Accelerate Diagnostics, Tucson, Arizona, USA
Becton, Dickinson and Company, Sparks, Maryland, USA.
J Clin Microbiol. 2018 Jul 26;56(8). doi: 10.1128/JCM.00437-18. Print 2018 Aug.
Expedited pathways to antimicrobial agent approval by the U.S. Food and Drug Administration (FDA) have led to increased delays between drug approval and the availability of FDA-cleared antimicrobial susceptibility testing (AST) devices. Antimicrobial disks for use with disk diffusion testing are among the first AST devices available to clinical laboratories. However, many laboratories are reluctant to implement disk diffusion testing for a variety of reasons, including dwindling proficiency with this method, interruptions of the laboratory workflow, uncertainty surrounding the quality and reliability of disk diffusion tests, and a perceived need to report MIC values to clinicians. This minireview provides a report from the Clinical and Laboratory Standards Institute Methods Development and Standardization Working Group on the current standards and clinical utility of disk diffusion testing.
美国食品和药物管理局 (FDA) 加快了抗菌药物审批途径,导致药物批准和获得 FDA 批准的抗菌药物敏感性检测 (AST) 设备之间的延迟增加。用于扩散盘测试的抗菌药敏纸片是最早可用于临床实验室的 AST 设备之一。然而,许多实验室出于各种原因不愿实施扩散盘测试,包括这种方法的熟练程度下降、实验室工作流程中断、对扩散盘测试的质量和可靠性的不确定性,以及认为需要向临床医生报告 MIC 值。这篇综述提供了来自临床和实验室标准协会方法开发和标准化工作组的报告,介绍了扩散盘测试的当前标准和临床应用。