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使用UNICAP 100测定总IgE和特异性IgE:与CAP系统的比较研究

Determination of total and specific IgE using UNICAP 100: comparative study with the CAP system.

作者信息

Cots P, Pena J M, Botey J, Eseverri J L, Marín A, Ras R

机构信息

Allergy and Paediatric Clinical Immunology Department, Maternity and Children's University Hospital, Vall d'Hebrón, Barcelona.

出版信息

Allergol Immunopathol (Madr). 1998 Sep-Oct;26(5):223-7.

PMID:9885729
Abstract

The methods of serum determination of specific IgE to different allergens have showed lower diagnostic sensitivity than the alternative in vivo methods, the skin tests. The CAP system from Pharmacia, owing to its solid phase, has ameliorated this disadvantage, showing in various studies greater diagnostic sensitivity than the classic RAST, without affecting specificity. However, this system is still semi-automatic and requires daily calibration. UNICAP 100 is a completely automatic autoanalyser for total IgE, specific IgE and Eosinophil Cationic Protein, which combines the high sensitivity of the CAP system with complete automation and monthly calibration. The aim of the present study is to assess the practicality and reliability of UNICAP 100, when compared to the CAP System, for the determination of total IgE and specific IgE, as well as the sensitivity and diagnostic specificity; using as a reference skin tests in 150 paediatric patients. The coefficients of variation in the study of intraseries imprecision ranged between 2.1% and 3.6% for total IgE and between 2.2% and 5.1% for specific IgE, depending on the allergen and the level studied. The intraseries imprecision ranged between 3.3% and 7.7% for total IgE and between 5.2% and 8.9% for specific IgE. The coefficients of correlation of the study of interchangeability with the results of the CAP System varied between 0.985 and 0.998, all the allergens tested (9) being interchangeable. Finally, the diagnostic sensitivity varied between 70% and 95% and the specificity between 87% and 100%. In conclusion, UNICAP 100 showed results that were interchangeable with the CAP System, noticeably improving the benefits owing to its complete automation and its calibration system.

摘要

血清中不同过敏原特异性IgE的检测方法显示,其诊断敏感性低于替代性的体内检测方法——皮肤试验。法玛西亚公司的CAP系统因其固相特性,改善了这一缺点,在多项研究中显示出比传统放射变应原吸附试验(RAST)更高的诊断敏感性,且不影响特异性。然而,该系统仍是半自动的,需要每日校准。UNICAP 100是一款用于总IgE、特异性IgE和嗜酸性粒细胞阳离子蛋白检测的全自动分析仪,它将CAP系统的高敏感性与完全自动化以及每月校准相结合。本研究的目的是评估UNICAP 100与CAP系统相比,在检测总IgE和特异性IgE时的实用性和可靠性,以及其敏感性和诊断特异性;以150名儿科患者的皮肤试验作为参考。根据所研究的过敏原和水平,系列内不精密度研究中总IgE的变异系数在2.1%至3.6%之间,特异性IgE在2.2%至5.1%之间。系列内不精密度总IgE在3.3%至7.7%之间,特异性IgE在5.2%至8.9%之间。与CAP系统结果的互换性研究的相关系数在0.985至0.998之间,所有测试的过敏原(9种)都具有互换性。最后,诊断敏感性在70%至95%之间,特异性在87%至100%之间。总之,UNICAP 100显示出与CAP系统可互换的结果,因其完全自动化和校准系统而显著改善了优势。

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