Department of Chemical pathology, SydPath, St Vincent's Hospital, Darlinghurst, NSW, Australia.
Facult of Medicine, University of NSW, Kensington, Australia.
Clin Chem Lab Med. 2024 Apr 16;62(8):1512-1519. doi: 10.1515/cclm-2024-0102. Print 2024 Jul 26.
Analytical performance specifications (APS) are used for the quantitative assessment of assay analytical performance, with the aim of providing information appropriate for clinical care of patients. One of the major locations where APS are used is in the routine clinical laboratory. These may be used to assess and monitor assays in a range of settings including method selection, method verification or validation, external quality assurance, internal quality control and assessment of measurement uncertainty. The aspects of assays that may be assessed include imprecision, bias, selectivity, sample type, analyte stability and interferences. This paper reviews the practical use of APS in a routine clinical laboratory, using the laboratory I supervise as an example.
分析性能规格 (APS) 用于定量评估分析性能，旨在为患者的临床护理提供适当的信息。APS 的主要使用地点之一是常规临床实验室。这些可用于评估和监测包括方法选择、方法验证或确认、外部质量保证、内部质量控制和测量不确定度评估在内的各种环境中的检测。可能评估的检测方面包括不精密度、偏差、选择性、样本类型、分析物稳定性和干扰。本文以我所在的实验室为例，介绍了 APS 在常规临床实验室中的实际应用。
