比较 Vitek 2 酵母菌药敏系统与 CLSI 微量稀释法对氟康唑和伏立康唑抗念珠菌属的药敏试验，采用新的临床折点和流行病学切点值。
Comparison of the Vitek 2 yeast susceptibility system with CLSI microdilution for antifungal susceptibility testing of fluconazole and voriconazole against Candida spp., using new clinical breakpoints and epidemiological cutoff values.
机构信息
University of Iowa College of Medicine, Iowa City, IA 52242, USA.
出版信息
Diagn Microbiol Infect Dis. 2013 Sep;77(1):37-40. doi: 10.1016/j.diagmicrobio.2013.05.019. Epub 2013 Jul 16.
A commercially available, fully automated yeast susceptibility test system (Vitek 2; bioMérieux, Marcy d'Etoile, France) was compared in 3 different laboratories with the Clinical and Laboratory Standards Institute (CLSI) reference microdilution (BMD) method by testing 2 quality control strains, 10 reproducibility strains, and 425 isolates of Candida spp. against fluconazole and voriconazole. Reference CLSI BMD MIC endpoints and Vitek 2 MIC endpoints were read after 24 hours and 9.1-27.1 hours incubation, respectively. Excellent essential agreement (within 2 dilutions) between the reference and Vitek 2 MICs was observed for fluconazole (97.9%) and voriconazole (96.7%). Categorical agreement (CA) between the 2 methods was assessed using the new species-specific clinical breakpoints (CBPs): susceptible (S) ≤2 μg/mL, susceptible dose-dependent (SDD) 4 μg/mL, and resistant (R) ≥8 μg/mL for fluconazole and Candida albicans, Candida tropicalis, and Candida parapsilosis and ≤32 μg/mL (SDD), ≥64 μg/mL (R) for Candida glabrata; S ≤0.12 μg/mL, SDD 0.25-0.5 μg/mL, R ≥1 μg/mL for voriconazole and C. albicans, C. tropicalis, and C. parapsilosis, and ≤0.5 μg/mL (S), 1 μg/mL (SDD), ≥2 μg/mL (R) for Candida krusei. The epidemiological cutoff value (ECV) of 0.5 μg/mL for voriconazole and C. glabrata was used to differentiate wild-type (WT; MIC ≤ ECV) from non-WT (MIC > ECV) strains of this species. Due to the lack of CBPs for the less common species, the ECVs for fluconazole and voriconazole, respectively, were used for Candida lusitaniae (2 μg/mL and 0.03 μg/mL), Candida dubliniensis (0.5 μg/mL and 0.03 μg/mL), Candida guilliermondii (8 μg/mL and 0.25 μg/mL), and Candida pelliculosa (4 μg/mL and 0.25 μg/mL) to categorize isolates of these species as WT and non-WT. CA between the 2 methods was 96.8% for fluconazole and 96.5% for voriconazole with less than 1% very major errors and 1.3-3.0% major errors. The Vitek 2 yeast susceptibility system remains comparable to the CLSI BMD reference method for testing the susceptibility of Candida spp. when using the new (lower) CBPs and ECVs.
一种市售的全自动酵母药敏测试系统（Vitek 2；生物梅里埃，马西德埃托伊尔，法国）在 3 个不同的实验室中与临床和实验室标准协会（CLSI）参考微量稀释（BMD）方法进行了比较，使用 2 种质控菌株、10 种重现性菌株和 425 株念珠菌属。对氟康唑和伏立康唑进行测试。参考 CLSI BMD MIC 终点和 Vitek 2 MIC 终点分别在 24 小时和 9.1-27.1 小时孵育后读取。观察到氟康唑（97.9%）和伏立康唑（96.7%）参考和 Vitek 2 MIC 之间具有极好的基本一致性（相差 2 个稀释度）。使用新的种特异性临床折点（CBP）评估 2 种方法的分类一致性（CA）：氟康唑对白色念珠菌、热带念珠菌和近平滑念珠菌的敏感（S）≤2μg/mL，敏感剂量依赖性（SDD）4μg/mL，耐药（R）≥8μg/mL，而对光滑念珠菌的敏感（S）≤32μg/mL（SDD），耐药（R）≥64μg/mL；伏立康唑对白色念珠菌、热带念珠菌和近平滑念珠菌的敏感（S）≤0.12μg/mL，敏感剂量依赖性（SDD）0.25-0.5μg/mL，耐药（R）≥1μg/mL，而对克柔念珠菌的敏感（S）≤0.5μg/mL（SDD），耐药（R）≥1μg/mL。氟康唑和克柔念珠菌的 0.5μg/mL 为伏立康唑的流行病学截断值（ECV），用于区分野生型（WT；MIC≤ECV）和非野生型（MIC＞ECV）菌株。由于缺乏较少见物种的 CBP，因此分别使用氟康唑和伏立康唑的 ECV 来对葡萄牙念珠菌（2μg/mL 和 0.03μg/mL）、都柏林念珠菌（0.5μg/mL 和 0.03μg/mL）、季也蒙念珠菌（8μg/mL 和 0.25μg/mL）和pelliculosa 念珠菌（4μg/mL 和 0.25μg/mL）进行分类，将这些物种的分离物归类为 WT 和非 WT。氟康唑的 CA 为 96.8%，伏立康唑的 CA 为 96.5%，小于 1%的非常大误差和 1.3-3.0%的大误差。当使用新的（较低）CBP 和 ECV 时，Vitek 2 酵母药敏系统仍然可以与 CLSI BMD 参考方法相媲美，用于测试念珠菌属的药敏性。
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