title: First proficiency testing of second-line anti-tuberculosis drug susceptibility testing in 12 provinces of China.
abstract: OBJECTIVE
  To evaluate the performance of drug susceptibility testing (DST) against the main second-line (SL) anti-tuberculosis drugs in tuberculosis (TB) laboratories in China.
  
  
  METHODS
  The supranational TB reference laboratory issued 30 Mycobacterium tuberculosis isolates to the participating laboratories. Each participating laboratory performed DST against kanamycin (KM), amikacin (AMK), capreomycin (CPM) and ofloxacin (OFX) using the proportion method in Löwenstein-Jensen medium per World Health Organization recommendations. Reported results were checked and compared with the judicial results.
  
  
  RESULTS
  The main performance indicators for the four anti-tuberculosis drugs evaluated (KM, AMK, CPM, OFX) were as follows: accordance rates: 91.62%, 99.16%, 96.93% and 96.37%; reproducibility: 99.16%, 99.16%, 94.96% and 94.12%; specificity: 99.12%, 99.64%, 98.00% and 98.41%; sensitivity: 78.03%, 97.62%, 94.44% and 91.51%. The accordance rates and sensitivity values of the four drugs showed statistically significant differences, while specificities showed no significant differences.
  
  
  CONCLUSIONS
  Eight (66.7%) participating laboratories met the set requirement criteria; however, DST in four (33.3%) laboratories requires greater attention. Of the four drugs tested, the results for KM were lower than those for the other drugs. External quality assessment can lead to effective evaluation of laboratory performance in SL DST.
authors.affiliation: National Tuberculosis Clinical Laboratory, Beijing Chest Hospital, Capital Medical University, Beijing, China.
authors.forename: G-L
authors.initials: GL
authors.lastname: Jiang
authors.forename: X
authors.initials: X
authors.lastname: Chen
authors.forename: Y
authors.initials: Y
authors.lastname: Song
authors.forename: Y
authors.initials: Y
authors.lastname: Zhao
authors.forename: H
authors.initials: H
authors.lastname: Huang
authors.forename: K M
authors.initials: KM
authors.lastname: Kam
mesh_terms: D000583:Amikacin / Q000627:therapeutic use; D000995:Antitubercular Agents / Q000627:therapeutic use*; D002207:Capreomycin / Q000627:therapeutic use; D002681:China; D024881:Drug Resistance, Bacterial; D006801:Humans; D007612:Kanamycin / Q000627:therapeutic use; D059021:Laboratory Proficiency Testing / Q000592:standards*; D008826:Microbial Sensitivity Tests / Q000592:standards*; D009169:Mycobacterium tuberculosis / Q000187:drug effects* / Q000254:growth & development; D015588:Observer Variation; D015242:Ofloxacin / Q000627:therapeutic use; D011237:Predictive Value of Tests; D011786:Quality Control; D019984:Quality Indicators, Health Care / Q000592:standards*; D015203:Reproducibility of Results; D014376:Tuberculosis / Q000175:diagnosis / Q000188:drug therapy* / Q000382:microbiology
chemical_list: D000995:Antitubercular Agents; D002207:Capreomycin; D007612:Kanamycin; D000583:Amikacin; D015242:Ofloxacin