HULAFE is a large tertiary-care academic hospital with extensive expertise in the management of drug-allergic patients including conventional in vivo and in vitro tests as well as the performance of the new ex vivo challenges by the basophil activation test. They will provide support in identifying new allergen components, purifying human IgEs, and validating the final methodology for determining drug allergy in humans. Both hospitals are responsible for: the supply of serum samples from well identified drug-allergic patients as optimization sets; their clinical evaluation; the statistical analysis of allergy profiling; the revision of patient management protocols; and data storage and exploitation.
• WP3: HULAFE will be in charge in the coordination of WP3 sample selection, compounds synthesis and development. HULAFE will be mainly devoted to
i. Identification of well-characterized beta-lactam allergy patients
ii. Obtaining serum samples from beta-lactam allergic patients
iii. Selection of the implicated molecules, recognized by the specific IgE from allergic patients
iv. Purification of IgEs from allergic patients
v. Evaluation of the known molecules, and
vi. Investigation of new ones in order to provide the highest sensitivity.
• WP5: The participation of HULAFE will consist in the evaluation of the final device in a pre-industrial trial assessing its sensitivity, specificity, positive and negative predictive values in the diagnosis of IgE-mediated beta-lactam allergy. HULAFE will:
i. Provide serum samples from beta-lactam allergic patients
ii. Evaluate the performance of the final device in the diagnosis of the selected cases of beta-lactam allergy patients
iii. Evaluate the different patterns of beta-lactam IgE recognition depending of the type of allergic manifestations and time past since the allergic reaction.
iv. Contribute to assay methodology development to optimize its use in diverse clinical settings.
• HULAFE will participate in WP6 Exploitation and Dissemination.
• WP7 HULAFE will take part in project management activities