Badrick Tony
Royal College of Pathologists of Australasia Quality Assurance Programs, St Leonards Sydney, NSW, 2065, Australia.
Pract Lab Med. 2021 Jan 4;23:e00199. doi: 10.1016/j.plabm.2020.e00199. eCollection 2021 Jan.
This Review will describe the increasing importance of the concepts of biological variation to clinical chemists. The idea of comparison to 'reference' is fundamental in measurement. For the biological measurands, that reference is the relevant patient population, a clinical decision point based on a trial or an individual patient's previous results. The idea of using biological variation to set quality goals was then realised for setting Quality Control (QC) and External Quality Assurance (EQA) limits. The current phase of BV integration into practice is using Patient-Based Real-Time Quality Control (PBRTQC) and Patient Based Quality Assurance (PBQA) to detect a change in assay performance. The challenge of personalised medicine is to determine an individual reference interval. The Athletes Biological Passport may provide the solution.
本综述将阐述生物变异概念对临床化学家日益增长的重要性。与“参考值”进行比较的理念在测量中至关重要。对于生物测量值而言，该参考值是相关患者群体、基于试验的临床决策点或个体患者的既往结果。随后，人们意识到利用生物变异来设定质量目标，以确定质量控制（QC）和外部质量保证（EQA）的限值。目前将生物变异整合到实践中的阶段是使用基于患者的实时质量控制（PBRTQC）和基于患者的质量保证（PBQA）来检测分析性能的变化。个性化医疗面临的挑战是确定个体参考区间。运动员生物护照或许能提供解决方案。
