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Nat Rev Microbiol. 2019 Jan;17(1):51-62. doi: 10.1038/s41579-018-0098-9.

Developmental roadmap for antimicrobial susceptibility testing systems.

Author information

1
bioMérieux, Data Analytics Unit, La Balme Les Grottes, France. alex.vanbelkum@biomerieux.com.
2
The University of Edinburgh, Edinburgh Medical School, Division of Infection and Pathway Medicine, The Chancellor's Building, Edinburgh, UK.
3
Curetis GmbH, Holzgerlingen, Germany.
4
University of Copenhagen, Amager and Hvidovre Hospital, Department of Clinical Microbiology, Hvidovre, Denmark.
5
EUCAST Development Laboratory for Antimicrobial Susceptibility Testing, c/o Clinical Microbiology, Central Hospital, Växjö, Sweden.
6
bioMérieux, IT Solutions and Services, Durham, NC, USA.
7
University of Münster, Institute of Medical Microbiology, Münster, Germany.
8
Department of Medical Microbiology & Infectious Diseases, Erasmus University Medical Centre (Erasmus MC), Rotterdam, Netherlands.
9
NIS Laboratories, National Infection Service, Public Health England, London, UK.
10
Hahn-Schickard, Freiburg, Germany.
11
Department of Health Policy and Management, School of Public Health, Ben-Gurion University of the Negev, Beer-Sheva, Israel.
12
ESCMID Study Group for Genomic and Molecular Diagnostics (ESGMD), Basel, Switzerland.
13
University of Barcelona, School of Medicine, Clinical Microbiology, Hospital Clinic IS Global, 08036, Barcelona, Spain.
14
Fraunhofer IZI-BB, Potsdam, Germany.
15
F2G Ltd, Lankro Way, Eccles, Manchester, UK.
16
bioMérieux, Data Analytics Unit, 100 Rodolphe Street, Durham, NC, USA.

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.

PMID:
30333569
DOI:
10.1038/s41579-018-0098-9

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