Clinical Biochemistry Division, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
Clinical Biochemistry Division, Department of Pediatric Laboratory Medicine, The Hospital for Sick Children, University of Toronto, Toronto, ON, Canada.
Clin Biochem. 2014 Feb;47(3):166-72. doi: 10.1016/j.clinbiochem.2013.11.008. Epub 2013 Dec 4.
To compare pediatric reference intervals calculated using hospital-based patient data with those calculated using samples collected from healthy children in the community as part of the CALIPER study.
Hospital-based data for 13 analytes (calcium, phosphate, iron, ALP, cholesterol, triglycerides, creatinine, direct bilirubin, total bilirubin, ALT, AST, albumin and magnesium), measured on the Vitros 5600, collected between 2007 and 2011 were obtained. The data for each analyte were partitioned by age and gender as previously defined by the CALIPER study. Outliers in each partition were removed using the Tukey method. The cumulative distribution function (cdf) was then determined for each analyte value following which, the inverse cdf values of a standard Gaussian distribution were calculated. The analyte values were plotted against the inverse cdf of the standard Gaussian distribution. Piece-wise regression determined the linear portion of the resulting graph using the statistical software R. Linear regression determined an equation for the linear portion in each partition and reference intervals were calculated by extrapolating to identify the 2.5th and 97.5th centiles in each partition based on the inverse cdf values (which would correspond to the values -1.96 and 1.96 of the Gaussian distribution). Using the 90% confidence intervals for the reference intervals defined by CALIPER and the Reference Change Value (RCV) as the criteria, these calculated reference intervals were compared to those reported previously by CALIPER. Reference samples were also measured on the Vitros 5600 analyzer in an attempt to validate the calculated reference intervals.
In general, the reference intervals calculated from hospital-based data were generally wider than those calculated by CALIPER. None of the reference intervals calculated using the Hoffmann approach fell completely within the 90% confidence intervals calculated by CALIPER.
These results suggest that calculating pediatric reference intervals from hospital-based data may be useful, as a guide, in some cases but will likely not replace the need to establish reference intervals in healthy pediatric populations.
比较使用医院患者数据计算的儿科参考区间与使用社区健康儿童样本（作为 CALIPER 研究的一部分）计算的参考区间。
获取了 2007 年至 2011 年期间在 Vitros 5600 上测量的 13 种分析物（钙、磷、铁、碱性磷酸酶、胆固醇、甘油三酯、肌酐、直接胆红素、总胆红素、丙氨酸氨基转移酶、天冬氨酸氨基转移酶、白蛋白和镁）的基于医院的数据分析。根据 CALIPER 研究先前的定义，按年龄和性别对每种分析物的数据进行分区。使用 Tukey 方法去除每个分区中的异常值。然后，为每个分析物值确定累积分布函数 (cdf)，之后计算标准正态分布的逆 cdf 值。将分析物值绘制为标准正态分布逆 cdf 的函数。分段回归使用统计软件 R 确定图形的线性部分。线性回归确定了每个分区中线性部分的方程，并通过外推来计算参考区间，以根据逆 cdf 值识别每个分区中的 2.5%和 97.5%分位数（这将对应于正态分布的-1.96 和 1.96 值）。使用 CALIPER 定义的参考区间的 90%置信区间和参考变化值 (RCV) 作为标准，将这些计算的参考区间与 CALIPER 先前报告的参考区间进行比较。还在 Vitros 5600 分析仪上测量参考样本，试图验证计算出的参考区间。
一般来说，基于医院数据计算的参考区间通常比 CALIPER 计算的参考区间宽。使用 Hoffmann 方法计算的参考区间没有一个完全在 CALIPER 计算的 90%置信区间内。
这些结果表明，从医院数据计算儿科参考区间在某些情况下可能是有用的，作为一种指南，但不太可能取代在健康儿科人群中建立参考区间的需要。
