Developmental roadmap for antimicrobial susceptibility testing systems

• Published in: Nature reviews. Microbiology Vol. 17; no. 1; pp. 51 - 62
• Main Authors: van Belkum, Alex, Bachmann, Till T., Lüdke, Gerd, Lisby, Jan Gorm, Kahlmeter, Gunnar, Mohess, Allan, Becker, Karsten, Hays, John P., Woodford, Neil, Mitsakakis, Konstantinos, Moran-Gilad, Jacob, Vila, Jordi, Peter, Harald, Rex, John H., Dunne, Wm. Michael
• Format: Journal Article
• Language: English
• Published: London Nature Publishing Group UK 01.01.2019; Nature Publishing Group
• Subjects: 631/326/2521; 692/700; Anti-Bacterial Agents - pharmacology; Antibiotics; Antiinfectives and antibacterials; Antimicrobial agents; Automation; Bacteria - drug effects; Bacteria - genetics; Biomedical and Life Sciences; Clinical trials; Communicable diseases; Consensus Statement; Data analysis; Digital imaging; Drug resistance; Drug resistance in microorganisms; Evaluation; Examinations; Genomics; Global Health; Hospitals; Humans; Infectious Diseases; Laboratories; Life Sciences; Life span; Malalties infeccioses; Medical Microbiology; Medical research; Microbial sensitivity tests; Microbial Sensitivity Tests - methods; Microbiological research; Microbiology; New technology; Parasitology; Phenotyping; Practice guidelines (Medicine); Public health; Quality control; Reagents; Regulatory approval; Staphylococcus infections; Testing; Tests de sensibilitat microbiològica; Validity; Virology; France
• ISSN: 1740-1526; 1740-1534; 1740-1534
• 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. This Consensus Statement presents the barriers that currently prevent the timely development and implementation of novel and rapid antimicrobial susceptibility testing platforms, including the costs involved, uptake of new tools, legal and regulatory aspects, difficulties conducting clinical trials and quality control, and presents possible solutions.