Emerging Resistance, New Antimicrobial Agents ... but No Tests! The Challenge of Antimicrobial Susceptibility Testing in the Current US Regulatory Landscape
Emerging Resistance, New Antimicrobial Agents ... but No Tests! The Challenge of Antimicrobial Susceptibility Testing in the Current US Regulatory Landscape
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DOI：
10.1093/cid/ciw201
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发表时间：
2016-07-01
影响因子：
11.8
通讯作者：
Hindler, J. A.
中科院分区：
文献类型：
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作者：
Humphries, R. M.;Hindler, J. A.
临床实验室准确、及时地开展抗微生物药敏试验（AST）对防治抗微生物药物耐药性至关重要。美国实验室有效执行ast的能力受到几个因素的挑战。有些是不可避免的，例如新的抗性机制和相关的测试建议和断点的演变。其他的则完全是人造的。这些问题包括美国食品和药物管理局（FDA）对商用AST系统用于诊断测试的严格限制，这些系统缺乏最新的性能数据，以及缺乏针对较新的抗菌药物或具有更新断点的较旧药物的市售FDA批准的测试。这一观点将突出当前临床实验室面临的AST挑战，并提出一些解决方案。
Accurate and timely performance of antimicrobial susceptibility testing (AST) by the clinical laboratory is paramount to combating antimicrobial resistance. The ability of laboratories in the United States to effectively perform ASTs is challenged by several factors. Some, such as new resistance mechanisms and the associated evolution of testing recommendations and breakpoints, are inevitable. Others are entirely man-made. These include unnecessarily strict US Food and Drug Administration (FDA) limitations on how commercial AST systems can be used for diagnostic testing, the absence of up-to-date performance data on these systems, and the lack of commercially available FDA-cleared tests for newer antimicrobial agents or for older agents with updated breakpoints. This viewpoint will highlight contemporary AST challenges faced by the clinical laboratory, and propose some solutions.