Flatland Bente, Camus Melinda S, Baral Randolph M
Department of Biomedical & Diagnostic Sciences, College of Veterinary Medicine, University of Tennessee, Knoxville, Tennessee.
Department of Pathology, College of Veterinary Medicine, University of Georgia, Athens, Georgia.
Vet Clin Pathol. 2018 Dec;47(4):527-538. doi: 10.1111/vcp.12649. Epub 2018 Aug 28.
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.
分析质量目标表明实验室检测必须达到怎样的性能才能在临床上对其预期用途有用。这些目标历来侧重于定量方法的分析误差评估,并且会因被测量物的浓度或活性以及种类的不同而有所变化。虽然人类医学中已经开发出了形式化的质量目标模型,但迄今为止,兽医学中的质量目标尚未形式化;最常报道的是使用基于人类监管的目标、基于共识的目标或基于生物学变异的目标。本综述概述了质量目标的推导方式、其可能的用途,并强调了挑战。在正式建议出台之前,各个兽医实验室应根据自身需求以及所服务客户的需求,选择在临床、后勤和财务方面最具意义的质量目标。