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Twenty-first Century Cures Act and Antimicrobial Susceptibility Testing: Clinical Implications in the Era of Multidrug Resistance
Clinical Infectious Diseases ( IF 8.2 ) Pub Date : 2018-05-23 , DOI: 10.1093/cid/ciy432
Romney M Humphries 1 , Janet Hindler 2 , Mary Jane Ferraro 3 , Amy Mathers 4, 5
Affiliation  

Clinical laboratories act at the frontline of identification of infections caused by multidrug-resistant organisms, and yet the tools they apply are often woefully out of date. Incomplete adoption of current testing standards, updated breakpoints, and tests for new drugs across laboratories has been exacerbated by lack of coordination between standards development organizations (SDOs), pharmaceutical companies, susceptibility test manufacturers, and the US Food and Drug Administration. The 21st Century Cures Act includes provisions to enable alignment between these groups by (1) allowing recognition of breakpoints set by qualified SDOs; (2) publicly posting recognized breakpoints; and (3) reviewing breakpoints for necessary updates, every 6 months. Combined, these provisions will ensure more rapid recognition of current breakpoints, improving detection and management of resistant infections. Although several limitations remain, this will ultimately allow susceptibility test manufacturers to more readily update to current breakpoints.

中文翻译:

二十一世纪治愈法和抗菌药物敏感性试验:多重耐药性时代的临床意义

临床实验室在鉴定由多重耐药性生物引起的感染方面处于最前沿,然而,它们所使用的工具却常常过时了。由于标准制定组织(SDO),制药公司,药敏试验制造商和美国食品与药物管理局之间缺乏协调,加剧了当前不完全采用当前的检验标准,更新的断点和跨实验室对新药进行检验的情况。《 21世纪治愈法案》包括以下方面的规定:(1)允许认可合格的SDO设置的断点;(2)公开发布公认的断点;(3)每6个月检查一次断点以进行必要的更新。这些规定加在一起,将确保更快速地识别当前的断点,改善对耐药性感染的检测和管理。尽管仍然存在一些局限性,但这最终将使敏感性测试制造商更容易更新到当前的断点。
更新日期:2018-09-15
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