Raising the Bar: Improving Antimicrobial Resistance Detection by Clinical Laboratories by Ensuring Use of Current Breakpoints.
Raising the Bar: Improving Antimicrobial Resistance Detection by Clinical Laboratories by Ensuring Use of Current Breakpoints.
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DOI：
10.1093/ofid/ofac007
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发表时间：
2022-03
影响因子：
4.2
通讯作者：
Humphries RM
中科院分区：
文献类型：
--
作者：
Simner PJ;Rauch CA;Martin IW;Sullivan KV;Rhoads D;Rolf R;She R;Souers RJ;Wojewoda C;Humphries RM
抗微生物药物耐药性（AMR）是临床实验室进行的抗微生物药物敏感性试验（AST）检测到的一项紧迫的全球挑战。AST结果使用临床断点进行解释，这些断点更新以准确检测新的和正在出现的AMR。不采用最新的断点的实验室阻碍了解决AMR危机的全球努力，但是人们对这种做法的程度知之甚少。共有1490个临床实验室参加了美国病理学家学院的细菌培养能力测试调查，以确定使用过时的断点。37.9%至70.5%的美国实验室报告对所查询的抗菌素使用了过时的断点。相比之下，只有17.7%-43.7%的国际实验室报告使用过时的断点（P < 0.05）。001)。当前断点的使用因AST系统而异，如果系统已通过美国食品和药物管理局的当前断点许可，则更多的实验室报告使用当前断点。在使用过时断点的实验室中，55.9%没有更新到当前标准的计划。引用的最常见原因是与制造商相关的问题（51.3%）和缺乏内部资源来进行分析验证研究以进行更新（23.4%）。13%的实验室表示他们不知道断点的变化或更新断点的需要。这些数据表明，美国在发现抗菌素耐药性方面存在重大差距，国际上的差距较小。临床实验室改进当前断点的应用将需要监管机构、实验室认可组织和设备制造商的联合行动。
Antimicrobial resistance (AMR) is a pressing global challenge detected by antimicrobial susceptibility testing (AST) performed by clinical laboratories. AST results are interpreted using clinical breakpoints, which are updated to enable accurate detection of new and emerging AMR. Laboratories that do not apply up-to-date breakpoints impede global efforts to address the AMR crisis, but the extent of this practice is poorly understood. A total of 1490 clinical laboratories participating in a College of American Pathologists proficiency testing survey for bacterial cultures were queried to determine use of obsolete breakpoints. Between 37.9% and 70.5% of US laboratories reported using obsolete breakpoints for the antimicrobials that were queried. In contrast, only 17.7%–43.7% of international laboratories reported using obsolete breakpoints (P < .001 for all comparisons). Use of current breakpoints varied by AST system, with more laboratories reporting use of current breakpoints in the US if the system had achieved US Food and Drug Administration clearance with current breakpoints. Among laboratories that indicated use of obsolete breakpoints, 55.9% had no plans to update to current standards. The most common reason cited was manufacturer-related issues (51.3%) and lack of internal resources to perform analytical validation studies to make the update (23.4%). Thirteen percent of laboratories indicated they were unaware of breakpoint changes or the need to update breakpoints. These data demonstrate a significant gap in the ability to detect AMR in the US, and to a lesser extent internationally. Improved application of current breakpoints by clinical laboratories will require combined action from regulatory agencies, laboratory accreditation groups, and device manufacturers.
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影响因子：
11.8
作者：
Dudley, Michael N.;Ambrose, Paul G.;Jones, Ronald N.
通讯作者：
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影响因子：
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作者：
Humphries, R. M.;Hindler, J. A.
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DOI：
10.1007/s10096-019-03711-y
发表时间：
2019-11-02
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