UCLA Health System, Los Angeles, California, USA.
Indiana University School of Medicine, Indianapolis, Indiana, USA.
J Clin Microbiol. 2021 Feb 18;59(3). doi: 10.1128/JCM.01870-20.
In this multisite study, Vitek 2 AST-Gram-Negative Ceftazidime/Avibactam test results for 1,073 isolates (866 and 207 ) were compared to the Clinical and Laboratory Standards Institute (CLSI) broth microdilution (BMD) reference method. The results were analyzed for essential agreement (EA), category agreement (CA), major error rates, and very major error rates following FDA/ISO performance criteria using the FDA-recognized CLSI/EUCAST breakpoints (sensitive [S], ≤8/4 μg/ml; resistant [R], ≥16/4 μg/ml). The overall EA was 94.5% (1,014/1,073) and CA was 98.7% (1,059/1,073). No very major errors were reported. The major error rate was 1.4% (14/998). Out of 14 major errors, 9 were within EA. Based on the EA and lack of an intermediate category for ceftazidime-avibactam (CZA), the adjusted major error rate for FDA criteria was 0.5% (5/998). The performance for ISO criteria after error resolutions included EA of 94.5% (1,014/1,073), CA of 98.9% (1,061/1,073), major error of 1.2% (12/998), and no very major error. Vitek 2 met the ISO and FDA criteria of ≥95% reproducibility and ≥95% quality control (QC) results within acceptable ranges for QC organisms. Vitek 2 overall performance for and met or exceeded the FDA and ISO performance criteria; thus, it is a reliable alternative to the BMD reference method for routine CZA susceptibility testing.
在这项多中心研究中，比较了 Vitek 2 AST-Gram-Negative Ceftazidime/Avibactam 测试结果，该结果来自 1073 株分离株（866 株和 207 株），与临床和实验室标准协会（CLSI）肉汤微量稀释（BMD）参考方法进行比较。根据 FDA/ISO 性能标准，使用 FDA 认可的 CLSI/EUCAST 折点（敏感 [S]，≤8/4μg/ml；耐药 [R]，≥16/4μg/ml），对基本符合率（EA）、类别符合率（CA）、主要错误率和非常主要错误率进行了分析。总体 EA 为 94.5%（1014/1073），CA 为 98.7%（1059/1073）。没有报告非常主要的错误。主要错误率为 1.4%（14/998）。在 14 个主要错误中，9 个在 EA 范围内。根据 EA 和缺乏头孢他啶-阿维巴坦（CZA）的中间类别，根据 FDA 标准，调整后的主要错误率为 0.5%（5/998）。错误解决后，ISO 标准的性能包括 EA 为 94.5%（1014/1073）、CA 为 98.9%（1061/1073）、主要错误率为 1.2%（12/998）和无非常主要错误。Vitek 2 符合 ISO 和 FDA 标准，即≥95%的重现性和≥95%的质量控制（QC）结果，QC 菌落在可接受范围内。Vitek 2 对 和 的整体性能符合或超过了 FDA 和 ISO 的性能标准；因此，它是 BMD 参考方法用于常规 CZA 药敏试验的可靠替代方法。
