Developmental roadmap for antimicrobial susceptibility testing systems

the JPIAMR AMR-RDT Working Group on Antimicrobial Resistance and Rapid Diagnostic Testing

    Research output: Contribution to journalArticlepeer-review

    110 Citations (Scopus)

    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.

    Original languageEnglish
    Pages (from-to)51-62
    Number of pages12
    JournalNature Reviews Microbiology
    Volume17
    Issue number1
    DOIs
    Publication statusPublished - 1 Jan 2019

    Bibliographical note

    Funding Information:
    This publication was made possible by a grant from the Joint Programming Initiative on Antimicrobial Resistance (JPIAMR), which was awarded to the Antimicrobial Resistance Rapid Diagnostic Tests (AMR-RDT) Working Group (JPIAMRWG-020). The authors thank M. Kaul, J. Tenllado, M. Finocchio and C. Sprugnoli (bioMérieux, France and USA) for insightful comments on quality systems, legal and registration aspects and intellectual property management.

    Publisher Copyright:
    © 2018, Springer Nature Limited.

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