Department of Clinical Biochemistry, Harrogate Foundation Trust, Harrogate, UK.
Department of Clinical Biochemistry, The Newcastle upon Tyne Hospitals NHS Foundation Trust, Newcastle upon Tyne, UK.
Ann Clin Biochem. 2020 Sep;57(5):373-381. doi: 10.1177/0004563220944204. Epub 2020 Jul 27.
Harmonization of reference intervals for analytes that have a sound calibration and metrological traceability is a widely recommended practice. The UK Pathology Harmony has recently harmonized reference intervals for calcium and albumin. In this study, we have determined the reference intervals for calcium and albumin on the UK's most commonly used analytical platforms.
A prospective reference population of healthy individuals was recruited according to the IFCC CRIDL criteria. A second indirect population was collected from 14 primary care setting and measured in laboratories using various analytical platforms and methods (Roche, Abbott, Beckman and Siemens analytical platforms).
In total, 299 subjects were recruited; the central 95th centile values for calcium for three out of four analytical platforms were in a close agreement with UK Pathology Harmony reference intervals of 2.2-2.6 mmol/L. Reference intervals of BCG methods from both cohorts and irrespective of analytical platforms were higher for both lower and upper reference limits than those for BCP. In comparison, the indirect study showed an age-related variation. The younger population reference intervals varied by up to 5.7% at the lower reference limit and up to 12% at the upper reference limit compared with Pathology Harmony reference intervals, and the older population showed a variation of up to 14% at both limits.
While calcium reference intervals can be a subject for harmonization, albumin reference intervals studied showed large variation which is unsupportive of embracing a common reference interval for albumin.
对具有良好校准和计量可追溯性的分析物参考区间进行协调一致是一项广泛推荐的做法。英国病理学会最近已经对钙和白蛋白的参考区间进行了协调一致。在这项研究中,我们确定了英国最常用的分析平台上钙和白蛋白的参考区间。
根据 IFCC CRIDL 标准,前瞻性地招募了健康个体的参考人群。第二个间接人群来自 14 个初级保健环境,并在使用各种分析平台和方法(罗氏、雅培、贝克曼和西门子分析平台)的实验室中进行测量。
共招募了 299 名受试者;四个分析平台中有三个的中心 95%百分位数值与英国病理学会的参考区间 2.2-2.6mmol/L 非常接近。来自两个队列的 BCG 方法的参考区间,无论分析平台如何,其上下限都高于 BCP。相比之下,间接研究显示出与年龄相关的变化。与病理学会的参考区间相比,年轻人群的参考区间在较低的参考限处变化高达 5.7%,在较高的参考限处变化高达 12%,而老年人群在两个限处的变化高达 14%。
虽然钙的参考区间可以进行协调一致,但研究中白蛋白的参考区间显示出很大的差异,不支持采用白蛋白的通用参考区间。