Allergen immunoassays--considerations for use of naturally incurred standards.

The enzyme-linked immunosorbent assay (ELISA) offers many advantages for the detection of potentially hazardous allergenic food residues that might become adventitious components of other foods during the course of food production and processing. ELISAs detect proteins, and food allergens are proteins. ELISAs are sufficiently sensitive and specific for detection of food allergen residues. ELISAs can also be produced in formats that are compatible with the industrial food processing environment. However, ELISAs also have disadvantages that should be carefully evaluated and widely recognized. Various food-processing operations can have profound effects on the detectability of allergenic food residues. ELISAs detect intact proteins but protein hydrolysates evade detection in some ELISA formats. The residual proteins present in some ingredients derived from commonly allergenic sources may also not be easily detected with ELISAs because of the nature of the protein residues remaining, e.g. lipophilic. Processing operations can dramatically lower the solubility of proteins. In some food formulations, heat processing, in particular, induces chemical modifications that can affect antibody binding to epitopes in the ELISA. The use of naturally incurred standards where allergenic food residues are incorporated into various representative food matrices and then processed in a manner similar to "real-world" food processing can reveal some of the limitations of allergen ELISAs. Methods for the preparation of naturally incurred standards in chocolate, cookie, muffin, ice cream, pasta, frankfurter, and cream of potato soup are provided as examples.