Comparison of four indirect methods for establishing sex- and age-specific reference intervals for IgG: based on real world data

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2025-06-08 DOI:10.1016/j.cca.2025.120420

Wensong Liu , Zhixian Xie , Meng Wang , Zhixuan Guo , Qian Zhang , Lijuan Wang , Jiaqi Zhang , Xiaoshuang Zhu , Chuanbao Li , Shunli Zhang

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引用次数: 0

Abstract

Objective

To compare four indirect methods for establishing sex- and age-specific reference intervals (RI) for adult serum immunoglobulin G (IgG) based on real world data.

Methods

All serum IgG measurement results from 2020 to 2021 in Beijing Hospital were collated. Following data screening, four indirect methods were applied to calculate the RI of the total population, different sexes, ages and seasons (months). The results were then compared with the manufacturer’s RI and National Industry Standard in China to verify the reliability of the RI obtained in this study. The minimal allowable bias of the CV of the RI and the permissible difference (pD) elaborated by the German Society for Clinical Chemistry and Laboratory Medicine (DGKL) were used as the criterion.

Results

A total of 13,162 data points were obtained. There were significant differences between men and women within the RI calculated by four methods. With increasing age, the upper limit of RI (URL) increased and the lower limit reference (LRL )decreased. However, there was no obvious trend in different seasons. The LRL of the four methods were within the pD based on manufacturer’s RI, while the URL of the Hoffmann and RefineR methods conformed to the pD based on the National Industry Standard’s RI, and neither the RI of the National Industry Standard nor the manufacturer's were within the minimal allowable bias of the CV of the RI with our study.

Conclusions

The serum IgG RI were established by four indirect method. The significant differences were found between males and females, younger and older. Clinical laboratories should establish their own RI in order to better diagnose and treat disease.

查看原文本刊更多论文

基于真实世界数据建立IgG特异性参考区间的四种间接方法的比较。

目的：比较基于真实世界数据建立成人血清免疫球蛋白G （IgG）的性别和年龄特异性参考区间（RI）的四种间接方法。方法：整理北京医院2020 ~ 2021年全部血清IgG检测结果。在资料筛选后，采用4种间接方法计算总人口、不同性别、年龄和季节（月）的RI。然后将结果与制造商的RI和中国国家行业标准进行比较，以验证本研究中获得的RI的可靠性。RI CV的最小允许偏差和德国临床化学和检验医学学会（DGKL）制定的允许差异（pD）被用作标准。结果：共获得13162个数据点。在四种方法计算的RI内，男性和女性之间存在显著差异。随着年龄的增长，RI上限增大，下限降低。不同季节间无明显变化趋势。四种方法的下限参考限值（LRL）均在基于制造商RI的pD范围内，而Hoffmann和RefineR方法的上限参考限值（URL）均符合基于国家行业标准RI的pD，且国家行业标准和行业标准的RI均未在本研究的RI CV的最小允许偏差范围内。结论：采用四种间接方法建立血清IgG RI。男性和女性、年轻人和老年人之间存在显著差异。临床实验室应建立自己的RI，以便更好地诊断和治疗疾病。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

Clinica Chimica Acta 医学-医学实验技术

CiteScore

10.10

自引率

2.00%

发文量

1268

审稿时长

23 days

期刊介绍： The Official Journal of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) Clinica Chimica Acta is a high-quality journal which publishes original Research Communications in the field of clinical chemistry and laboratory medicine, defined as the diagnostic application of chemistry, biochemistry, immunochemistry, biochemical aspects of hematology, toxicology, and molecular biology to the study of human disease in body fluids and cells. The objective of the journal is to publish novel information leading to a better understanding of biological mechanisms of human diseases, their prevention, diagnosis, and patient management. Reports of an applied clinical character are also welcome. Papers concerned with normal metabolic processes or with constituents of normal cells or body fluids, such as reports of experimental or clinical studies in animals, are only considered when they are clearly and directly relevant to human disease. Evaluation of commercial products have a low priority for publication, unless they are novel or represent a technological breakthrough. Studies dealing with effects of drugs and natural products and studies dealing with the redox status in various diseases are not within the journal''s scope. Development and evaluation of novel analytical methodologies where applicable to diagnostic clinical chemistry and laboratory medicine, including point-of-care testing, and topics on laboratory management and informatics will also be considered. Studies focused on emerging diagnostic technologies and (big) data analysis procedures including digitalization, mobile Health, and artificial Intelligence applied to Laboratory Medicine are also of interest.