 88.9 days for conventional DST and 19.8 days for MTBDR using clinical specimens.

CONCLUSION

The specificity of the MTBDR assay in detecting MDR-TB was very high, although the sensitivity in detecting INH resistance and MDR-TB was not optimal (<95%). Although the turnaround time in detecting drug resistance was dramatically reduced with MTBDR compared to conventional DST, more effort is needed to shorten the turnaround time.