Evaluation of the EUROIMMUN automated chemiluminescence immunoassays for measurement of four core biomarkers for Alzheimer’s disease in cerebrospinal fluid

IF 1.7 Q3 MEDICAL LABORATORY TECHNOLOGY

Practical Laboratory Medicine Pub Date : 2024-08-01 DOI:10.1016/j.plabm.2024.e00425

Katharina Römpler , Philipp Arendt , Britta Brix , Viola Borchardt-Lohölter , Anette Schulz , Mandy Busse , Stefan Busse

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引用次数: 0

Abstract

Introduction

Robust immunoassays for quantification of Alzheimer's disease (AD)-specific biomarkers are required for routine diagnostics. We report analytical performance characteristics of four new chemiluminescence immunoassays (ChLIA, EUROIMMUN) running on closed, fully automated random-access instruments for quantification of Aβ_1-40, Aβ_1-42, tTau, and pTau(181) in human cerebrospinal fluid (CSF).

Methods

ChLIAs were validated according to the guidelines of the Clinical and Laboratory Standards Institute (CLSI). Optimal cut-offs for biomarkers and biomarker ratios were determined using samples from 219 AD patients and 220 patients with AD-related symptoms. For performance comparison, biomarker concentrations were measured in 110 diagnostic leftover samples using the ChLIAs and established Lumipulse G assays (Fujirebio).

Results

All ChLIAs met CLSI criteria. Overall agreement between assays was 89.0%–97.3 % with highly correlating results (Pearson's correlation coefficients: 0.82–0.99). Passing-Bablok regression analysis revealed systematic differences.

Discussion

EUROIMMUN ChLIAs showed good analytical performances and represent new valuable tools for diagnostics of AD.

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评估 EUROIMMUN 自动化学发光免疫测定法，用于测量脑脊液中阿尔茨海默病的四种核心生物标记物

导言：常规诊断需要可靠的免疫测定来量化阿尔茨海默病（AD）特异性生物标记物。我们报告了在封闭式全自动随机接入仪器上运行的四种新型化学发光免疫测定（ChLIA，EUROIMMUN）的分析性能特点，它们可用于定量检测人脑脊液（CSF）中的Aβ1-40、Aβ1-42、tTau和pTau(181)。使用 219 例 AD 患者和 220 例 AD 相关症状患者的样本确定了生物标记物和生物标记物比率的最佳临界值。为了进行性能比较，使用 ChLIA 和现有的 Lumipulse G 检测方法（Fujirebio）测量了 110 份诊断残留样本中的生物标记物浓度。各检测方法之间的总体一致性为 89.0%-97.3 %，结果高度相关（皮尔逊相关系数：0.82-0.99）。Passing-Bablok 回归分析显示存在系统性差异。

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

Practical Laboratory Medicine Health Professions-Radiological and Ultrasound Technology

CiteScore

3.50

自引率

0.00%

发文量

审稿时长

7 weeks

期刊介绍： Practical Laboratory Medicine is a high-quality, peer-reviewed, international open-access journal publishing original research, new methods and critical evaluations, case reports and short papers in the fields of clinical chemistry and laboratory medicine. The objective of the journal is to provide practical information of immediate relevance to workers in clinical laboratories. The primary scope of the journal covers clinical chemistry, hematology, molecular biology and genetics relevant to laboratory medicine, microbiology, immunology, therapeutic drug monitoring and toxicology, laboratory management and informatics. We welcome papers which describe critical evaluations of biomarkers and their role in the diagnosis and treatment of clinically significant disease, validation of commercial and in-house IVD methods, method comparisons, interference reports, the development of new reagents and reference materials, reference range studies and regulatory compliance reports. Manuscripts describing the development of new methods applicable to laboratory medicine (including point-of-care testing) are particularly encouraged, even if preliminary or small scale.