Long Story Short: Establishing Breakpoints for Antimicrobials and 2023 Updates

IF 3.1 4区医学 Q2 INFECTIOUS DISEASES

Current Infectious Disease Reports Pub Date : 2024-01-18 DOI:10.1007/s11908-024-00830-2

Morgan L. Bixby, Dina Zheng, Elizabeth B. Hirsch

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Abstract

Purpose of Review

This review outlines the process of setting and revising Clinical and Laboratory Standards Institute (CLSI) breakpoints and summarizes breakpoints approved in 2023. These breakpoints will be published in the 2024 edition of the CLSI M100 document.

Recent Findings

Over the past decade, new rapid diagnostic tests and antibiotic approvals have led to more frequent updates and revisions to clinical breakpoints—or susceptibility test interpretive criteria (STIC). CLSI is currently the only recognized standards development organization—outside of the FDA—allowed to set or revise STIC. The process of setting breakpoints is not always clear-cut because data evaluation can be limited by a lack of published data in one of three required categories (microbiologic, pharmacokinetic/pharmacodynamics, and clinical outcomes) detailed in the CLSI M23 document.

Summary

Antimicrobial susceptibility testing is a foundation for optimal antimicrobial therapy and plays a critical role in monitoring the spread of antimicrobial resistance.

Abstract Image

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长话短说：确定抗菌药物的断点和 2023 年更新

综述目的本综述概述了临床和实验室标准协会（CLSI）断点的设定和修订过程，并总结了 2023 年批准的断点。这些断点将在 2024 年版的 CLSI M100 文件中公布。最新发现在过去十年中，新的快速诊断检测和抗生素的批准导致临床断点或药敏试验解释性标准（STIC）的更新和修订更加频繁。目前，除美国食品及药物管理局外，CLSI 是唯一获准制定或修订 STIC 的公认标准制定组织。设定断点的过程并不总是一目了然的，因为在 CLSI M23 文件详述的三个必要类别（微生物学、药动学/药效学和临床结果）中，如果缺乏其中一个类别的已发表数据，数据评估就会受到限制。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Current Infectious Disease Reports INFECTIOUS DISEASES-

CiteScore

6.70

自引率

0.00%

发文量

期刊介绍： This journal intends to provide clear, insightful, balanced contributions by international experts that review the most important, recently published clinical findings related to the diagnosis, treatment, management, and prevention of infectious disease. We accomplish this aim by appointing international authorities to serve as Section Editors in key subject areas, such as HIV/AIDS, sexually transmitted diseases, tropical and travel medicine, and urinary tract infections. Section Editors, in turn, select topics for which leading experts contribute comprehensive review articles that emphasize new developments and recently published papers of major importance, highlighted by annotated reference lists.