用于吸入性特异性IgE的综合17种过敏原面板：优化定量测定的可靠性与验证

文献信息

中文摘要

引言： 特应性疾病，如哮喘和过敏性鼻炎，是由对环境过敏原的免疫球蛋白E（IgE）反应介导的慢性炎症性疾病。检测过敏原特异性IgE对于诊断致敏和指导临床管理至关重要。因此，过敏原特异性IgE测定已成为临床诊断和过敏研究中不可或缺的工具。CHORUS特异性IgE捕获测定是自动化免疫测定，旨在定量人血清中多达17种过敏原特异性IgE抗体。在本研究中，对优化的测定版本进行了评估，以确定其在灵敏度、特异性、精密度和整体可靠性方面的分析性能。
方法： 每种测定均使用疑似IgE介导致敏患者的人血清进行测试。根据现行指南确定检测限（LoD）和定量限（LoQ）。在批内、批间、批次内和批次间条件下评估精密度和重复性，变异系数（CV）≤15%视为可接受。使用Spearman相关性、Passing-Bablok回归和Bland-Altman分析与ImmunoCAP进行方法比较。
结果： 每批次72次重复测量中，LoD为0.08 kU/L，可定量范围为0.10-50.0 kU/L。灵敏度范围为90.2%（Phleum pratense）至97.0%（Meadow Grass），而特异性范围为90.2%（Dermatophagoides pteronyssinus）至100%（Alternaria alternata、Betula verrucosa、Ray Grass、Meadow Grass）。所有测定均表现出高精密度（CV <15%），并与ImmunoCAP强相关（Spearman's r > 0.700）。离群值罕见，且大多出现在10 kU/L以上。
结论： CHORUS特异性IgE捕获测定表现出高分析准确性和可重复性，支持其用于常规临床测定过敏原特异性IgE的可靠性。

英文摘要

INTRODUCTION: Atopic diseases, such as asthma and allergic rhinitis, are chronic inflammatory disorders mediated by immunoglobulin E (IgE) responses to environmental allergens. Detecting allergen-specific IgE is essential for diagnosing sensitization and guiding clinical management. Allergen-specific IgE assays have, thus, become indispensable in clinical diagnostics and allergy research. The CHORUS Specific IgE Capture assays are automated immunoassays designed to quantify up to 17 allergen-specific IgE antibodies in human serum. In this study, optimized versions of the assays have been evaluated to determine their analytical performance in terms of sensitivity, specificity, precision, and overall reliability.
METHODS: Each assay was tested using human serum from patients with suspected IgE-mediated sensitization. Limits of detection (LoD) and quantitation (LoQ) were determined according to current guidelines. Precision and repeatability were assessed across intra-run, inter-run, intra-batch, and inter-batch conditions, with coefficients of variation (CV) ≤15% considered acceptable. Method comparison with ImmunoCAP was performed using Spearman's correlation, Passing-Bablok regression, and Bland-Altman analysis.
RESULTS: Across 72 replicate measurements per lot, the LoD was 0.08 kU/L, with a quantifiable range of 0.10-50.0 kU/L. Sensitivity ranged from 90.2% (Phleum pratense) to 97.0% (Meadow Grass), while specificity ranged from 90.2% (Dermatophagoides pteronyssinus) to 100% (Alternaria alternata, Betula verrucosa, Ray Grass, Meadow Grass). All assays demonstrated high precision (CV <15%), and strong correlation with ImmunoCAP (Spearman's r > 0.700). Outliers were rare and mostly observed above 10 kU/L.
CONCLUSION: CHORUS Specific IgE Capture assays exhibit high analytical accuracy and reproducibility, supporting their reliability for routine clinical determination of allergen-specific IgE.