Implementation of Allergen Test Methods in an ISO 17025 Accredited Laboratory

Karl Kurz¹, Daniel Langlois, Eric Marceau²

1 .Burnaby Laboratory, Canadian Food Inspection Agency, 3155 Willingdon Green, Burnaby, British Columbia, V5G 4P2
2. Longueuil Laboratory, Canadian Food Inspection Agency, 1001 rue St-Laurent Ouest, Longueuil, Québec, J4K 1C7

The main role of the Canadian Food Inspection Agency (CFIA) laboratory system is to provide laboratory testing services in support of the monitoring, surveillance and compliance activities delivered by its Programs and Operations staff. The Burnaby and Longueuil labs provide this testing service in the food allergens realm. Both labs have extensive experience performing ELISA-based analytical methods, the first method being implemented in 1994. Current capabilities include methods for peanut, egg, gluten, milk (both casein and beta-lactoglobulin based), almond, hazelnut, Brazil nut, soy and crustaceans. All CFIA laboratories are accredited under the ISO Guide 17025 standard, which rigorously specifies how a laboratory operates. Factors such as the lack of commercially available reference materials and 'universal' standards, differences in how kits report results, cross-reactivity and matrix effects pose challenges to a laboratory when validating an allergen method. Procedures, tips and tricks the laboratories use to mitigate these risks and comply with the ISO standard will be presented, including the use of proficiency testing, sample exchanges, multi-lab evaluations and matrix effect compensation. The labs' approach to estimating measurement uncertainty associated with a test kit's output will be discussed.