{"title":"Nationwide external quality assessment of serum glycated albumin measurement in China during 2024-2025: current situation, challenges and prospects.","authors":"Hao Zheng, Weiyan Zhou, Jie Zeng, Chao Zhang, Haijian Zhao, Jiangtao Zhang, Jing Wang, Chuanbao Zhang, Tianjiao Zhang","doi":"10.1016/j.cca.2025.120673","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Glycated albumin (GA) serves an important alternative biomarker of glycemia, playing a key role in diabetes diagnosis. Given that the harmonization status of GA assays in China remains unclear, implementing external quality assessment (EQA) program is essential to evaluate their analytical performance. This will provide reliable information to support patient diagnosis and treatment.</p><p><strong>Methods: </strong>The National Center of Clinical Laboratories (NCCL, Beijing, China) organized a biannual EQA scheme for GA. EQA samples were distributed to the participants, who were required to measure five samples per cycle and submit their results along with detailed information on reagents, methodologies, and instruments used. Following each cycle, NCCL edited comprehensive reports summarizing individual laboratory performance and scores, including an overview of all participants' results.</p><p><strong>Results: </strong>In 2024 and 2025, 93.3 % and 95.7 % of participants achieved satisfactory annual performance, respectively. GA measurements demonstrated high precision within manufacturers, with median intra-manufacturer robust coefficient of variation (CV) below 3.1 %. However, notable disparities emerged across manufacturers: the median inter-manufacturer robust CV was 6.5 %, the median relative deviation from target values reached up to 9.3 %, and maximum deviation was as high as 40 %. Analysis based on laboratory performance showed a steady improvement trend from 2024 to 2025.</p><p><strong>Conclusions: </strong>The nationwide GA EQA program scheme has substantially improved analytical performance and cultivated a robust quality assurance culture across participating laboratories. Persistent challenges to further elevating detection quality through EQA include sample commutability, procedure for target value assignment, and replicate samples. Moving forward, fostering collaborative engagement among all stakeholders are essential to overcome these limitations and establish a harmonized framework for GA detection.</p>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":" ","pages":"120673"},"PeriodicalIF":2.9000,"publicationDate":"2025-10-17","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinica Chimica Acta","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.1016/j.cca.2025.120673","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}
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Abstract
Background: Glycated albumin (GA) serves an important alternative biomarker of glycemia, playing a key role in diabetes diagnosis. Given that the harmonization status of GA assays in China remains unclear, implementing external quality assessment (EQA) program is essential to evaluate their analytical performance. This will provide reliable information to support patient diagnosis and treatment.
Methods: The National Center of Clinical Laboratories (NCCL, Beijing, China) organized a biannual EQA scheme for GA. EQA samples were distributed to the participants, who were required to measure five samples per cycle and submit their results along with detailed information on reagents, methodologies, and instruments used. Following each cycle, NCCL edited comprehensive reports summarizing individual laboratory performance and scores, including an overview of all participants' results.
Results: In 2024 and 2025, 93.3 % and 95.7 % of participants achieved satisfactory annual performance, respectively. GA measurements demonstrated high precision within manufacturers, with median intra-manufacturer robust coefficient of variation (CV) below 3.1 %. However, notable disparities emerged across manufacturers: the median inter-manufacturer robust CV was 6.5 %, the median relative deviation from target values reached up to 9.3 %, and maximum deviation was as high as 40 %. Analysis based on laboratory performance showed a steady improvement trend from 2024 to 2025.
Conclusions: The nationwide GA EQA program scheme has substantially improved analytical performance and cultivated a robust quality assurance culture across participating laboratories. Persistent challenges to further elevating detection quality through EQA include sample commutability, procedure for target value assignment, and replicate samples. Moving forward, fostering collaborative engagement among all stakeholders are essential to overcome these limitations and establish a harmonized framework for GA detection.
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.
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