Ma Chaochao, Guan Lihua, Li Pengchang, Hou Lian, Xia Liangyu, Su Wei, Qiu Ling
Department of Laboratory Medicine, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing 100730, China; Department of Occupational and Environmental Health Sciences, School of Public Health, Peking University, Beijing 100191, China.
Department of Laboratory Medicine, Peking Union Medical College Hospital, Peking Union Medical College & Chinese Academy of Medical Science, Beijing 100730, China.
Clin Chim Acta. 2025 Feb 1;567:120114. doi: 10.1016/j.cca.2024.120114. Epub 2024 Dec 28.
Serum protein electrophoresis (SPE) is essential for diagnosing monoclonal gammopathies and a variety of other diseases. Despite its importance, there is a scarcity of SPE parameter reference intervals (RIs) derived from large datasets. This study seeks to fill this gap by establishing sex-specific RIs using Hoffmann and refineR algorithms and assessing the feasibility of these methods.
We utilized two health check-up population databases to create a reference and a validation set. The reference set included 52,293 individuals with outlier removal via the Tukey method. Variance component analysis was used to evaluate the impact of sex and age on SPE parameters. The Hoffmann and refineR algorithms were applied to establish RIs, with the bias ratio method comparing RI differences. Validation data from differing timeframes helped assess the RIs' reliability and utility. Moreover, we juxtaposed our RIs with previous studies to identify potential disparities.
Sex-specific RIs were established using the Hoffmann and refineR algorithms, with high consistency between the two algorithms, except for a slight difference in upper limits (ULs) of α1-globulin and β1-globulin. Additionally, there are sex differences in RIs for α2-globulin, β2-globulin, γ-globulin, and Albumin. In the validation analysis, all established RIs passed verification, except for RIs determined by refineR for female α1-globulin and male β2-globulin.
This research highlights the critical impact of sex on SPE RIs and the need for tailored RIs in distinct clinical environments. The utility and feasibility of the Hoffmann and refineR algorithms for creating these customized intervals are effectively demonstrated.
血清蛋白电泳（SPE）对于诊断单克隆丙种球蛋白病和多种其他疾病至关重要。尽管其很重要，但源自大型数据集的SPE参数参考区间（RI）却很匮乏。本研究旨在通过使用霍夫曼算法和refineR算法建立性别特异性RI并评估这些方法的可行性来填补这一空白。
我们利用两个健康体检人群数据库创建了一个参考集和一个验证集。参考集包括52293名个体，通过Tukey方法去除了异常值。采用方差成分分析来评估性别和年龄对SPE参数的影响。应用霍夫曼算法和refineR算法建立RI，采用偏差率方法比较RI差异。来自不同时间框架的验证数据有助于评估RI的可靠性和实用性。此外，我们将我们的RI与先前的研究进行对比以识别潜在差异。
使用霍夫曼算法和refineR算法建立了性别特异性RI，两种算法之间具有高度一致性，除了α1球蛋白和β1球蛋白的上限（UL）略有差异。此外，α2球蛋白、β2球蛋白、γ球蛋白和白蛋白的RI存在性别差异。在验证分析中，所有建立的RI均通过验证，除了refineR确定的女性α1球蛋白和男性β2球蛋白的RI。
本研究强调了性别对SPE RI的关键影响以及在不同临床环境中需要定制RI。有效证明了霍夫曼算法和refineR算法用于创建这些定制区间的实用性和可行性。
