All Kits are Equal - But Some are More Equal than Others

Bert Popping

Director of Molecular Biology and Immunology, Eurofins Scientific Group

Allergen assays have never been used as much as in recent days. This is predominantly due to new legislation having come into force in the USA and Europe. While both, USA and Europe have the 'big eight' allergens, i.e. egg, milk, fish, shellfish, tree nuts, peanuts wheat and soya, Europe in addition requires mustard, celery, sulphite and sesame to be labelled.

Currently, allergens are routinely detected by either PCR or ELISA assays, with ELISA being the more established test method. However, many assays are not well characterised and validation is a 'must' for these assays.

Recently, several ELISA assays have undergone extensive validation, either in house or interlaboratory. Having successfully passed this validation, it appears that this does not protect the user of ELISA assays from unexpected results, due to the wide range of matrices to which the assays are applied. This poster will show several cases where ELISA produced incorrect results, and how a laboratory should handle these findings. It will give guidance how to identify problems with ELISA, and what can be done to overcome these problems.