In this multisite study, Vitek 2 AST-Gram-Negative Ceftazidime/Avibactam test results for 1,073 isolates (866 Enterobacterales and 207 Pseudomonas aeruginosa) 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 Enterobacterales and P. aeruginosa 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.

中文翻译：

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在 Vitek 2 系统上对肠杆菌属和铜绿假单胞菌进行头孢他啶-阿维巴坦药敏试验的多中心评估

在这项多中心研究中，Vitek 2 AST-革兰氏阴性头孢他啶/阿维巴坦对 1,073 株分离株（866 株肠杆菌属和 207株铜绿假单胞菌）的检测结果) 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 断点（敏感 [S]，≤8/ 4 μg/ml；抗性 [R]，≥16/4 μg/ml）。总 EA 为 94.5% (1,014/1,073)，CA 为 98.7% (1,059/1,073)。没有报告非常重大的错误。主要错误率为 1.4% (14/998)。在 14 个主要错误中，有 9 个在 EA 内。基于 EA 和缺乏头孢他啶-阿维巴坦 (CZA) 的中间类别，FDA 标准的调整后主要错误率为 0.5% (5/998)。错误解决后 ISO 标准的性能包括 94.5% (1,014/1,073) 的 EA，98.9% (1,061/1,073) 的 CA，1.2% (12/998) 的主要错误，并且没有非常大的错误。Vitek 2 符合 ISO 和 FDA 标准，即在 QC 生物体可接受的范围内，≥95% 的重现性和 ≥95% 的质量控制 (QC) 结果。Vitek 2 整体性能肠杆菌属和铜绿假单胞菌达到或超过 FDA 和 ISO 性能标准；因此，它是用于常规 CZA 敏感性测试的 BMD 参考方法的可靠替代方法。