Wojtalewicz N, Goseberg S, Kabrodt K, Schellenberg I
Center of Life Sciences, AG IBAS, Hochschule Anhalt, Stenzfelder Allee 28, 06406 Bernburg (Saale), Germany.
INSTAND e.V., Düsseldorf, Germany.
Allergo J Int. 2017;26(2):43-52. doi: 10.1007/s40629-016-0005-8. Epub 2017 Jan 18.
Even though allergies are an important health issue, wide manufacturer-dependent differences in the detected amounts of allergen-specific IgE (sIgE) have repeatedly been found. These discrepancies hinder diagnostics and research into clinically significant cutoff points for life-threatening symptoms.
To evaluate whether the reported differences have led to changes in diagnostic testing, we analyzed data from six years of round robin testing (RRT, also known as proficiency testing) at the Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e.V. (Society for Promoting Quality Assurance in medical Laboratories) for the important allergen sources bee venom, wasp venom, and birch pollen. The results of the four main suppliers of in vitro diagnostic sIgE testing were compared in a pseudo-anonymized form using overlay images of box plot graphs for the semiquantitative data and allergen class results. Coefficients of variation (CV) were obtained to study the development of interlaboratory comparability.
We found that the large differences between the manufacturer collectives remained constant between January 2010 and April 2015 without any real improvement. The CVs were good for two of the four analyzed suppliers, one was marginal and one above the quality level of 20%.
The numerous publications that have found discrepancies in the sIgE results of the different suppliers did not change the status quo within the last six years. Unfortunately, this is unlikely to change until there is a characterized standard material with known values of sIgE.
尽管过敏是一个重要的健康问题，但在检测到的过敏原特异性IgE（sIgE）量方面，一直存在因制造商不同而产生的巨大差异。这些差异阻碍了对危及生命症状的临床显著临界值的诊断和研究。
为了评估所报告的差异是否导致了诊断测试的变化，我们分析了德国医学实验室质量保证促进协会（ Gesellschaft zur Förderung der Qualitätssicherung in medizinischen Laboratorien e.V.）六年来的室间比对测试（RRT，也称为能力验证测试）数据，涉及重要的过敏原来源——蜂毒、黄蜂毒和桦树花粉。使用箱线图的叠加图像以伪匿名形式比较了体外诊断sIgE测试的四个主要供应商的半定量数据和过敏原类别结果。获得变异系数（CV）以研究实验室间可比性的发展情况。
我们发现，在2010年1月至2015年4月期间，制造商群体之间的巨大差异一直存在，没有任何实质性改善。四个被分析供应商中的两个CV值良好，一个处于临界状态，一个高于20%的质量水平。
众多发现不同供应商sIgE结果存在差异的出版物在过去六年中并未改变现状。不幸的是，在有具有已知sIgE值的标准化材料之前，这种情况不太可能改变。
