ISAC 与 ALEX 多重检测系统的全面比较。

A comprehensive comparison between ISAC and ALEX multiplex test systems.

机构信息

Microvida Laboratory of Medical Microbiology and Immunology, Elisabeth-TweeSteden Ziekenhuis, Tilburg, Noord-Brabant, Netherlands.

Department of Allergology, Elisabeth-TweeSteden Ziekenhuis, Tilburg, Noord-Brabant, Netherlands.

出版信息

Clin Chem Lab Med. 2022 Apr 27;60(7):1046-1052. doi: 10.1515/cclm-2022-0191. Print 2022 Jun 27.

DOI:10.1515/cclm-2022-0191

PMID:35470638

Abstract

OBJECTIVES

Diagnosis of type I hypersensitivity is based on anamnesis, provocation as well as blood- and skin testing. Multiplex specific IgE (sIgE) testing enables determination of sIgE antibodies against multiple recombinant or purified natural allergen components. The aim of this study was to evaluate the performance of the novel ALEX (Allergy Explorer, ALEX test introduced on the market November 2019) multiplex platform and to compare it with the ImmunoCAP ISAC test system.

METHODS

Serum samples of 49 patients, routinely determined with ISAC, were selected based on positive results covering in total most of the 112 ISAC components. Cohen's kappa, negative percent agreement (NPA), and positive percent agreement (PPA) of ALEX data compared to ISAC data (as a non-reference standard) were computed for those allergen components present on both platforms (n=103). Furthermore, in some samples sIgE results against allergen extracts and/or -components tested with either ImmunoCAP (ThermoFisher) or IMMULITE (Siemens) were available and compared to ALEX results.

RESULTS

The overall agreement between ISAC and ALEX common allergen components was 94%. NPA and PPA were respectively 95 and 90%. Kappa values differed for specific allergen groups and varied between 0.60 and 0.92 showing moderate to almost perfect agreement. Of the qualitative discrepancies between ALEX and ISAC, 59% were related to weak positive results i.e. results under 1 kUA/L or 1 ISU, respectively.

CONCLUSIONS

The method comparison between ISAC and ALEX multiplex tests showed a high concordance for those allergen components present on both platforms.

摘要

目的

I 型超敏反应的诊断基于病史、激发试验以及血液和皮肤测试。多重特异性 IgE（sIgE）检测可确定针对多种重组或纯化天然过敏原成分的 sIgE 抗体。本研究旨在评估新型 ALEX（过敏原探索器，于 2019 年 11 月推出市场的 ALEX 测试）多重平台的性能，并将其与 ImmunoCAP ISAC 测试系统进行比较。

方法

根据涵盖 ISAC 检测的总共有 112 种 ISAC 成分的阳性结果，从常规使用 ISAC 检测的 49 名患者的血清样本中选择。对于两种平台均存在的过敏原成分（n=103），计算 ALEX 数据与 ISAC 数据（作为非参考标准）的 Cohen's kappa、阴性百分比一致率（NPA）和阳性百分比一致率（PPA）。此外，在一些样本中，还可获得针对过敏原提取物和/或使用 ImmunoCAP（赛默飞世尔）或 IMMULITE（西门子）检测的过敏原成分的 sIgE 结果，并与 ALEX 结果进行比较。

结果

ISAC 和 ALEX 常见过敏原成分的总体一致性为 94%。NPA 和 PPA 分别为 95%和 90%。特定过敏原组的 Kappa 值不同，范围在 0.60 到 0.92 之间，表明存在中度至几乎完美的一致性。在 ALEX 和 ISAC 之间的定性差异中，59%与弱阳性结果有关，即分别低于 1 kUA/L 或 1 ISU 的结果。