The BAT II Study is a cross-sectional diagnostic study in which children with suspected IgE-mediated allergy to foods (namely cow's milk, egg, sesame and cashew), as defined by a history of an immediate-type allergic reaction to a food or no history of food consumption or the presence of food-specific IgE as documented by skin prick test or serum specific IgE, will undergo a diagnostic work-up to confirm or refute the diagnosis of IgE-mediated food allergy. Participants will be prospectively recruited from specialised Paediatric Allergy clinics in London and will undergo skin prick testing (SPT), specific IgE testing to allergen extracts and allergen components, basophil activation test (BAT) and oral food challenge. The diagnostic accuracy of the BAT and of other allergy tests will be assessed against the clinical gold-standard.
Study Type
OBSERVATIONAL
Enrollment
600
Patients with suspected food allergy will undergo clinical and dietary assessments and oral food challenge. Different allergy tests will be performed, including skin prick test, specific IgE test and basophil activation test, and its diagnostic utility will be determined against the clinical gold-standard.
Pediatric Allergy Clinical Research Facility, Evelina Children's Hospital
London, United Kingdom
RECRUITINGDiagnostic accuracy of the basophil activation test (for each individual food allergy)
Accuracy of %CD63+ basophils
Time frame: 3 years
Diagnostic accuracy of SPT, specific IgE to extracts and to single allergens
Accuracy of weal diameter or level of IgE
Time frame: 3 years
Association between BAT and severity of symptoms during challenges
Correlation between %CD63+ basophils and severity grade
Time frame: 3 years
Association between BAT and threshold of reactivity during challenges
Correlation between CD-sens and cumulative threshold dose
Time frame: 3 years
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