Replacement of allergen challenge: Safely scoring prevalence & severity of allergies

Technology Description

The BAT mimics an allergic reaction in vitro. For this, a blood sample is incubated with a potential allergen, which finds a matching, basophil coupled IgE only in case of an existing allergy. However, only the IgE/allergen complex mediates cross-linking with the IgE receptor, resulting in the release of histamine, and eventually the surface-exposure of activation markers like CD63 or CD203c, which can be readily detected e.g., by flow cytometry. Considering its simplicity and accuracy, attempts have been made in the past to exploit this system for determining the presence and severity of allergies. To this end, prior-art tests either used an extract of the allergy-triggering source, or one or two specific allergens present therein, which allowed to discriminate between allergic and non-allergic individuals, but not to determine the actual allergy severity and to guide clinical treatment decisions.

The present invention overcomes these shortcomings by individually determining basophil activation and change of activation markers for at least three different stimuli of the allergy-triggering source, i.e., an extract, a major allergen, and a lipid-associated allergen. The resulting data are then used to calculate a combined symptom and tolerance class (CSTC), on which basis patients can be categorized into individuals with high tolerance and no allergy (CSTC 0), mild allergy and substantial tolerance (CSTC 1), moderate allergy and moderate tolerance (CSTC 2), and severe allergy and low to no tolerance (CSTC 3). In combination with an improved BAT system, the whole method and evaluation can be conducted in high-throughput and in a fully automated fashion.