Department of Clinical Laboratory, Mianyang Central Hospital, School of Medicine, University of Electronic Science and Technology of China, Mianyang, P.R. China.
Clin Chem Lab Med. 2022 Aug 18;60(10):1648-1660. doi: 10.1515/cclm-2021-0928. Print 2022 Sep 27.
The European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) have established a program of work to make available, and to enable delivery of well characterized data describing the biological variation (BV) of clinically important measurands. Guided by the EFLM work the study presented here delivers BV estimates obtained from Chinese subjects for 32 measurands in serum.
Samples were drawn from 48 healthy volunteers (26 males, 22 females; age range, 21-45 years) for 5 consecutive weeks at Chinese laboratory. Sera were stored at -80 °C before triplicate analysis of all samples on a Cobas 8000 modular analyzer series. Outlier and homogeneity analyses were performed, followed by CV-ANOVA, to determine BV estimates with confidence intervals.
The within-subject biological variation (CV) estimates for 30 of the 32 measurands studied, were lower than listed on the EFLM database; the exceptions were alanine aminotransferase (ALT), lipoprotein (a) (LP(a)). Most of the between-subject biological variation (CV) estimates were lower than the EFLM database entries.
This study delivers BV data for a Chinese population to supplement the EFLM BV database. Population differences may have an impact on applications of BV Data.
欧洲临床化学和实验室医学联合会（EFLM）已经制定了一项工作计划，提供并能够提供描述临床重要测量物生物学变异（BV）的特征良好的数据。在 EFLM 工作的指导下，本研究提供了来自中国受试者的 32 个血清测量物的 BV 估计值。
从中国实验室的 48 名健康志愿者（26 名男性，22 名女性；年龄范围，21-45 岁）中连续 5 周抽取样本。在 Cobas 8000 模块化分析仪系列上对所有样本进行三次重复分析之前，将血清储存在-80°C。进行离群值和同质性分析，然后进行 CV-ANOVA，以确定具有置信区间的 BV 估计值。
在所研究的 32 个测量物中的 30 个测量物的个体内生物学变异（CV）估计值低于 EFLM 数据库中的值；例外是丙氨酸氨基转移酶（ALT）和脂蛋白（a）（LP(a)）。大多数个体间生物学变异（CV）估计值低于 EFLM 数据库中的值。
本研究提供了中国人群的 BV 数据，以补充 EFLM BV 数据库。人群差异可能对 BV 数据的应用产生影响。
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