Food allergy: A clinician’s criteria for including sera in a serum bank
Introduction
New processing technologies for established foods and introduction of genetically-modified foods are changing the nature of our diet. Because of this, potentially allergic individuals are increasingly exposed to novel foods and proteins. The possible risk of allergenic responses to foods or proteins derived from genetically-modified crops is therefore a significant public health concern. Regulatory agencies recommend that genetically-modified foods undergo allergy assessment, including tests for IgE binding against sera from allergic subjects. This approach will identify food proteins that share significant amino acid sequence identity with known allergens (Taylor, 2006). Guidelines for assessment of allergenicity of GM crops have been published in three documents: the first comprehensive document was published by the international food biotechnology council (IFBC) in collaboration with the ILSI Allergy and Immunology Institute (Metcalfe et al., 1996); then, in 2001, the FAO/WHO published allergen testing recommendations (FAO/WHO, 2001) and in 2003, the Codex Alimentarius Commission guidelines were published (FAO/WHO, 2003). All three documents indicate that the primary risk is to individuals with existing allergies to known allergens. Thus, novel foods should avoid introduction of known allergens into the food supply.
Sera from patients with well-defined food allergies will be helpful for assessing the allergenicity of novel proteins. Which sera, however, should be included in serum banks for such testing? The aim of this article is to define from a clinician’s point of view the criteria for using a serum to test allergenicity of novel proteins, and for including that serum in a serum bank.
Section snippets
Clinical manifestations of food allergy
Food allergy affects up to 8% of children and 2–5% of adults (Osterballe et al., 2005, Zuberbier et al., 2004). However, the prevalence of food allergy in the general population is overestimated, because food allergy is often associated with chronic and/or idiopathic symptoms and diseases, including chronic fatigue syndrome, irritable bowel syndrome, headache and psychological disorders. In contrast, clinical food allergy is a well-defined disease that involves clearly-defined clinical
Clinical diagnosis of food allergy
The first step in diagnosing food allergy is a detailed case history. This information is used to triage patients according to whether they are likely or unlikely allergic subjects. Information on concurrent respiratory allergies, in particular, to pollen, but also latex or house dust mites should be included in the case history.
Food-specific IgE antibodies can be assessed by in vitro assay or a skin prick test (SPT); these tests attempt to link the clinical symptoms with an IgE-mediated
Clinical tests for routine diagnosis of food allergy
The skin prick test (SPT) and in vitro assay for food-specific IgE are currently the primary tools for diagnosing food allergy (Sampson, 1999). While the SPT is inexpensive and rapid, its outcome is influenced by a variety of factors that are difficult to standardize. These include the source of the allergen, the use of commercially available food extracts versus the use of native foods for skin testing, the condition of the patient’s skin, prick technique and patient’s health and/or
Oral challenge test
Case history, SPT and in vitro IgE tests, are often not sufficient to discriminate between allergic and sensitized subjects. In many children with atopic dermatitis, <50% of reported food allergies could be substantiated by DBPCFC (Sampson and Ho, 1997). These findings underscore the need to substantiate case histories of food allergy with a DBPCFC. The DBPCFC is the only allergy test that controls for co-morbidity with other chronic disorders (i.e., chronic urticaria, atopic dermatitis),
Special considerations
Because children <3 years of age often “outgrow” an allergy to egg, milk and wheat proteins (Bock and Atkins., 1990, Bock, 1982, Saarinen et al., 2005, Boyano-Martinez et al., 2002), testing of blood samples from young allergic children for more than six months after a positive food challenge is not advised. Food allergy is more likely to persist in children who develop food sensitivity after three years of age (Burks and Ballmer-Weber, 2006). For these children, serum sampling should be
Conclusions
The minimal criteria for a patient’s serum to be included in a serum bank are: (1) The patient’s case history should provide evidence of immediate-type food allergy accompanied by classical symptoms of type I allergy; and (2) a positive SPT or evidence of elevated food-specific IgE in the serum. Even if these criteria are met, some sera included in the serum bank may be from sensitized patients who do not demonstrate clinical food allergy. In addition, sera from some patients with clinical food
Conflicts of interest statement
The authors declare that there are no conflicts of interest.
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