title: Evaluation of the GenoType(®) MTBDRplus line probe assay on sputum-positive samples in routine settings in China.
abstract: BACKGROUND
  Rapid molecular methods have been recommended for early detection of drug-resistant tuberculosis (TB).
  
  
  OBJECTIVE
  To evaluate the performance of the GenoType(®) MTBDRplus assay in routine settings in China.
  
  
  METHODS
  Sputum-positive samples were collected consecutively from 1 April to 31 December 2010. MTBDRplus results were compared to those of conventional drug susceptibility testing (DST). The McNemar χ(2) test and κ coefficient were used to assess performance.
  
  
  RESULTS
  Of 427 smear-positive sputum samples collected, conventional DST and MTBDTplus confirmed drug resistance in 326. The sensitivities and specificities for MTBDRplus in detecting isoniazid (INH) and rifampicin (RMP) resistance were respectively 76.47%, 95.44%, 85.94% and 93.13%. The McNemar χ(2) test indicated no significant difference between the two methods (P = 0.106 for INH and P = 0.083 for RMP). The κ values for INH, RMP and multidrug resistance were respectively 0.75, 0.75 and 0.70.
  
  
  CONCLUSIONS
  Although the MTBDRplus assay was moderately concordant with conventional DST in detecting INH and RMP resistance, as a prospective rapid molecular method for MDR-TB detection, potential resistant mutations need to be incorporated to improve the accuracy of detection.
authors.affiliation: Department of Chronic Communicable Disease, Center for Disease Control and Prevention of Jiangsu Province, Nanjing, China; School of Public Health, Fudan University, Shanghai, China.
authors.forename: C
authors.initials: C
authors.lastname: Chen
authors.affiliation: Department of Chronic Communicable Disease, Center for Disease Control and Prevention of Jiangsu Province, Nanjing, China.
authors.forename: W
authors.initials: W
authors.lastname: Kong
authors.affiliation: Department of Chronic Communicable Disease, Center for Disease Control and Prevention of Jiangsu Province, Nanjing, China.
authors.forename: L
authors.initials: L
authors.lastname: Zhu
authors.affiliation: Department of Chronic Communicable Disease, Center for Disease Control and Prevention of Jiangsu Province, Nanjing, China.
authors.forename: Y
authors.initials: Y
authors.lastname: Zhou
authors.affiliation: Department of Chronic Communicable Disease, Center for Disease Control and Prevention of Jiangsu Province, Nanjing, China.
authors.forename: H
authors.initials: H
authors.lastname: Peng
authors.affiliation: Department of Chronic Communicable Disease, Center for Disease Control and Prevention of Jiangsu Province, Nanjing, China.
authors.forename: Y
authors.initials: Y
authors.lastname: Shao
authors.affiliation: Department of Chronic Communicable Disease, Center for Disease Control and Prevention of Jiangsu Province, Nanjing, China.
authors.forename: H
authors.initials: H
authors.lastname: Song
authors.affiliation: Department of Chronic Communicable Disease, Center for Disease Control and Prevention of Jiangsu Province, Nanjing, China.
authors.forename: Q
authors.initials: Q
authors.lastname: Liu
authors.affiliation: Department of Chronic Communicable Disease, Center for Disease Control and Prevention of Jiangsu Province, Nanjing, China.
authors.forename: G
authors.initials: G
authors.lastname: Li
authors.affiliation: The Fourth People's Hospital of Lianyungang City, Lianyungang, China.
authors.forename: J
authors.initials: J
authors.lastname: Shi
authors.affiliation: Center for Disease Control and Prevention of Lianyungang City, Lianyungang, Jiangsu Province, China.
authors.forename: C
authors.initials: C
authors.lastname: Zhong
authors.affiliation: Center for Disease Control and Prevention of Lianyungang City, Lianyungang, Jiangsu Province, China.
authors.forename: L
authors.initials: L
authors.lastname: Zhu
authors.affiliation: Department of Chronic Communicable Disease, Center for Disease Control and Prevention of Jiangsu Province, Nanjing, China.
authors.forename: X
authors.initials: X
authors.lastname: Ding
authors.affiliation: Department of Chronic Communicable Disease, Center for Disease Control and Prevention of Jiangsu Province, Nanjing, China.
authors.forename: H
authors.initials: H
authors.lastname: Yu
authors.affiliation: Department of Chronic Communicable Disease, Center for Disease Control and Prevention of Jiangsu Province, Nanjing, China.
authors.forename: H
authors.initials: H
authors.lastname: Yang
authors.affiliation: Department of Chronic Communicable Disease, Center for Disease Control and Prevention of Jiangsu Province, Nanjing, China.
authors.forename: W
authors.initials: W
authors.lastname: Lu
mesh_terms: D000995:Antitubercular Agents / Q000627:therapeutic use; D001431:Bacteriological Techniques; D016009:Chi-Square Distribution; D002681:China; D004252:DNA Mutational Analysis; D004269:DNA, Bacterial / Q000302:isolation & purification*; D024901:Drug Resistance, Multiple, Bacterial / Q000235:genetics; D042241:Early Diagnosis; D006801:Humans; D007538:Isoniazid / Q000627:therapeutic use; D008826:Microbial Sensitivity Tests; D025202:Molecular Diagnostic Techniques; D009154:Mutation; D009169:Mycobacterium tuberculosis / Q000187:drug effects / Q000235:genetics / Q000302:isolation & purification*; D011237:Predictive Value of Tests; D011379:Prognosis; D015203:Reproducibility of Results; D012293:Rifampin / Q000627:therapeutic use; D013183:Sputum / Q000382:microbiology; D018088:Tuberculosis, Multidrug-Resistant / Q000175:diagnosis* / Q000188:drug therapy / Q000382:microbiology; D014397:Tuberculosis, Pulmonary / Q000175:diagnosis* / Q000188:drug therapy / Q000382:microbiology
chemical_list: D000995:Antitubercular Agents; D004269:DNA, Bacterial; D007538:Isoniazid; D012293:Rifampin