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Developmental Roadmap for Antimicrobial Susceptibility Testing Systems
Alex van Belkum
Till T. Bachmann
Gerd Lüdke
Jan Gorm Lisby
Gunnar Kahlmeter
Allan Mohess
Karsten Becker
John P. Hays
Neil Woodford
Konstantinos Mitsakakis
Jacob Moran-Gilad
Jordi Vila
Harald Peter
John H. Rex
Michael Dunne
出版
Universität
, 2019
URL
http://books.google.com.hk/books?id=OYSZzwEACAAJ&hl=&source=gbs_api
註釋
Abstract: 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