Bioassays in Allergy: Technical Characteristics, Limitations, and Pathways to Clinical Implementation—An EAACI Position Paper
Cagatay Karaaslan, Oscar Palomares, Busra Kilic, Cristobalina Mayorga, Hans Jürgen Hoffmann, Bernadette Eberlein, Edward Knol, Ruben Fernandez‐Santamaria, Joana Vitte, Elena Izquierdo, Cristina Gomez‐Casado, Marina Perez‐Gordo, Araceli Diaz Perales, Maria M. EscribeseABSTRACT
Bioassays offer functional readouts of immune responses through specific biomarkers, providing mechanistic insight beyond conventional serology. By capturing cellular activation, tissue‐level changes, and molecular signaling, they hold promise for refining allergy diagnosis, risk stratification, and treatment monitoring, contributing to precision medicine. This review summarizes the current landscape of three allergy‐relevant bioassays: basophil activation test, histology, and molecular biology‐based assays. We discuss their underlying principles, clinical utilities as well as methodological and translational challenges and translational barriers. Attention is given to unmet needs such as assay standardization, reproducibility, and integration into clinical workflows. Finally, we outline future directions for research and clinical implementation, emphasizing the potential of bioassays to refine personalized management of allergic disorders. This position paper clearly distinguishes between descriptive summaries of the available evidence and the potential applicability recommendations of the EAACI Task Force, thereby enhancing clarity and interpretability for clinicians and researchers.