Department of Laboratory Medicine, The First Hospital of China Medical University, National Clinical Research Center for Laboratory Medicine, Shenyang, Liaoning, P.R. China.
Clin Chem Lab Med. 2021 Nov 15;60(4):606-617. doi: 10.1515/cclm-2021-0479. Print 2022 Mar 28.
A large number of people undergo annual health checkup but accurate laboratory criterion for evaluating their health status is limited. The present study determined annual biological variation (BV) and derived parameters of common laboratory analytes in order to accurately evaluate the test results of the annual healthcare population.
A total of 43 healthy individuals who had regular healthcare once a year for six consecutive years, were enrolled using physical, electrocardiogram, ultrasonography and laboratory. The annual BV data and derived parameters, such as reference change value (RCV) and index of individuality (II) were calculated and compared with weekly data. We used annual BV and homeostatic set point to calculate personalized reference intervals (RI) which were compared with population-based reference intervals (RI).
We have established the annual within-subject BV (CV), RCV, II, RI of 24 commonly used clinical chemistry and hematology analytes for healthy individuals. Among the 18 comparable measurands, CV estimates of annual data for 11 measurands were significantly higher than the weekly data. Approximately 50% measurands of II were <0.6, the utility of their RI were limited. The distribution range of RI for most measurands only copied small part of RI with reference range index for 8 measurands <0.5.
Compared with weekly BV, for annual healthcare individuals, annual BV and related parameters can provide more accurate evaluation of laboratory results. RI based on long-term BV data is very valuable for "personalized" diagnosis on annual health assessments.
许多人每年都会进行健康检查，但评估其健康状况的准确实验室标准有限。本研究旨在确定常见实验室分析物的年度生物学变异（BV）和相关参数，以便准确评估年度医疗保健人群的检测结果。
共纳入 43 名健康个体，他们每年定期进行一次医疗保健，连续 6 年进行体检、心电图、超声和实验室检查。计算并比较了年度 BV 数据及其衍生参数，如参考变化值（RCV）和个体指数（II），并与每周数据进行比较。我们使用年度 BV 和体内平衡点来计算个性化参考区间（RI），并与基于人群的参考区间（RI）进行比较。
我们为健康个体建立了 24 种常用临床化学和血液学分析物的年度个体内 BV（CV）、RCV、II 和 RI。在 18 个可比较的测定物中，11 个测定物的年度数据 CV 估计值明显高于每周数据。大约 50%的 II 值<0.6，其 RI 的实用性有限。大多数测定物的 RI 分布范围仅复制了 RI 的一小部分，8 个测定物的 RI 参考范围指数<0.5。
与每周 BV 相比，对于年度医疗保健个体，年度 BV 和相关参数可以更准确地评估实验室结果。基于长期 BV 数据的 RI 对于年度健康评估的“个性化”诊断非常有价值。
