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MASTERMIND: Bringing Microbial Diagnostics to the Clinic.

Robin Patel1, Ephraim L Tsalik2, Elizabeth Petzold2

  • 1Division of Clinical Microbiology, Department of Laboratory Medicine and Pathology, and Division of Infectious Diseases, Department of Medicine, Mayo Clinic, Rochester, Minnesota; patel.robin@mayo.edu.

Clinical Infectious Diseases : an Official Publication of the Infectious Diseases Society of America
|December 9, 2016
PubMed
Summary
This summary is machine-generated.

New diagnostic strategies are essential for combating antimicrobial resistance. The MASTERMIND protocol streamlines the evaluation of multiple infection diagnostics using single samples for FDA clearance.

Keywords:
communicable diseasesmolecular diagnostic techniquesreference standards.

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Area of Science:

  • Infectious Diseases
  • Diagnostic Development
  • Antimicrobial Resistance

Background:

  • Emerging antimicrobial resistance necessitates novel diagnostic solutions.
  • Conventional trial designs present challenges in advancing infectious disease diagnostics.
  • The Antibacterial Resistance Leadership Group (ARLG) seeks to overcome these hurdles.

Purpose of the Study:

  • To introduce the MASTERMIND (Master Protocol for Evaluating Multiple Infection Diagnostics) strategy.
  • To outline how MASTERMIND facilitates the generation of data for FDA clearance of new diagnostic tests.
  • To promote research that may be infeasible with traditional trial structures.

Main Methods:

  • MASTERMIND employs a single-protocol, multi-test approach for evaluating diagnostic assays.
  • Utilizes a single subject's sample(s) to assess multiple diagnostic tests concurrently.
  • Establishes central trial organization, standardized methods, definitions, and common comparators.

Main Results:

  • Achieves efficiencies in specimen collection and characterization.
  • Enables simultaneous evaluation of multiple diagnostic tests.
  • Facilitates robust data generation for regulatory submission.

Conclusions:

  • MASTERMIND offers an innovative and efficient strategy for advancing infectious disease diagnostics.
  • This approach supports the development and clearance of crucial new antimicrobial resistance diagnostics.
  • The protocol promotes streamlined research and development in a critical healthcare area.