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通过连续随机接入免疫分析仪测量的变应原特异性IgE:批间比较及与皮肤试验的一致性

Allergen-specific IgE measured by a continuous random-access immunoanalyzer: interassay comparison and agreement with skin testing.

作者信息

Ollert Markus, Weissenbacher Stephanie, Rakoski Jürgen, Ring Johannes

机构信息

Department of Dermatology and Allergy, Biederstein, Germany.

出版信息

Clin Chem. 2005 Jul;51(7):1241-9. doi: 10.1373/clinchem.2004.046565. Epub 2005 May 19.

Abstract

BACKGROUND

Our aims were to evaluate the performance of a fully automated system for measuring circulating allergen-specific IgE (sIgE) against an established in vitro assay and to assess the system's diagnostic accuracy against objective clinical criteria for identifying sensitization to specific allergens.

METHODS

Using both the IMMULITE 2000 Allergy system (IML) and an assay based on the widely used ImmunoCAP technology (CAP), we measured sIgE in serum samples from 169 persons with suspected allergies to airborne or insect venom allergens. Skin testing outcome served as the clinical comparison method.

RESULTS

Interassay classification agreement between the IML and CAP, relative to the usual allergen-specific IgE cutoff of 0.35 kIU/L, ranged from 76% (yellow jacket venom) to 95% (orchard grass); agreement was 88.3% for all 9 allergens combined (766 results). The 90 discordant results, when resolved by skin testing, showed better agreement with the IML (72%) than with the CAP (28%). Compared with skin testing, for each of the 9 allergens studied, the area under the ROC curve was at least as large for the IML as for the CAP, reflecting in part the more extensive working range of the IML (0.10-100 kIU/L vs 0.35-100 kIU/L for CAP).

CONCLUSION

Laboratory testing for sIgE can be performed on a fully automated, random-access system with an extended working range and with diagnostic accuracy for representative allergens equivalent to or better than that of the semiautomated CAP technology.

摘要

背景

我们的目的是评估一种全自动系统检测循环中过敏原特异性IgE(sIgE)的性能,并与一种既定的体外检测方法进行比较,同时根据识别对特定过敏原致敏的客观临床标准评估该系统的诊断准确性。

方法

我们使用免疫发光2000过敏检测系统(IML)和基于广泛应用的免疫捕获技术(CAP)的检测方法,对169名怀疑对空气传播或昆虫毒液过敏原过敏的患者血清样本中的sIgE进行检测。皮肤试验结果作为临床对照方法。

结果

相对于通常的过敏原特异性IgE临界值0.35 kIU/L,IML和CAP之间的检测间分类一致性范围为76%(黄蜂毒液)至95%(果园草);9种过敏原综合起来的一致性为88.3%(766个结果)。通过皮肤试验解决的90个不一致结果显示,与IML的一致性更好(72%),而与CAP的一致性为28%。与皮肤试验相比,对于所研究的9种过敏原中的每一种,IML的ROC曲线下面积至少与CAP一样大,这部分反映了IML更广泛的工作范围(0.10 - 100 kIU/L,而CAP为0.35 - 100 kIU/L)。

结论

sIgE的实验室检测可以在具有扩展工作范围的全自动随机检测系统上进行,对于代表性过敏原的诊断准确性等同于或优于半自动CAP技术。

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