Basophil activation test: mechanisms and considerations for use in
clinical trials and clinical practice
Abstract
The basophil activation test (BAT) is a functional assay that measures
the degree of degranulation following stimulation with allergen or
controls by flow cytometry and is directly correlated with histamine
release. From the bell-shaped curve resulting from BAT in allergic
patients, basophil reactivity (given by %CD63+ basophils) and basophil
sensitivity (given by EC50 or similar) are the main outcomes of the
test. BAT takes into account all characteristics of IgE and allergen and
thus can be more specific than sensitization tests in the diagnosis of
allergic disease. BAT reduces the need for in vivo procedures, such as
intradermal tests and allergen challenges, which can cause allergic
reactions of unpredictable severity. As it closely reflects the
patients’ phenotype, it can potentially be used to monitor the natural
resolution of food allergies and to predict and monitor clinical
response to immunomodulatory treatments, such as allergen-specific
immunotherapy and biologicals. Clinical application of BAT requires
analytical validation, clinical validation, standardization of
procedures and quality assurance to ensure reproducibility and
reliability of results. Currently, efforts are ongoing to establish a
platform that could be used by laboratories in Europe and in the USA for
certification.