Comparison of seven different enzymatic methods for serum glycated albumin in pregnant women: a multicenter study.

IF 3.7 2区 医学 Q1 MEDICAL LABORATORY TECHNOLOGY
Dandan Sun, Zheng Cao, Mingyuan Jiao, Xiuzhi Guo, Ran Gao, Chaochao Ma, Ying Zhu, Lian Hou, Ying Meng, Meng Wang, Songlin Yu, Yicong Yin, Ling Qiu
{"title":"Comparison of seven different enzymatic methods for serum glycated albumin in pregnant women: a multicenter study.","authors":"Dandan Sun, Zheng Cao, Mingyuan Jiao, Xiuzhi Guo, Ran Gao, Chaochao Ma, Ying Zhu, Lian Hou, Ying Meng, Meng Wang, Songlin Yu, Yicong Yin, Ling Qiu","doi":"10.1515/cclm-2025-0530","DOIUrl":null,"url":null,"abstract":"<p><strong>Objectives: </strong>To evaluate the consistency of seven enzymatic glycated albumin (GA) assays in pregnant women based on a multicenter study.</p><p><strong>Methods: </strong>Samples were collected from pregnant women at three different gestational stages: 4-13 weeks (n=150), 24-28 weeks (n=300, including 150 GDM subjects), and 29-40 weeks (n=300, including 150 GDM subjects), across three hospitals between July 2022 and December 2023 in China. These samples were analyzed using seven enzymatic GA methods (Lucica, Norudia, BSBE, Maccura, Meikang, Reebio, and Zybio assays). Spearman correlation analysis, Passing-Bablok regression, and Bland-Altman plots were used to evaluate the consistency between the Lucica used in our laboratory and the other selected assays. The effects of albumin concentration and gestational stage on the consistency of GA were evaluated through stratified analyses.</p><p><strong>Results: </strong>The correlation coefficients between Lucica and the other six assays for GA% measurement ranged from 0.741 to 0.906 (p<0.0001), with the mean relative biases ranging from -15.5 to +6.7 %. In trimester-stratified analysis, the highest correlation coefficient was observed in the first trimester for all assays except Maccura, and the bias increased with advancing gestational age for all assays except BSBE. In albumin-stratified analysis (30-45 g/L), the correlation increased with increasing albumin concentration for all assays, while the bias decreased except for BSBE and Maccura assays.</p><p><strong>Conclusions: </strong>Poor analytical consistency was observed in enzymatic GA assays for pregnant women, with discrepancies varying across gestational stages and albumin concentrations. Reference intervals for pregnant women should be established based on trimester-stratified and manufacturer-specific criteria.</p>","PeriodicalId":10390,"journal":{"name":"Clinical chemistry and laboratory medicine","volume":" ","pages":""},"PeriodicalIF":3.7000,"publicationDate":"2025-09-10","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinical chemistry and laboratory medicine","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1515/cclm-2025-0530","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q1","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
引用次数: 0

Abstract

Objectives: To evaluate the consistency of seven enzymatic glycated albumin (GA) assays in pregnant women based on a multicenter study.

Methods: Samples were collected from pregnant women at three different gestational stages: 4-13 weeks (n=150), 24-28 weeks (n=300, including 150 GDM subjects), and 29-40 weeks (n=300, including 150 GDM subjects), across three hospitals between July 2022 and December 2023 in China. These samples were analyzed using seven enzymatic GA methods (Lucica, Norudia, BSBE, Maccura, Meikang, Reebio, and Zybio assays). Spearman correlation analysis, Passing-Bablok regression, and Bland-Altman plots were used to evaluate the consistency between the Lucica used in our laboratory and the other selected assays. The effects of albumin concentration and gestational stage on the consistency of GA were evaluated through stratified analyses.

Results: The correlation coefficients between Lucica and the other six assays for GA% measurement ranged from 0.741 to 0.906 (p<0.0001), with the mean relative biases ranging from -15.5 to +6.7 %. In trimester-stratified analysis, the highest correlation coefficient was observed in the first trimester for all assays except Maccura, and the bias increased with advancing gestational age for all assays except BSBE. In albumin-stratified analysis (30-45 g/L), the correlation increased with increasing albumin concentration for all assays, while the bias decreased except for BSBE and Maccura assays.

