Food Allergy Without a Safety Net—Molecular Sensitisation Patterns and Family Quality of Life Among Bulgarian Children in a Setting Without Epinephrine Auto-Injectors

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Abstract
Pediatric food allergy is an increasing public health challenge associated with severe allergic reactions, psychosocial burden, and healthcare inequalities. This study aimed to characterise molecular sensitisation patterns among Bulgarian children with suspected food allergy using component-resolved diagnostics and to evaluate family quality of life in a healthcare setting without access to epinephrine auto-injectors. A total of 1163 pediatric patients underwent molecular allergy testing using the ALEX2 multiplex platform, while 90 caregivers completed structured quality-of-life questionnaires. A sensitisation threshold of >0.10 kUA/L was applied to maximise sensitivity for molecular profiling and co-sensitisation analyses. Tree nut allergens showed the highest sensitisation prevalence, predominantly involving Ana o 3, Pis v 1, Jug r 1, Cor a 9, and Cor a 14. Younger children showed a predominance of stable storage protein sensitisation, whereas older children more frequently demonstrated PR-10-associated cross-reactive profiles. Correlation analyses identified strong co-sensitisation clustering among phylogenetically related allergen families, particularly cashew-pistachio, walnut-hazelnut, mammalian milk, and fish allergens. Questionnaire responses revealed substantial psychosocial burden related to fear of anaphylaxis, chronic hypervigilance, restricted daily activities, and inadequate emergency preparedness. These findings highlight the importance of molecular risk stratification and underscore major unmet needs in pediatric food allergy management in Bulgaria.

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