Pathology, Microbiology and Immunology, Vanderbilt University Medical Center, Nashville, Tennessee, USA.
CMID Pharma Consulting, LLC, Dresher, Pennsylvania, USA.
J Clin Microbiol. 2023 Jun 20;61(6):e0188622. doi: 10.1128/jcm.01886-22. Epub 2023 Mar 27.
Antibacterial susceptibility testing (AST) is performed to guide therapy, perform resistance surveillance studies, and support development of new antibacterial agents. For 5 decades, broth microdilution (BMD) has served as the reference method to assess activity of antibacterial agents against which both novel agents and diagnostic tests have been measured. BMD relies on in vitro inhibition or killing of bacteria. It is associated with several limitations: it is a poor mimic of the milieu of bacterial infections, requires multiple days to perform, and is associated with subtle, difficult to control variability. In addition, new reference methods will soon be needed for novel agents whose activity cannot be evaluated by BMD (e.g., those that target virulence). Any new reference methods must be standardized, correlated with clinical efficacy and be recognized internationally by researchers, industry, and regulators. Herein, we describe current reference methods for in vitro assessment of antibacterial activity and highlight key considerations for the generation of novel reference methods.
抗菌药物敏感性测试（AST）用于指导治疗、进行耐药监测研究，并支持新型抗菌药物的开发。50 年来，肉汤微量稀释法（BMD）一直是评估新型抗菌药物和诊断检测试剂抗菌活性的参考方法。BMD 依赖于体外抑制或杀灭细菌。它存在一些局限性：它不能很好地模拟细菌感染的环境，需要多天才能完成，并且存在细微、难以控制的变异性。此外，对于那些不能通过 BMD 评估活性的新型药物（例如，针对毒力的药物），很快就需要新的参考方法。任何新的参考方法都必须标准化，与临床疗效相关，并得到研究人员、行业和监管机构的国际认可。本文描述了目前用于体外评估抗菌活性的参考方法，并强调了生成新型参考方法的关键考虑因素。
