bioMérieux, Data Analytics Unit, La Balme Les Grottes, France.
The University of Edinburgh, Edinburgh Medical School, Division of Infection and Pathway Medicine, The Chancellor's Building, Edinburgh, UK.
Nat Rev Microbiol. 2019 Jan;17(1):51-62. doi: 10.1038/s41579-018-0098-9.
Antimicrobial susceptibility testing (AST) technologies help to accelerate the initiation of targeted antimicrobial therapy for patients with infections and could potentially extend the lifespan of current narrow-spectrum antimicrobials. Although conceptually new and rapid AST technologies have been described, including new phenotyping methods, digital imaging and genomic approaches, there is no single major, or broadly accepted, technological breakthrough that leads the field of rapid AST platform development. This might be owing to several barriers that prevent the timely development and implementation of novel and rapid AST platforms in health-care settings. In this Consensus Statement, we explore such barriers, which include the utility of new methods, the complex process of validating new technology against reference methods beyond the proof-of-concept phase, the legal and regulatory landscapes, costs, the uptake of new tools, reagent stability, optimization of target product profiles, difficulties conducting clinical trials and issues relating to quality and quality control, and present possible solutions.
抗菌药物敏感性检测（AST）技术有助于加快为感染患者启动靶向抗菌治疗，并可能延长现有窄谱抗菌药物的使用寿命。虽然已经描述了新概念和快速 AST 技术，包括新的表型方法、数字成像和基因组方法，但目前还没有一项重大的、被广泛接受的技术突破来引领快速 AST 平台的发展。这可能是由于存在一些障碍，这些障碍阻止了新型和快速 AST 平台在医疗保健环境中的及时开发和实施。在本共识声明中，我们探讨了这些障碍，包括新方法的实用性、在证明概念阶段之外针对参考方法验证新技术的复杂过程、法律和监管环境、成本、新工具的采用、试剂稳定性、目标产品特性的优化、临床试验的困难以及与质量和质量控制相关的问题，并提出了可能的解决方案。
