title: The utility of an international sera bank for use in evaluating the potential human allergenicity of novel proteins.
abstract: In the safety assessment of novel foods produced through biotechnology, careful consideration is given to determining the allergenic potential of newly introduced proteins. IgE serum screening is one tool for evaluating whether the protein in question has sequence identity to a known allergen or if the source of the gene encoding the protein is a known allergenic food. A "specific" serum screen involves testing a gene product with sera from patients with documented clinical allergy to a specific allergen to confirm that the gene product of interest is not the same protein to which the patient produces IgE antibodies. A "targeted" serum screen involves testing the gene product of interest with sera from patients sensitive to food or aeroallergens from the same broad group. The concept of a global sera bank with accessible, well-characterized sera for use in such assays is an appealing option. This paper summarizes the consensus elements from a workshop to evaluate the potential utility of an international sera bank for evaluating the allergenicity of novel proteins. Areas of agreement following the workshop included the following: (1) specific sera screens are appropriate for exploring potentially cross-reactive proteins that have been identified through bioinformatics analyses; however, additional validation is needed, particularly for targeted sera screens, (2) practical and ethical considerations may preclude the formation of a global sera bank, and therefore, (3) a regional network of clinicians who could serve as sources of patient sera or be approached to conduct sera studies would be the most practical alternative.
authors.affiliation: International Life Sciences Institute Health and Environmental Sciences Institute, Washington, District of Columbia 20005, USA. kthomas@ilsi.org
authors.forename: Karluss
authors.initials: K
authors.lastname: Thomas
authors.forename: Gary
authors.initials: G
authors.lastname: Bannon
authors.forename: Corinne
authors.initials: C
authors.lastname: Herouet-Guicheney
authors.forename: Gregory
authors.initials: G
authors.lastname: Ladics
authors.forename: Laurie
authors.initials: L
authors.lastname: Lee
authors.forename: Sang-Il
authors.initials: SI
authors.lastname: Lee
authors.forename: Laura
authors.initials: L
authors.lastname: Privalle
authors.forename: Barbara
authors.initials: B
authors.lastname: Ballmer-Weber
authors.forename: Stefan
authors.initials: S
authors.lastname: Vieths
mesh_terms: D000485:Allergens / Q000235:genetics; D000937:Antigen-Antibody Reactions; D001771:Blood Banks / Q000458:organization & administration; D003429:Cross Reactions; D004044:Dietary Proteins / Q000276:immunology*; D005512:Food Hypersensitivity / Q000175:diagnosis* / Q000209:etiology / Q000276:immunology; D030841:Food, Genetically Modified / Q000009:adverse effects*; D006801:Humans; D007106:Immune Sera; D007118:Immunoassay / Q000379:methods; D007073:Immunoglobulin E / Q000097:blood; D007391:International Cooperation; D011994:Recombinant Proteins / Q000276:immunology; D015203:Reproducibility of Results
chemical_list: D000485:Allergens; D004044:Dietary Proteins; D007106:Immune Sera; D011994:Recombinant Proteins; D007073:Immunoglobulin E