运用Hoffmann和refineR算法建立血清免疫球蛋白和补体参考区间及其可行性评估  

Establishment of reference intervals of serum immunoglobulin and complement by Hoffmann and refineR algorithms and evaluation of their feasibility

作　　者：穆丹妮 马超超 马逸辰 高雨濛 程歆琦[1] Mu Danni;Ma Chaochao;Ma Yichen;Gao Yumeng;Cheng Xinqi(Department of Laboratory Medicine,Peking Union Medical College Hospital,Peking Union Medical College&Chinese Academy of Medical Science,Beijing 100730,China)

机构地区：[1]中国医学科学院北京协和医学院,北京协和医院检验科,北京100730

出　　处：《中华检验医学杂志》2025年第2期241-248,共8页Chinese Journal of Laboratory Medicine

基　　金：国家自然科学基金(72274218);国家重点研发计划(2022YFC3602302)。

摘　　要：目的采用Hoffmann和refineR两种间接法计算免疫球蛋白G(IgG)、IgA、IgM、补体3(C3)和C4的成年人参考区间,并将其与中华人民共和国卫生行业标准WS/T 645(以下简称行标)报告的参考区间进行比较,探索间接法的临床应用价值。方法横断面研究。收集2013年1月至2023年12月北京协和医院体检人群的IgG、IgA、IgM、C3和C4检测结果数据。采用Box-Cox将数据转化成正态分布,Tukey法剔除异常值。采用Mann-Whitney检验和Kruskal-Wallis检验分别比较性别和年龄的组间差异。采用分位数回归分析年龄和性别对各个指标的影响。采用Hoffmann法和refineR法分别计算5个项目的参考区间。结果IgG、IgA、IgM、C3和C4分别有82251、82483、49236、20027和19942条检测结果被纳入。性别与IgG、IgA、IgM、C3和C4水平相关,年龄与IgA、IgM、C3和C4水平相关。根据Hoffmann和refineR法,IgG总参考区间分别为7.58~16.85 g/L和7.54~16.88 g/L;IgA总参考区间分别为0.97~4.26 g/L和0.97~4.34 g/L;IgM女性参考区间分别为0.44~2.57 g/L和0.44~2.62 g/L,男性参考区间为0.33~1.91 g/L和0.31~1.87 g/L;C3总参考区间分别为0.73~1.43 g/L和0.73~1.44 g/L;C4总参考区间均为0.11~0.32 g/L。根据偏倚比进一步计算性别、年龄特异的参考区间。Hoffmann法与refineR法计算的参考区间一致性较好。间接法计算的IgA和C3参考区间上下限、IgG参考区间下限、IgM和C3参考区间上限与行标报告的参考区间具有良好的可比性。结论采用Hoffmann和refineR法建立了本医院人群IgG、IgA、IgM、C3和C4的总参考区间及性别和/或年龄特异参考区间,两种间接法建立的参考区间具有可比性。间接法参考区间与行标中采用直接抽样法建立的参考区间也具有较好的可比性。Objective To calculate the reference intervals of immune globulinG(IgG),IgA,IgM,complement 3(C3)and C4 for adults using Hoffmann and refineR methods,and to compare them with the reference interval reported by WS/T 645 of the People′s Republic of China,exploring the clinical application value of the indirect methods.MethodsCross-sectional study.The physical examination data were collected at Peking Union Medical College Hospital from 2013 to 2023.Box-Cox was used to normalize the data distribution,and the Tukey method was used to remove outliers.Mann-Whitney test and Kruskal-Wallis test were used to compare the differences between gender and age,respectively.Quantile regression analysis was used to examine the effects of age and gender.Hoffmann and refineR methods were employed to calculate RIs of the five parameters.ResultsThere were 82251,82483,49236,20027 and 19942 test results for IgG,IgA,IgM,C3 and C4,respectively.Gender was significantly correlated with IgG,IgA,IgM,C3,and C4 levels,and age was significantly correlated with IgA,IgM,C3,and C4 levels.Reference intervals were calculated using both Hoffmann and refineR methods,yielding comparable results:IgG(7.58-16.85 g/L;7.54-16.88 g/L),IgA(0.97-4.26 g/L;0.97-4.34 g/L),C3(0.73-1.43 g/L;0.73-1.44 g/L),and C4(0.11-0.32 g/L).Gender-specific intervals were established for IgM:women(0.44-2.57 g/L;0.44-2.62 g/L)and men(0.33-1.91 g/L;0.31-1.87 g/L).Gender and/or age-specific reference intervals were further calculated according to the bias ratio values.The reference intervals calculated by Hoffmann and refineR are in good agreement.The upper and lower limits of reference intervals for IgA and C3,the lower limits of IgG,the upper limits of IgM and C3 calculated by the indirect methods have good comparability with those reported by standards.ConclusionsThe total and gender/age-specific reference intervals of IgG,IgA,IgM,C3 and C4 in our hospital population were established by Hoffmann and refineR methods,and the reference intervals established by the two indirect meth

关 键 词：参考值 间接法 直接抽样法 免疫球蛋白 补体 

分 类 号：R446.6[医药卫生—诊断学]