阿尔茨海默病四种核心脑脊液生物标志物的三种常用免疫测定法和一种LC-MS/MS测定法的方法比较和重新校准：一项统一的探索性研究。

IF 3.2 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2025-05-11 DOI:10.1016/j.cca.2025.120352

Yutong Zou , Xiaoli Ma , Chenhui Mao , Shanshan Chu , Tianyi Wang , Wei Jin , Yifei Wang , Songlin Yu , Jing Gao , Ling Qiu

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引用次数: 0

摘要

背景：我们旨在比较脑脊液（CSF）中β-淀粉样蛋白1-42 （a - β1-42）、β-淀粉样蛋白1-40 （a - β1-40）、总tau蛋白和p-tau181四种检测方法的分析性能，并评估其在阿尔茨海默病（AD）诊断中的临床应用价值。方法：比较四种方法的测定浓度和分析性能，包括精密度、线性度和准确度。基于不同的检测方法对淀粉样正电子发射断层扫描（PET）状态的判别精度进行了评估。结果：基于四种测定法的生物标志物的测量结果显示出良好的一致性，但仍有显着差异。对于PET状态的判别，Aβ1-42/p-tau181的比值比其他生物标志物具有更好的诊断性能，液相色谱串联质谱（LC-MS/MS）和Lumipulse G检测在每种检测中结合所有生物标志物表现更好。结论：利用前分析和测量程序的统一和标准化，在不同的分析和实验室中获得一致和可比较的结果是至关重要的。

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Method comparison and re-calibration of three top-used immunoassays and one LC-MS/MS assay for four core cerebrospinal fluid biomarkers of Alzheimer’s disease: an explorative study for harmonization

Background

We aimed to compare the analytical performance of four assays, for measuring β-amyloid 1–42 (Aβ1-42), β-amyloid 1–40 (Aβ1-40), total tau, and p-tau181 in cerebrospinal fluid (CSF) and evaluate the clinical performance for the diagnosis of Alzheimer’s disease (AD).

Methods

The measured concentrations and analytical performance, including precision, linearity, and accuracy of four assays were compared. The discriminative accuracy for amyloid positron emission tomography (PET) status based on different assays was evaluated.

Results

The measurements of the four biomarkers based on the four assays demonstrated favorable agreement, while still significantly different. For the discrimination of PET status, the ratio of Aβ1-42/p-tau181 showed better diagnostic performance than other biomarkers, with liquid chromatography tandem-mass spectrometry (LC-MS/MS) and Lumipulse G assays performing better when combining all biomarkers for each assay.

Conclusions

It is crucial to promote the harmonization and standardization of pre-analytical and measurement procedures to achieve consistent and comparable results in different assays and laboratories.

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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.