Analytical quality goals-a review

Vet Clin Pathol. 2018 Dec;47(4):527-538. doi: 10.1111/vcp.12649. Epub 2018 Aug 28.

Abstract

Analytical quality goals indicate how laboratory tests must perform to be clinically useful for their intended purpose. These goals have historically focused on analytical error assessment for quantitative methods and vary with measurand concentration or activity, and species. Although formalized quality goal models have been developed in human medicine, quality goals in veterinary medicine, to date, have not been formalized; use of human regulatory-based goals, consensus-based goals, or biologic variation-based goals have been reported most often. This review provides an overview of how quality goals are derived, how these may be used, and highlights challenges. Pending formal recommendations, individual veterinary laboratories should select quality goals that make the most sense clinically, logistically, and financially based on their individual needs and the needs of the clients that they serve.

Keywords: Allowable total error; TEA; biological variation; quality control; quality requirement; quality specification.

Publication types

  • Review

MeSH terms

  • Animals
  • Chemistry, Clinical / standards
  • Clinical Laboratory Techniques / standards
  • Clinical Laboratory Techniques / veterinary*
  • Organizational Objectives
  • Quality Assurance, Health Care / methods
  • Quality Assurance, Health Care / standards
  • Quality of Health Care / standards*