title: [Evaluation of GenoType MTBDRplus for the detection of multi-drug-resistant Mycobacterium tuberculosis strains].
abstract: OBJECTIVE
  To evaluate GenoType MTBDRplus (Hain Lifescience, Germany) for its capacity to detect the resistance of rifampicin (RFP) and isoniazid (INH).
  
  
  METHODS
  A total of 44 confirmed multi-drug resistant (MDR) and 67 susceptible M. tuberculosis strains were tested for susceptibility to RFP and INH by GenoType MTBDR plus. The core 81bp region of the rpoB gene and the 322bp region of the katG gene and the inhA gene (248bp of which included the promoter and the ORF of the 379bp inhA) were directly sequenced for both MDR-TB and susceptible M. tuberculosis strains, and the mutations were confirmed. Susceptibility was tested by standard proportion method with 1% Ogawa medium.
  
  
  RESULTS
  The sensitivities of GenoType MTBDRplus for RFP and INH resistance were 97.7% and 65.9%, respectively. The specificity for RFP and INH was 100%. The sensitivity of GenoType MTBDRplus was almost equivalent to the sequencing method for RFP, but that for INH was slightly inferior to the sequencing without significant difference. Geno Type MTBDRplus detected 97.7% of the mutations of rpoB compared with the direct sequencing. It also detected 24 katG MUT1 (S315T1) (54.5%) and 5 inhA MUT1 (C15T) mutations (11.4%), while the direct sequencing detected an additional 2 (4.5%) katG mutants.
  
  
  CONCLUSIONS
  The accuracy of GenoType MTBDRplus for the detection of RFP resistance was confirmed to be comparable to that of DST using conventional culture-based methods, while it was less accurate for detection of INH resistance. GenoType MTBDRplus is useful for early diagnosis and infection control for MDR-TB because it has a short turnaround time of approximately 6 hours.
authors.affiliation: Bacteriology Division, Department of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Tokyo, Japan.
authors.forename: Kinuyo
authors.initials: K
authors.lastname: Chikamatsu
authors.forename: Kazue
authors.initials: K
authors.lastname: Mizuno
authors.forename: Akio
authors.initials: A
authors.lastname: Aono
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Yamada
authors.forename: Tetsuhiro
authors.initials: T
authors.lastname: Sugamoto
authors.forename: Hiroyuki
authors.initials: H
authors.lastname: Nishiyama
authors.forename: Satoshi
authors.initials: S
authors.lastname: Mitarai
mesh_terms: D000904:Antibiotics, Antitubercular / Q000494:pharmacology*; D000995:Antitubercular Agents / Q000494:pharmacology*; D004269:DNA, Bacterial / Q000302:isolation & purification; D005838:Genotype; D007538:Isoniazid / Q000494:pharmacology*; D008826:Microbial Sensitivity Tests; D009169:Mycobacterium tuberculosis / Q000187:drug effects* / Q000235:genetics; D021141:Nucleic Acid Amplification Techniques; D009693:Nucleic Acid Hybridization; D012293:Rifampin / Q000494:pharmacology*; D018088:Tuberculosis, Multidrug-Resistant / Q000382:microbiology*
chemical_list: D000904:Antibiotics, Antitubercular; D000995:Antitubercular Agents; D004269:DNA, Bacterial; D007538:Isoniazid; D012293:Rifampin