Evaluation of an automated assay for eosinophil-derived neurotoxin in serum

IF 2.5 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinical biochemistry Pub Date : 2025-01-25 DOI:10.1016/j.clinbiochem.2025.110890

Carley Karsten , Theodore Stier , Christina Wood-Wentz , Carin Smith , Yifei K. Yang , Melissa Snyder

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Abstract

Introduction

Eosinophil-derived neurotoxin (EDN) is a promising biomarker for eosinophil activation during inflammatory responses. Here we evaluate the analytical performance of an automated fluorescence enzyme immunoassay for EDN in serum and explore its relationship with eosinophil counts in both healthy participants and those with eosinophilic conditions.

Materials and Methods

Paired serum samples were collected from individuals for whom a complete blood count with differential was ordered. EDN was measured using the ImmunoCAP EDN Assay Kit (research use only, Phadia AB / provided by Thermo Fisher Scientific) and 40 samples were also measured using an ELISA kit (research use only, ALPCO).

Results

The analytical measurement range of the ImmunoCAP assay was 2.6–200 µg/L. The imprecision across different EDN concentrations was ≤ 7.0 %. Stability and preanalytical requirements were determined. To minimize ex vivo degranulation and false elevation of EDN levels, serum should be removed from the cell pellet immediately after centrifugation. There was strong correlation for EDN measurements between ImmunoCAP and the comparative ELISA (r = 0.974), although a significant bias was observed. A 95th percentile reference range in 180 presumed healthy adults was calculated at 101 µg/L. Overall EDN was significantly higher in serum from patients with elevated circulating eosinophil counts (median = 120.0; P < 0.0001). However, individual patients may present with discordant presentation of eosinophil counts and EDN concentration.

Conclusions

Together these results demonstrate that the ImmunoCAP EDN Assay Kit can reliably measure EDN in serum and may be useful for the evaluation of patients with conditions associated with hypereosinophilia.

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简介嗜酸性粒细胞衍生神经毒素（EDN）是炎症反应期间嗜酸性粒细胞活化的一种很有前景的生物标记物。在此，我们评估了血清中 EDN 自动荧光酶免疫分析仪的分析性能，并探讨了它与健康人和嗜酸性粒细胞病患者中嗜酸性粒细胞计数的关系：从需要进行全血细胞计数和差值检查的人群中采集配对血清样本。使用 ImmunoCAP EDN 分析试剂盒（仅供研究使用，Phadia AB / Thermo Fisher Scientific 提供）测量 EDN，同时使用 ELISA 试剂盒（仅供研究使用，ALPCO）测量 40 份样本：结果：ImmunoCAP 分析法的分析测量范围为 2.6-200 µg/L。不同浓度 EDN 的不精确度≤ 7.0%。确定了稳定性和分析前要求。为尽量减少体内脱颗粒和 EDN 水平的错误升高，离心后应立即从细胞团中去除血清。ImmunoCAP与对比ELISA的EDN测量结果有很强的相关性（r = 0.974），但也观察到了明显的偏差。在 180 名假定健康的成年人中计算出的第 95 百分位数参考范围为 101 µg/L。在循环嗜酸性粒细胞计数升高的患者血清中，总的 EDN 值明显较高（中位数 = 120.0；P < 0.0001）。然而，个别患者的嗜酸性粒细胞计数和 EDN 浓度可能不一致：这些结果表明，ImmunoCAP EDN 检测试剂盒能可靠地检测血清中的 EDN，可用于评估嗜酸性粒细胞过多相关疾病的患者。

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 biochemistry 医学-医学实验技术

CiteScore

5.10

自引率

0.00%

发文量

151

审稿时长

25 days

期刊介绍： Clinical Biochemistry publishes articles relating to clinical chemistry, molecular biology and genetics, therapeutic drug monitoring and toxicology, laboratory immunology and laboratory medicine in general, with the focus on analytical and clinical investigation of laboratory tests in humans used for diagnosis, prognosis, treatment and therapy, and monitoring of disease.