National Reference Centre for Mycobacteria, Hôpital Pitié-Salpêtrière, AP-HP, and Université Pierre et Marie Curie, UNiversité Paris 06, Faculté de Médecine Pitié-Salpêtrière, Paris, France.
J Clin Microbiol. 2010 May;48(5):1683-9. doi: 10.1128/JCM.01947-09. Epub 2010 Mar 24.
The GenoType MTBDRsl test rapidly detects resistance to ethambutol, fluoroquinolones, and second-line aminoglycosides (amikacin and kanamycin) and cyclic peptide (capreomycin) in Mycobacterium tuberculosis. A set of 41 multidrug-resistant (MDR) M. tuberculosis strains, 8 extensively drug-resistant (XDR) M. tuberculosis strains, and 3 non-MDR M. tuberculosis strains were tested by the MTBDRsl test and by DNA sequencing of the resistance-determining regions in gyrA and gyrB (fluoroquinolones [FQ]), rpsL (streptomycin), rrs and tlyA (aminoglycosides and/or cyclic peptide), and embB (ethambutol). The sensitivity and specificity of the MTBDRsl test were as follows: 87% and 96%, respectively, for fluoroquinolones; 100% for both for amikacin; 77% and 100%, respectively, for kanamycin, 80% and 98%, respectively, for capreomycin; and 57% and 92%, respectively, for ethambutol. Analysis of the discrepant results indicated that three FQ-resistant strains (including one XDR strain) with mutations in gyrB were missed by the MTBDRsl test and that one FQ-susceptible strain, identified as resistant by the MTBDRsl test, had a double mutation (T80A-A90G) in GyrA that did not confer resistance to FQ. Five strains (including two XDR strains) without mutations in rrs were monoresistant to aminoglycosides or cyclic peptide and were missed by the MTBDRsl test. Finally, 12/28 ethambutol-resistant strains had no mutation at codon 306 in embB, while 2/24 ethambutol-susceptible strains had such a mutation. In conclusion, the MTBDRsl test efficiently detects the most common mutations involved in resistance to fluoroquinolones, aminoglycosides/cyclic peptide, and ethambutol and accurately assesses susceptibility to amikacin. However, due to mutations not included in the test (particularly in gyrB) or resistance mechanisms not yet characterized (particularly those related to ethambutol resistance and to monoresistance to aminoglycosides or cyclic peptide), the wild-type results yielded by the MTBDRsl test should be confirmed by drug susceptibility testing.
GenoType MTBDRsl 快速检测试剂盒可快速检测结核分枝杆菌对乙胺丁醇、氟喹诺酮类药物和二线氨基糖苷类药物（阿米卡星和卡那霉素）以及环肽（卷曲霉素）的耐药性。本研究采用 MTBDRsl 检测试剂盒和 DNA 测序方法，对 41 株耐多药（MDR）结核分枝杆菌、8 株广泛耐药（XDR）结核分枝杆菌和 3 株非 MDR 结核分枝杆菌的耐药决定区 gyrA 和 gyrB（氟喹诺酮类药物[FQ]）、rpsL（链霉素）、rrs 和 tlyA（氨基糖苷类和/或环肽）以及 embB（乙胺丁醇）的耐药基因突变进行了检测。MTBDRsl 检测试剂盒的灵敏度和特异性如下：FQ 分别为 87%和 96%；阿米卡星均为 100%；卡那霉素分别为 77%和 100%，卷曲霉素分别为 80%和 98%；乙胺丁醇分别为 57%和 92%。对不一致结果的分析表明，3 株 gyrB 基因突变的 FQ 耐药株（包括 1 株 XDR 株）漏检，1 株 MTBDRsl 检测为耐药的 FQ 敏感株，gyrA 存在双重突变（T80A-A90G），但未导致 FQ 耐药。5 株 rrs 无突变的菌株对氨基糖苷类或环肽单耐药，漏检 MTBDRsl 检测。最后，12/28 株乙胺丁醇耐药株 embB 密码子 306 无突变，而 2/24 株乙胺丁醇敏感株有突变。总之，MTBDRsl 检测试剂盒可有效检测与氟喹诺酮类、氨基糖苷类/环肽和乙胺丁醇耐药相关的最常见突变，并准确评估阿米卡星的敏感性。但是，由于未包括在检测中的突变（尤其是 gyrB 中的突变）或尚未确定的耐药机制（尤其是与乙胺丁醇耐药和对氨基糖苷类或环肽单耐药相关的耐药机制），MTBDRsl 检测试剂盒产生的野生型结果应通过药敏试验进行确认。
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