Conclusions: Poor analytical consistency was observed in enzymatic GA assays for pregnant women, with discrepancies varying across gestational stages and albumin concentrations. Reference intervals for pregnant women should be established based on trimester-stratified and manufacturer-specific criteria.

孕妇血清糖化白蛋白7种不同酶法的比较:一项多中心研究。
目的:基于一项多中心研究,评价7种酶促糖化白蛋白(GA)检测在孕妇中的一致性。方法:在2022年7月至2023年12月期间,从中国三家医院的3个不同妊娠阶段的孕妇中收集样本:4-13周(n=150), 24-28周(n=300,包括150名GDM受试者)和29-40周(n=300,包括150名GDM受试者)。采用Lucica、Norudia、BSBE、Maccura、Meikang、Reebio和Zybio等7种酶促GA法对样品进行分析。使用Spearman相关分析、Passing-Bablok回归和Bland-Altman图来评估我们实验室使用的Lucica与其他选择的检测方法之间的一致性。通过分层分析评价白蛋白浓度和妊娠期对GA一致性的影响。结果:Lucica与其他6种测定GA%的方法的相关系数为0.741 ~ 0.906。结论:孕妇酶促GA测定方法的分析一致性较差,在不同妊娠期和不同白蛋白浓度下存在差异。孕妇的参考区间应根据妊娠期分层和制造商特定标准确定。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
求助全文
约1分钟内获得全文 求助全文
来源期刊
Clinical chemistry and laboratory medicine
Clinical chemistry and laboratory medicine 医学-医学实验技术
CiteScore
11.30
自引率
16.20%
发文量
306
审稿时长
3 months
期刊介绍: Clinical Chemistry and Laboratory Medicine (CCLM) publishes articles on novel teaching and training methods applicable to laboratory medicine. CCLM welcomes contributions on the progress in fundamental and applied research and cutting-edge clinical laboratory medicine. It is one of the leading journals in the field, with an impact factor over 3. CCLM is issued monthly, and it is published in print and electronically. CCLM is the official journal of the European Federation of Clinical Chemistry and Laboratory Medicine (EFLM) and publishes regularly EFLM recommendations and news. CCLM is the official journal of the National Societies from Austria (ÖGLMKC); Belgium (RBSLM); Germany (DGKL); Hungary (MLDT); Ireland (ACBI); Italy (SIBioC); Portugal (SPML); and Slovenia (SZKK); and it is affiliated to AACB (Australia) and SFBC (France). Topics: - clinical biochemistry - clinical genomics and molecular biology - clinical haematology and coagulation - clinical immunology and autoimmunity - clinical microbiology - drug monitoring and analysis - evaluation of diagnostic biomarkers - disease-oriented topics (cardiovascular disease, cancer diagnostics, diabetes) - new reagents, instrumentation and technologies - new methodologies - reference materials and methods - reference values and decision limits - quality and safety in laboratory medicine - translational laboratory medicine - clinical metrology Follow @cclm_degruyter on Twitter!
×
引用
GB/T 7714-2015
复制
MLA
复制
APA
复制
导出至
BibTeX EndNote RefMan NoteFirst NoteExpress
×
提示
您的信息不完整,为了账户安全,请先补充。
现在去补充
×
提示
您因"违规操作"
具体请查看互助需知
我知道了
×
提示
确定
请完成安全验证×
copy
已复制链接
快去分享给好友吧!
我知道了
右上角分享
点击右上角分享
0
联系我们:info@booksci.cn Book学术提供免费学术资源搜索服务,方便国内外学者检索中英文文献。致力于提供最便捷和优质的服务体验。 Copyright © 2023 布克学术 All rights reserved.
京ICP备2023020795号-1
ghs 京公网安备 11010802042870号
Book学术文献互助
Book学术文献互助群
群 号:604180095
Book学术官方微信