Coskun Abdurrahman
Department of Medical Biochemistry, School of Medicine, Acibadem Mehmet Ali Aydinlar University, Istanbul, Turkey.
Ann Lab Med. 2025 May 1;45(3):259-271. doi: 10.3343/alm.2024.0569. Epub 2025 Mar 21.
Measurement results of biological samples are not perfect and vary because of numerous factors related to the biological samples themselves and the measurement procedures used to analyze them. The imprecision in patients' laboratory data arising from the measurement procedure, known as analytical variation, depends on the conditions under which the data are collected. Additionally, the sample type and sampling time significantly affect patients' laboratory results, particularly in serial measurements using samples collected at different time points. For accurate interpretation of patients' laboratory data, imprecision-both its analytical and biological components-should be properly evaluated and incorporated into data management. With advancements in measurement technologies, analytical imprecision can be minimized to an insignificant level compared to biological imprecision, which is inherent to all biomolecules because of the dynamic nature of metabolism. This review addresses: (i) the theoretical background of variation, (ii) the statistical and metrological evaluation of measurement variation, (iii) the assessment of variation under different conditions in medical laboratories, (iv) the impact of measurement variation on clinical decisions, (v) the influence of biases on measurement variation, and (vi) the variability of analytes in human metabolism. Collectively, both analytical and biological imprecision are inseparable aspects of all measurements in biological samples, with biological imprecision serving as the foundation of personalized laboratory medicine.
生物样本的测量结果并不完美，且会因与生物样本本身以及用于分析它们的测量程序相关的众多因素而有所不同。测量程序导致的患者实验室数据不精确性，即所谓的分析变异，取决于数据收集的条件。此外，样本类型和采样时间会显著影响患者的实验室结果，尤其是在使用不同时间点采集的样本进行连续测量时。为了准确解读患者的实验室数据，应正确评估不精确性（包括其分析和生物成分）并将其纳入数据管理。随着测量技术的进步，与生物不精确性相比，分析不精确性可被降至微不足道的水平，生物不精确性因新陈代谢的动态性质而存在于所有生物分子中。本综述探讨了：（i）变异的理论背景，（ii）测量变异的统计和计量评估，（iii）医学实验室不同条件下变异的评估，（iv）测量变异对临床决策的影响，（v）偏差对测量变异的影响，以及（vi）人体新陈代谢中分析物的变异性。总体而言，分析不精确性和生物不精确性都是生物样本所有测量中不可分割的方面，生物不精确性是个性化检验医学的基础。
