title: GenoType® MTBDRplus assay detection of drug-resistant tuberculosis in routine practice in Korea.
abstract: METHODS
  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.
  
  
  METHODS
  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.
  
  
  CONCLUSIONS
  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.
authors.affiliation: Department of Pulmonary and Critical Care Medicine, Inje University Haeundae Paik Hospital, Haeundae-gu, Busan, South Korea.
authors.forename: J
authors.initials: J
authors.lastname: Lyu
authors.forename: M-N
authors.initials: MN
authors.lastname: Kim
authors.forename: J W
authors.initials: JW
authors.lastname: Song
authors.forename: C-M
authors.initials: CM
authors.lastname: Choi
authors.forename: Y-M
authors.initials: YM
authors.lastname: Oh
authors.forename: S D
authors.initials: SD
authors.lastname: Lee
authors.forename: W S
authors.initials: WS
authors.lastname: Kim
authors.forename: D S
authors.initials: DS
authors.lastname: Kim
authors.forename: T S
authors.initials: TS
authors.lastname: Shim
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D001431:Bacteriological Techniques / Q000379:methods; D005260:Female; D006801:Humans; D008297:Male; D008826:Microbial Sensitivity Tests; D008875:Middle Aged; D009169:Mycobacterium tuberculosis / Q000187:drug effects* / Q000235:genetics; D056910:Republic of Korea; D012189:Retrospective Studies; D012680:Sensitivity and Specificity; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis* / Q000382:microbiology*; D055815:Young Adult