INSTAND e.V., Society for Promoting Quality Assurance in Medical Laboratories, Düsseldorf, Germany.
Institute of Bioanalytical Sciences (IBAS), Center of Life Sciences, Anhalt University of Applied Sciences, Bernburg, Germany.
Ann Allergy Asthma Immunol. 2018 Oct;121(4):490-495. doi: 10.1016/j.anai.2018.07.016. Epub 2018 Jul 17.
Even though allergies are an important health issue, the detected amount of allergen-specific IgE (sIgE) has differed widely between manufacturers in the past, and even as recently as this year. These discrepancies hinder diagnostics and can even impact allergen immunotherapy.
The aim of this study was to evaluate the development and status quo of the quality of in vitro diagnostic testing for house dust mites (HDM) and cat epithelium, 2 important indoor allergen sources.
We analyzed data on the allergen sources European HDM, American HDM, and cat epithelium, which were collected by the Society for Promoting Quality Assurance in Medical Laboratories (INSTAND e.V.) during 7 years as part of External Quality Assessment schemes (EQAs). A pseudoanonymized comparison was made of the semiquantitative data and allergen-class results of the 4 main suppliers of in vitro diagnostic sIgE tests. Coefficients of variation (CV) were determined in order to evaluate interlaboratory comparability.
In vitro allergy diagnostic testing for the major allergen sources HDM and cat epithelium still reveals manufacturer-dependent differences. Despite this, a cautious trend was found towards an alignment of the results and interlaboratory comparability, with the exception of 1 supplier.
Even though these results are promising, future EQAs have to be closely monitored to ensure this positive trend is not just a snapshot.
尽管过敏是一个重要的健康问题，但过去不同制造商检测到的过敏原特异性 IgE（sIgE）含量存在很大差异，甚至就在今年也是如此。这些差异阻碍了诊断，甚至可能影响过敏原免疫治疗。
本研究旨在评估室内过敏原来源——屋尘螨（HDM）和猫上皮细胞的体外诊断检测的发展现状和质量。
我们分析了由医学实验室质量保证协会（INSTAND e.V.）在 7 年内作为外部质量评估计划（EQA）的一部分收集的有关欧洲 HDM、美洲 HDM 和猫上皮细胞过敏原源的数据。对 4 家主要体外诊断 sIgE 检测供应商的半定量数据和过敏原类结果进行了伪匿名比较。为了评估实验室间的可比性，确定了变异系数（CV）。
用于主要过敏原源 HDM 和猫上皮细胞的体外过敏诊断测试仍然显示出制造商依赖性的差异。尽管如此，除了 1 家供应商外，我们发现结果和实验室间可比性正在谨慎地趋同。
尽管这些结果令人鼓舞，但未来的 EQAs 必须密切监测，以确保这种积极趋势不仅仅是昙花一现。
