Augustin Steffen, Eichhorn Thomas, Wald Martin, Fischer Frank, Jutel Marek, Pfaar Oliver, Willers Christoph
Allergopharma GmbH & Co, Reinbek, Germany.
Merck KGaA, Darmstadt, Germany.
Allergy. 2024 Dec;79(12):3489-3500. doi: 10.1111/all.16339. Epub 2024 Oct 24.
Natural allergen sources contain a variety of allergens, against which allergic subjects have developed individual sensitization profiles. Ideal allergen products for skin prick testing (SPT) and allergen immunotherapy (AIT) should contain the complete set of allergens of the respective allergen sources to cover all sensitization profiles. However, commercially available allergen products were shown to vary regarding their allergen composition.
The qualitative allergen composition of different SPT and AIT products produced from pollen of grasses, birch, mugwort and from house dust mites was assessed by a consistent high-resolution liquid chromatography-coupled tandem mass spectrometry method (LC-MS/MS).
All major, mid-tier and most minor allergens were detected in each of the investigated three batches of SPT and AIT products, demonstrating the completeness of the allergen composition and a high degree of batch-to-batch consistency.
This is the first study using a single consistent high-resolution LC-MS/MS method to provide solid data on the qualitative allergen composition of SPT and AIT products manufactured from various common allergen sources. The applied method showed high reliability in qualitative batch-to-batch consistency testing and can be performed fast and with high throughput. High-resolution LC-MS/MS is applicable for process development and quality control to ensure market availability of allergen products corresponding to the composition of the respective natural allergen sources.
天然过敏原来源包含多种过敏原，过敏个体针对这些过敏原形成了各自的致敏谱。用于皮肤点刺试验（SPT）和过敏原免疫疗法（AIT）的理想过敏原产品应包含相应过敏原来源的全套过敏原，以涵盖所有致敏谱。然而，市售过敏原产品的过敏原组成存在差异。
采用一致的高分辨率液相色谱 - 串联质谱法（LC-MS/MS）评估由草、桦树、艾蒿花粉和屋尘螨制成的不同SPT和AIT产品的定性过敏原组成。
在每一批次所研究的三种SPT和AIT产品中均检测到了所有主要、中等和大多数次要过敏原，证明了过敏原组成的完整性以及批次间的高度一致性。
这是第一项使用单一一致的高分辨率LC-MS/MS方法来提供关于由各种常见过敏原来源制成的SPT和AIT产品定性过敏原组成可靠数据的研究。所应用的方法在批次间定性一致性测试中显示出高可靠性，并且可以快速且高通量地进行。高分辨率LC-MS/MS适用于工艺开发和质量控制，以确保与相应天然过敏原来源组成相对应的过敏原产品的市场供应。
