评估双样品口服巧克力激发试验的性能：HepQuant DuO试验

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2025-04-20 DOI:10.1016/j.cca.2025.120325

Michael P. McRae , Touraj Shokati , Uwe Christians , Steve M. Helmke , Gregory T. Everson

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引用次数: 0

摘要

背景：目前评估肝脏健康的方法是使用非特异性血液检查、纤维化替代品和侵入性手术，这些方法都不能直接测量肝功能和生理。经过验证的HepQuant SHUNT测试可量化肝功能和生理，并与临床结果相关。在这里，我们提出了一个简化版本的可靠性，双样品口服巧克力挑战（HepQuant DuO）测试。方法采用分流- v研究中代表各种肝脏疾病病因的样本进行实验，以评估测试的可靠性。我们将HepQuant DuO测试分析物的测量值与先前验证的HepQuant SHUNT测试进行了比较。分析物测量值和HepQuant DuO测试参数的精密度和不精密度（%CV）在四天内进行评估，每天两次运行，每次运行三个重复，使用双向嵌套分层方差分析。对加入内源性12c -胆酸的样品进行了分析特异性评估。结果所有样品均符合预先设定的方法比较接受标准，平均偏差为2.6%，表明HepQuant DuO和SHUNT的分析方法具有等效性。对于13C-和d4-巧克力，所有HepQuant DuO测试参数的总不精度范围为0.6%至2.1%。在样品中加入高浓度的12c -胆酸，与对照组相比，其干扰率变化的百分比为3.2%或更低。结论本文所述的研究建立了HepQuant DuO检测在精度、分析特异性方面的可靠性，并与经过验证的HepQuant SHUNT检测一致。还描述了可报告的范围和参考间隔。

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Assessment of the performance of a dual-sample oral cholate challenge test: The HepQuant DuO test

Background

Liver health is currently evaluated using nonspecific blood tests, fibrosis surrogates, and invasive procedures, none of which directly measure liver function and physiology. The validated HepQuant SHUNT test quantifies liver function and physiology and is linked to clinical outcomes. Herein we present the reliability of a simplified version, the dual-sample oral cholate challenge (HepQuant DuO) test.

Methods

Samples from the SHUNT-V study representing various liver disease etiologies were used in experiments to assess test reliability. We compared the HepQuant DuO test analyte measurements relative to the previously validated HepQuant SHUNT test. Precision and imprecision (%CV) of analyte measurements and HepQuant DuO test parameters were evaluated over four days, with two runs per day and three replicates per run, using two-way nested hierarchical ANOVA. Analytical specificity was evaluated in samples spiked with endogenous ¹²C-cholic acid.

Results

All samples met the prespecified method comparison acceptance criteria with a mean bias of 2.6 %, demonstrating equivalency between the analytical methods of HepQuant DuO and SHUNT. Total imprecision across all HepQuant DuO test parameters, for both 13C- and d4-cholate, ranged from 0.6 % to 2.1 %. Samples spiked with high concentrations of ¹²C-cholic acid demonstrated lack of interference with a percent change relative to controls of 3.2 % or less.

Conclusions

The studies described herein established the reliability of the HepQuant DuO test in terms of precision, analytical specificity, and agreement with the validated HepQuant SHUNT test. Reportable ranges and reference intervals are also described.

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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.