Chikamatsu Kinuyo, Mizuno Kazue, Aono Akio, Yamada Hiroyuki, Sugamoto Tetsuhiro, Nishiyama Hiroyuki, Mitarai Satoshi
Bacteriology Division, Department of Mycobacterium Reference and Research, Research Institute of Tuberculosis, Japan Anti-Tuberculosis Association, Tokyo, Japan.
Kekkaku. 2011 Jul;86(7):697-702.
To evaluate GenoType MTBDRplus (Hain Lifescience, Germany) for its capacity to detect the resistance of rifampicin (RFP) and isoniazid (INH).
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.
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.
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.
评估GenoType MTBDRplus（德国海因生命科学公司）检测利福平（RFP）和异烟肼（INH）耐药性的能力。
采用GenoType MTBDR plus对44株确诊的耐多药（MDR）结核分枝杆菌菌株和67株敏感结核分枝杆菌菌株进行RFP和INH药敏试验。对MDR-TB菌株和敏感结核分枝杆菌菌株的rpoB基因核心81bp区域、katG基因322bp区域及inhA基因（其中248bp包括启动子和379bp inhA的开放阅读框）进行直接测序，并对突变进行确认。采用1%小川培养基的标准比例法检测药敏性。
GenoType MTBDRplus对RFP和INH耐药性的敏感性分别为97.7%和65.9%。对RFP和INH的特异性均为100%。GenoType MTBDRplus对RFP的敏感性与测序方法相近，但对INH的敏感性略低于测序方法，差异无统计学意义。与直接测序相比，GenoType MTBDRplus检测到rpoB基因97.7%的突变。还检测到24个katG MUT1（S315T1）突变（54.5%）和5个inhA MUT1（C15T）突变（11.4%），而直接测序还检测到另外2个（4.5%）katG突变体。
GenoType MTBDRplus检测RFP耐药性的准确性经证实与传统基于培养的方法相当，而检测INH耐药性的准确性较低。GenoType MTBDRplus对于MDR-TB的早期诊断和感染控制很有用，因为其周转时间约为6小时，较短。
