Immunoassay-based biomarkers in atopic dermatitis

IF 2.9 3区医学 Q2 MEDICAL LABORATORY TECHNOLOGY

Clinica Chimica Acta Pub Date : 2025-10-09 DOI:10.1016/j.cca.2025.120634

Khalid Orayj , Vijaya Paul Samuel , Shakir Saleem , Sahithya Ravali Ravula , Haider Ali , Gaurav Gupta , K. Benod Kumar , Pran Kishore Deb , Kumarappan Chidambaram

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引用次数: 0

Abstract

Atopic dermatitis (AD) is a persistent and recurring inflammatory skin condition that affects 204 million people worldwide, with prevalence rates of 11.1 % among children and 6.3 % among adults. This condition affects multiple systems, resulting in pruritus, skin barrier defects, and a Th2-driven immune imbalance, which consequently leads to significant costs and a diminished quality of life. To enhance precision medicine in laboratory diagnostics, it is essential to identify a neutral biomarker that can complement traditional severity assessments, such as SCORAD and EASI, for the diverse phenotypes and endotypes of AD. This narrative review examines immunoassay-based biomarkers with proven clinical validity in diagnostic laboratory medicine. Biomarkers such as TARC/CCL17, IL-13, IL-22, IL-31, SCCA1/SCCA2, and periostin are assessed using various tests, including ELISA, bead-based multiplexing, proximity extension, and highly sensitive digital methods. The samples included serum, plasma, and skin samples obtained through tape-stripping and microneedle collection. The parameters for analytical validation included detection and quantification limits, reportable range, precision, linearity, carryover effects, method comparison, interference assessment, heterophile antibody effects, calibration, and external quality standards. Clinical performance assessment uses measures such as the area under the curve (AUC), likelihood ratios, and decision limitations. Conventional biomarkers, including total IgE, peripheral eosinophil count, and tryptase, show less clinical utility than new biomarkers. Critical implementation requirements include standardized skin sample collection methods, population-specific reference intervals, inter-platform harmonization, and consensus-based cut-off values with clinical significance. This review outlines an evidence-based plan for incorporating reliable AD biomarker tests into current diagnostic methods to facilitate precise skin treatment and personalized care.

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特应性皮炎中基于免疫测定的生物标志物。

特应性皮炎（AD）是一种持续和反复发作的炎症性皮肤疾病，全世界有2.04亿人受到影响，儿童患病率为11.1 %，成人患病率为6.3 %。这种情况会影响多个系统，导致瘙痒、皮肤屏障缺陷和th2驱动的免疫失衡，从而导致巨大的成本和生活质量下降。为了加强实验室诊断中的精准医学，必须确定一种中性生物标志物，可以补充传统的严重程度评估，如SCORAD和EASI，用于不同表型和内型的AD。这篇叙述性的综述研究了基于免疫测定的生物标志物，在诊断实验室医学中具有临床有效性。生物标记物如TARC/CCL17、IL-13、IL-22、IL-31、SCCA1/SCCA2和骨膜蛋白使用各种测试进行评估，包括ELISA、基于头部的多路复用、接近扩展和高灵敏度的数字方法。样品包括通过胶带剥离和微针采集的血清、血浆和皮肤样品。分析验证的参数包括检测和定量限、报告范围、精密度、线性度、结转效应、方法比较、干扰评估、异源抗体效应、校准和外部质量标准。临床表现评估使用诸如曲线下面积（AUC）、似然比和决策限制等措施。传统的生物标志物，包括总IgE、外周嗜酸性粒细胞计数和胰蛋白酶，在临床应用上不如新的生物标志物。关键的实施要求包括标准化的皮肤样本采集方法、特定人群的参考区间、平台间的协调以及基于共识的具有临床意义的临界值。这篇综述概述了一个基于证据的计划，将可靠的AD生物标志物测试纳入当前的诊断方法，以促进精确的皮肤治疗和个性化护理。

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

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.