Bert Popping, Molecular Biology and Immunology, Eurofins, 69a Kilnwick Road, Yorkshire, Pocklington YO42 2JY, United Kingdom, Fax +44 870 168 8047, e-mail firstname.lastname@example.org
The Science of Gluten-Free Foods and Beverages
Allergen assays have never been used as much as they have been recently. This is predominantly due to new legislation that has come into force in the United States and Europe. While both the United States and Europe have the “big eight” allergens (eggs, milk, fish, shellfish, tree nuts, peanuts, wheat, and soya), Europe additionally requires mustard, celery, sulphite, sesame, and shortly, mollusks and lupine to be labelled. Currently, allergens are routinely detected by either polymerase chain reaction (PCR) or enzyme-linked immunosorbent assays (ELISA), with ELISA being the more established test method. In order to enforce the regulation, assays for detecting allergens need to be reliable and robust. A first step is a validation exercise, e.g., AOAC Performance Tested Methods (PTM) or Official Methods of Analysis (OMA) validation. While this is very important towards gaining insight into validation-relevant parameters, it is impossible to mimic all possible matrices in such a study. Therefore, the data generated by the routine user community will give in-depth information about which matrices may not be suited for such a test and which ones are. This chapter will look at standardisation and validation approaches for allergen detection, discuss the challenges for enforcement, and present ideas on how to handle such issues and problems in the future.