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Developmental roadmap for antimicrobial susceptibility testing systems.

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Rapid antimicrobial susceptibility testing (AST) platforms face barriers to development and implementation. This consensus statement identifies challenges and proposes solutions for advancing AST technology in healthcare settings.

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Area of Science:

  • Clinical Microbiology
  • Infectious Diseases
  • Medical Technology

Background:

  • Antimicrobial susceptibility testing (AST) is crucial for targeted antimicrobial therapy and antimicrobial stewardship.
  • Despite advancements in phenotyping, imaging, and genomics, a major breakthrough in rapid AST platforms is lacking.
  • Barriers hinder the timely development and clinical adoption of novel rapid AST technologies.

Purpose of the Study:

  • To identify and analyze the barriers preventing the development and implementation of rapid AST platforms.
  • To propose potential solutions for overcoming these identified challenges.

Main Methods:

  • This consensus statement synthesizes expert opinion and literature review.
  • Key barriers discussed include technological validation, regulatory pathways, cost-effectiveness, and clinical utility.
  • The document also addresses reagent stability, quality control, and clinical trial design.

Main Results:

  • Multiple factors impede rapid AST platform adoption, including complex validation processes and regulatory hurdles.
  • Economic factors, user uptake, and technical challenges like reagent stability are significant obstacles.
  • Successful implementation requires addressing target product profiles and quality assurance.

Conclusions:

  • Overcoming barriers in validation, regulation, cost, and implementation is essential for advancing rapid AST.
  • Addressing these multifaceted challenges will facilitate the clinical integration of novel AST technologies.
  • Collaborative efforts are needed to accelerate the development and deployment of effective rapid AST solutions.