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BACKGROUND Food allergy—particularly immunoglobulin E (IgE)-mediated food allergy—is now a global public health problem. It results in considerable morbidity, healthcare utilisation, and impairment in quality of life. Food allergy reactions range in severity from relatively mild features to life-threatening anaphylaxis. 3 Estimates of the prevalence of food allergy vary, but overall lifetime prevalence has been estimated as affecting up to 7% of children and 6% of adults. 5 Careful avoidance of offending foods is the mainstay preventive strategy for food allergy. 3 Accurate diagnosis is essential in order to provide appropriate, potentially life-saving advice on how to prevent and manage reactions. This will also help to prevent unwarranted dietary restrictions. 3 The diagnosis of food allergy is typically based on a combination of clinical history and an objective marker of allergic sensitisation, namely, skin prick tests (SPT) and/or immunoassays of serum-specific IgE levels. While these approaches have reasonable sensitivity, they have suboptimal specificity and are in general poorly predictive of the severity of reactions. Further diagnostic confirmation with a double-blinded placebo-controlled food challenge (DBPCFC)—the gold standard diagnostic test—is therefore often required. 3, 7 DBPCFC is however costly, technically challenging, time-consuming, labour-intensive, and associated with important safety risks as the procedure can trigger anaphylaxis. 3, 8 Nevertheless, although risky, DBPCFCs offer a reliable diagnosis, which in turn increases patients’ quality of life. The limitations of conventional methods for diagnosing food allergy have stimulated promising developments in molecularbased diagnostic techniques, collectively referred to as component-resolved diagnosis (CRD). 8, 10 Molecular diagnosis of food allergy involves examining the specific proteins in foods, primarily at the molecular level. In this case, rather than providing a summary of all the allergen proteins in a particular food (e.g., peanuts), molecular-based methods quantify the individual proteins within a food that may be responsible for allergic reactions. In CRD, specific IgE responses are evaluated against individual allergenic molecules or the epitopes of those allergens. Therefore, CRD techniques have the potential to enhance the specificity and sensitivity of serum-specific IgE responses to foods. They may also: facilitate our ability to determine specific food allergy phenotypes; help improve compilation of a patient-tailored risk profile to specific food allergens, given that IgE antibodies to food molecules vary from patient to patient and also geographically; and boost the ability to distinguish between primary and secondary sensitisers. 8, 10 Importantly, in CRD approaches, diagnosis can be undertaken either in single test formats or in a microarray by simultaneously evaluating a range of allergens. 8, 10 There is now a substantial body of evidence on using CRD to diagnose food allergy, which needs to be synthesised in order to generate robust estimates of diagnostic accuracy and assess costeffectiveness in comparison with conventional approaches. Furthermore, a synthesis of the underlying evidence will help to inform deliberations on whether and how CRD should be deployed for (i) diagnosing food allergy, and (ii) assessing patient risk through the prediction of food allergy severity (i.e., the likelihood of life-threatening anaphylaxis as opposed to relatively mild features) across differing healthcare service contexts.

Investigating the accuracy, risk impact, and cost-effectiveness of component-resolved diagnostic test for food allergy: a systematic review protocol