Performance evaluation of enzymatic total bile acid (TBA) routine assays: systematic comparison of five fifth-generation TBA cycling methods and their individual bile acid recovery from HPLC-MS/MS reference.

IF 3.8 2区医学 Q1 MEDICAL LABORATORY TECHNOLOGY

Clinical chemistry and laboratory medicine Pub Date : 2024-11-29 DOI:10.1515/cclm-2024-1029

Matthias Grimmler, Tobias Frömel, Angelique Masetto, Holger Müller, Tina Leber, Christoph Peter

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引用次数: 0

Abstract

Objectives: Serum total bile acid (TBA) levels are frequently assessed in clinical routine for the early detection of hepatobiliary dysfunction. However, the comparability of current 5th-generation TBA cycle assays based on 3α-hydroxysteroid dehydrogenase (3α-HSD) and their ability to quantify individual bile acids has not been systematically addressed.

Methods: Patient serum samples (n=60) across the diagnostically relevant TBA range (1-200 μmol/L) were analyzed using five TBA routine assays from Abbott, DiaSys, Diazyme, Beijing Strong (BSBE) and Randox on the same analyzer (BioMajesty^® JCA-BM6010/C). The assays were compared using Passing-Bablok regression and the recovery of 11 individual BAs was evaluated against RP-HPLC-MS/MS as non-enzymatic reference method.

Results: Despite excellent correlation (Spearman r ≥0.99), the assays showed proportional differences (slope) ranging from 0.99 (BSBE/Randox) to 1.24 (Abbott/DiaSys). The assays showed considerable deviation in the recovery of competitor's calibrators and controls, and large heterogeneity in the recovery of individual BAs, with mean deviations from reference value between 13 % (DiaSys) and 42 % (Abbott). CA and TCA were measured most accurately and consistently, whereas GCA, CDCA, DCA, UDCA, and conjugates were over- or undermeasured to varying degrees.

Conclusions: The linear relationship and constant proportional bias between all five routine assays enable the harmonization of TBA measurements up to 60 μmol/L. However, for patient samples with high TBA levels and disease-specific overrepresentation of individual BAs, harmonization will require: i) optimized reaction conditions to equalize substrate specificity, and ii) calibration to a common, commutable reference material with well-defined BA composition instead of internal standards spiked with different BAs.

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酶促总胆汁酸（TBA）常规测定方法的性能评价：系统比较5种第五代TBA循环方法及其在HPLC-MS/MS参考条件下单个胆汁酸回收率。

目的：血清总胆汁酸（TBA）水平在临床常规中经常被评估，用于早期发现肝胆功能障碍。然而，目前基于3α-羟基类固醇脱氢酶（3α-HSD）的第五代TBA循环测定法的可比性及其量化单个胆汁酸的能力尚未得到系统的解决。方法：采用雅培、DiaSys、Diazyme、北京斯特朗（BSBE）和Randox 5种TBA常规检测方法，在同一台生化分析仪（BioMajesty®JCA-BM6010/C）上对诊断相关TBA范围（1-200 μmol/L）内的60例患者血清样本进行分析。采用pass - bablok回归法进行比较，并以反相高效液相色谱-质谱联用（RP-HPLC-MS/MS）作为非酶参比法评价11个BAs的回收率。结果：尽管相关性很好（Spearman r≥0.99），但测定结果显示比例差异（斜率）范围为0.99 （BSBE/Randox）至1.24 （Abbott/DiaSys）。分析显示竞争对手的校准器和对照品的回收率存在相当大的偏差，单个BAs的回收率存在很大的异质性，与参考值的平均偏差在13 % （DiaSys）和42 % （Abbott）之间。CA和TCA的测量最准确和一致，而GCA， CDCA， DCA， UDCA和共轭物在不同程度上被高估或低估。结论：五种常规测定方法之间的线性关系和恒定的比例偏差使TBA测量值达到60 μmol/L。然而，对于TBA水平高的患者样本和个别BA的疾病特异性过度代表，协调将需要：i)优化反应条件以平衡底物特异性，ii)校准为具有明确BA组成的通用可交换参考物质，而不是添加不同BA的内部标准。

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

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!