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

  • Dandan Sun , Zheng Cao , Mingyuan Jiao , Xiuzhi Guo , Ran Gao , Chaochao Ma , Ying Zhu , Lian Hou , Ying Meng , Meng Wang , Songlin Yu EMAIL logo , Yicong Yin EMAIL logo and Ling Qiu EMAIL logo
Published/Copyright: September 10, 2025

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.


Corresponding authors: Ling Qiu, Department of Laboratory Medicine, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Shuaifu Yuan No. 1, Dongcheng District, Beijing, 100730, China; and State Key Laboratory of Complex Severe and Rare Diseases, Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College, Beijing, 100730, China, E-mail: ; Yicong Yin and Songlin Yu, Department of Laboratory Medicine, Peking Union Medical College Hospital, Peking Union Medical College and Chinese Academy of Medical Science, Shuaifu Yuan No. 1, Dongcheng District, Beijing, 100730, China, E-mail: (Y. Yin), (S. Yu)
Dandan Sun, Zheng Cao and Mingyuan Jiao contributed equally to this work.
  1. Research ethics: This study was reviewed and approved by the local Ethics Committee (ID: HS2912, Date: 2021.04.27).

  2. Informed consent: Not applicable.

  3. Author contributions: All authors have accepted responsibility for the entire content of this manuscript and approved its submission. SDD, CZ, JMY: conceptualization, investigation, methodology, data curation and analysis, writing – review and editing. These authors have equal contribution to this work. GXZ, GR, HLA: methodology support, technical assistance. MCC: statistical analysis, visualization. ZY: revised it critically. MY, WM: performed experiments, resources and data collection. QL, YYC, YSL: methodology design, data interpretation, writing – review and editing, supervision, manuscript finalization, correspondence.

  4. Use of Large Language Models, AI and Machine Learning Tools: None declared.

  5. Conflict of interest: The authors state no conflict of interest.

  6. Research funding: None declared.

  7. Data availability: The datasets generated and/or analyzed during the current study are available from the corresponding author on reasonable request.

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Supplementary Material

This article contains supplementary material (https://doi.org/10.1515/cclm-2025-0530).


Received: 2025-05-02
Accepted: 2025-08-26
Published Online: 2025-09-10
Published in Print: 2026-01-27

© 2025 Walter de Gruyter GmbH, Berlin/Boston

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