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Analytical quality goals-a review.

Bente Flatland1, Melinda S Camus2, Randolph M Baral3

  • 1Department of Biomedical & Diagnostic Sciences, College of Veterinary Medicine, University of Tennessee, Knoxville, Tennessee.

Veterinary Clinical Pathology
|August 29, 2018
PubMed
Summary
This summary is machine-generated.

Analytical quality goals ensure laboratory tests are clinically useful. Veterinary medicine currently lacks formalized goals, often relying on human or consensus-based standards, necessitating careful selection by individual labs.

Keywords:
Allowable total errorTEAbiological variationquality controlquality requirementquality specification

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Area of Science:

  • Veterinary Laboratory Medicine
  • Clinical Pathology
  • Analytical Quality Management

Background:

  • Analytical quality goals define the performance needed for clinically useful laboratory tests.
  • Historically, focus has been on analytical error for quantitative methods, varying by concentration and species.
  • Formalized quality goal models exist in human medicine, but not yet in veterinary medicine.

Purpose of the Study:

  • To review the derivation and application of analytical quality goals.
  • To highlight challenges in establishing quality goals for veterinary diagnostics.
  • To provide guidance for veterinary laboratories in selecting appropriate quality goals.

Main Methods:

  • Literature review of analytical quality goal models.
  • Analysis of current practices in veterinary laboratory quality assessment.
  • Discussion of challenges and considerations for goal selection.

Main Results:

  • Veterinary laboratories commonly use human regulatory-based, consensus-based, or biologic variation-based goals.
  • There is a lack of formalized, veterinary-specific quality goal frameworks.
  • Selection of goals requires consideration of clinical utility, logistics, and financial feasibility.

Conclusions:

  • Formalization of quality goals in veterinary medicine is pending.
  • Individual veterinary laboratories must currently select goals based on specific needs and client requirements.
  • Prudent selection of quality goals is crucial for ensuring reliable veterinary diagnostics.