验证一种商用过敏原微阵列平台，用于检测呼吸道和植物源性食物过敏原的特异性免疫球蛋白 E。

Validation of a commercial allergen microarray platform for specific immunoglobulin E detection of respiratory and plant food allergens.

机构信息

Department of Allergy and Clinical Immunology, Clínica Universidad de Navarra, Pamplona, Spain.

Department of Allergy and Clinical Immunology, Clínica Universidad de Navarra, Pamplona, Spain; Research Network on Asthma, Drug Adverse Reactions and Allergy (ARADyAL, Red de Investigación en Asma, Reacciones Adversas a Fármacos y Alergia), Spain; Navarra Health Research Institute (IDISNA, Instituto de Investigación Sanitaria de Navarra), Pamplona, Spain.

出版信息

Ann Allergy Asthma Immunol. 2022 Mar;128(3):283-290.e4. doi: 10.1016/j.anai.2021.11.019. Epub 2021 Dec 1.

DOI:10.1016/j.anai.2021.11.019

PMID:34863952

Abstract

BACKGROUND

As the use of multiplex-specific immunoglobulin E (sIgE) detection methods becomes increasingly widespread, proper comparative validation assessments of emerging new platforms are vital.

OBJECTIVE

To evaluate the clinical and technical performance of a newly introduced microarray platform, Allergy Explorer (ALEX) (MacroArray Diagnostics), in the diagnosis of pollen (cypress, grass, olive), dust mite (Dermatophagoides pteronyssinus), mold (Alternaria alternata), fruit (apple, peach), and nut (walnut, hazelnut and peanut) allergies and to compare it with those of the ImmunoCAP Immuno Solid-phase Allergen Chip (ISAC) 112 microarray and the ImmunoCAP singleplex method (ThermoFisher Scientific).

METHODS

We enrolled 153 patients with allergy and 16 controls without atopy. The sIgE assays were conducted using ISAC112, ALEX version 2 (ALEX2), and ImmunoCAP for whole extracts and major components. Technical validation of ALEX2 was performed by measuring repeatability and interassay, interbatch, and interlaboratory reproducibility.

RESULTS

When measured globally (detection by 1 or more allergen components), ALEX2 had adequate sensitivity and specificity for most of the allergens studied, comparable in general with that of ISAC112 (except for olive pollen and walnut) and similar to that of ImmunoCAP whole extract measurements. Component-by-component analysis revealed comparable results for all techniques, except for Ole e 1 and Jug r 3, in both ISAC112 and ImmunoCAP comparisons, and Alt a 1, when compared with ISAC112. Continuous sIgE levels correlate with sIgE by ImmunoCAP. Good reproducibility and repeatability were observed for ALEX2.

CONCLUSION

ALEX2 has sound technical performance and adequate diagnostic capacity, comparable in general with that of ISAC112 and ImmunoCAP.

摘要

背景

随着多聚体特异性免疫球蛋白 E（sIgE）检测方法的应用越来越广泛，对新兴新平台进行适当的比较验证评估至关重要。

目的

评估新引入的微阵列平台 Allergy Explorer（ALEX）（MacroArray Diagnostics）在花粉（柏树、草、橄榄）、尘螨（屋尘螨）、霉菌（链格孢）、水果（苹果、桃）和坚果（核桃、榛子和花生）过敏诊断中的临床和技术性能，并将其与 ImmunoCAP Immuno Solid-phase Allergen Chip（ISAC）112 微阵列和 ImmunoCAP 单克隆方法（ThermoFisher Scientific）进行比较。

方法

我们招募了 153 名过敏患者和 16 名非特应性对照者。使用 ISAC112、ALEX 版本 2（ALEX2）和 ImmunoCAP 进行全提取物和主要成分的 sIgE 检测。通过测量重复性、批间、批内和实验室间重现性来对 ALEX2 进行技术验证。

结果

当总体测量（通过 1 种或多种过敏原成分检测）时，ALEX2 对大多数研究的过敏原具有足够的敏感性和特异性，总体上与 ISAC112 相当（除了橄榄花粉和核桃），与 ImmunoCAP 全提取物测量相似。对所有技术进行成分分析，除了 Ole e 1 和 Jug r 3 在 ISAC112 和 ImmunoCAP 比较中以及 Alt a 1 在与 ISAC112 比较中，结果相当，而在与 ISAC112 比较时，连续 sIgE 水平与 ImmunoCAP 的 sIgE 相关。ALEX2 具有良好的重现性和重复性。