CALIPER Program, Department of Pediatric Laboratory Medicine, Hospital for Sick Children, Toronto, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, Canada.
Cincinnati Children's Hospital, Cincinnati, OH, United States.
Clin Biochem. 2022 Jan;99:69-77. doi: 10.1016/j.clinbiochem.2021.10.006. Epub 2021 Oct 20.
Pediatric reference intervals are essential for test interpretation. With development of newer analytical systems, de novo reference interval establishment is of necessary importance. In the current study, pediatric reference intervals were determined for 32 analytes using Siemens Healthineers Atellica® CH assays in the CALIPER cohort of healthy children and adolescents.
Approximately 600 healthy children and adolescents were recruited with informed consent and collected serum samples were analyzed on the Siemens Healthineers Atellica® CH platform. Assays studied included enzymes, proteins, lipids, electrolytes, and additional markers Reference intervals were established according to Clinical and Laboratory Standards Institute (CLSI) guidelines.
Of the 32 parameters, 26 required age partitioning and 18 required sex partitioning. Reference value distributions included consistent increases, decreases, and dynamic variation across the age continuum. Chloride, LDL cholesterol, glucose, lipase, sodium, and triglyceride demonstrated no age or sex-specific differences.
The current study expands the clinical utility of the CALIPER database to include 32 Siemens Atellica® chemistry assays. Reference value distributions for Siemens assays mirrored those observed on other comparable assays/systems with few exceptions (e.g. lipase, direct and total bilirubin). These finding support the robustness of previously derived reference intervals in the CALIPER cohort and other global cohorts.
儿科参考区间对于检验解释至关重要。随着新分析系统的发展,重新建立参考区间变得非常重要。在本研究中,使用西门子 Atellica® CH 分析系统在 CALIPER 健康儿童和青少年队列中确定了 32 种分析物的儿科参考区间。
大约 600 名健康儿童和青少年在知情同意的情况下招募,并采集血清样本,在西门子 Atellica® CH 平台上进行分析。研究的检测项目包括酶、蛋白质、脂质、电解质和其他标志物。参考区间是根据临床和实验室标准协会(CLSI)指南建立的。
在 32 个参数中,有 26 个需要按年龄分组,18 个需要按性别分组。参考值分布包括在年龄连续体上的一致增加、减少和动态变化。氯、LDL 胆固醇、葡萄糖、脂肪酶、钠和甘油三酯没有年龄或性别特异性差异。
本研究将 CALIPER 数据库的临床应用扩展到包括 32 项西门子 Atellica® 化学分析检测。西门子检测的参考值分布与其他类似检测/系统观察到的分布相似,只有少数例外(如脂肪酶、直接和总胆红素)。这些发现支持在 CALIPER 队列和其他全球队列中以前推导的参考区间的稳健性。