生物学变异在临床生物化学中的应用

Application of biological variation in clinical biochemistry

生物学变异(BV)分为可预测的周期变异、个体内变异(CVI)和个体间变异(CVG)。本文通过介绍欧洲临床化学和实验医学联合会(EFLM)最新的BV研究数据,得到分析性能(APS)的不同质量标准、检验项目参考变化值(RCV)及其有用性评估表。除尿素和低密度脂蛋白外,所有被测量的CVI估计值均低于在线数据库报告的数据。因临床需求提高、检测技术革新及各项标准的不断完善,过去的检测数据无法满足临床需求。EFLM最新的BV数据均采用标准化分析,且研究方法更现代化,与当前临床实践关系更为密切,故对患者及临床医师更具有适用性。

Biological variation(BV)can be divided into predictable periodic variation,within-subject biological coeffitient of variation(CVI)and between-subject biological coeffitient of variation(CVG).This article introduced the latest BV data of European Federation of Clinical Chemistry and Laboratory Medicine(EFLM),and the different quality standards of analytical performance specifications(APS),reference variation value(RCV)of inspection items and their usefulness evaluation table were obtained.Except for urea and low density lipoprotein,all CVI estimates measured were lower than those reported in online database.Due to the improvement of clinical needs,innovation of detection technology and continuous improvement of various standards,the past test data could not meet the clinical needs.The latest BV data of EFLM adopted standardized analysis,and the research methods were more modern and closely related to the current clinical practice,so it was more applicable to patients and clinicians.