Comparability of the LDH measurement and analysis based on external quality assessment

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2025-01-25 DOI:10.1016/j.cca.2025.120157

Guanfei Zhao, Ning Wang, Rui Zhang, Shunli Zhang

{"title":"Comparability of the LDH measurement and analysis based on external quality assessment","authors":"Guanfei Zhao, Ning Wang, Rui Zhang, Shunli Zhang","doi":"10.1016/j.cca.2025.120157","DOIUrl":null,"url":null,"abstract":"<div><h3>Background</h3><div>Lactate dehydrogenase (LDH) is a critical enzyme widely used in clinical diagnostics. However, variations in measurement systems can lead to inconsistent results, potentially impacting clinical decision-making. This study aimed to evaluate the comparability of lactate dehydrogenase measurements by comparing routine methods with the IFCC reference method, and to analyze the standardization status of LDH testing through external quality assessment (EQA).</div></div><div><h3>Methods</h3><div>We analyzed 40 individual serum samples using four routine LD measurement systems: Siemens ADVIA 2400, Hitachi 7600/BioSino, Beckman AU5800, and Roche Cobas C501, alongside the IFCC reference method. The analytical quality specification (±6.4 %) was based on biological variation. Our study also included a comprehensive external quality assessment (EQA) program conducted by the Beijing Center for Clinical Laboratory (BCCL) over three years (2020, 2021, and 2023) to evaluate the consistency and reliability of LD measurements across different reagents. The acceptance limit is based on the requirement of desirable biological variability (±11.4 %).</div></div><div><h3>Results</h3><div>All four measurement systems showed strong correlations with the IFCC reference method (r ≥ 0.98). Relative average deviations ranged from −5.23 % to 3.71 %, within the acceptable biological variation limit. External quality assessment revealed high pass rates (94.9 %-98.7 %) across reagent groups, with significant improvements observed in some reagent groups from 2020 to 2023..</div></div><div><h3>Conclusions</h3><div>While the four LD measurement systems demonstrated good correlation with the IFCC reference method, some systems require further standardization. The study provides valuable insights into LD measurement accuracy and supports ongoing efforts to enhance laboratory testing comparability.</div></div>","PeriodicalId":10205,"journal":{"name":"Clinica Chimica Acta","volume":"569 ","pages":"Article 120157"},"PeriodicalIF":3.2000,"publicationDate":"2025-01-25","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Clinica Chimica Acta","FirstCategoryId":"3","ListUrlMain":"https://www.sciencedirect.com/science/article/pii/S0009898125000361","RegionNum":3,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q2","JCRName":"MEDICAL LABORATORY TECHNOLOGY","Score":null,"Total":0}

引用次数: 0

Abstract

Background

Lactate dehydrogenase (LDH) is a critical enzyme widely used in clinical diagnostics. However, variations in measurement systems can lead to inconsistent results, potentially impacting clinical decision-making. This study aimed to evaluate the comparability of lactate dehydrogenase measurements by comparing routine methods with the IFCC reference method, and to analyze the standardization status of LDH testing through external quality assessment (EQA).

Methods

We analyzed 40 individual serum samples using four routine LD measurement systems: Siemens ADVIA 2400, Hitachi 7600/BioSino, Beckman AU5800, and Roche Cobas C501, alongside the IFCC reference method. The analytical quality specification (±6.4 %) was based on biological variation. Our study also included a comprehensive external quality assessment (EQA) program conducted by the Beijing Center for Clinical Laboratory (BCCL) over three years (2020, 2021, and 2023) to evaluate the consistency and reliability of LD measurements across different reagents. The acceptance limit is based on the requirement of desirable biological variability (±11.4 %).

Results

All four measurement systems showed strong correlations with the IFCC reference method (r ≥ 0.98). Relative average deviations ranged from −5.23 % to 3.71 %, within the acceptable biological variation limit. External quality assessment revealed high pass rates (94.9 %-98.7 %) across reagent groups, with significant improvements observed in some reagent groups from 2020 to 2023..

Conclusions

While the four LD measurement systems demonstrated good correlation with the IFCC reference method, some systems require further standardization. The study provides valuable insights into LD measurement accuracy and supports ongoing efforts to enhance laboratory testing comparability.

查看原文本刊更多论文

基于外部质量评估的 LDH 测量和分析的可比性。

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

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.