Development and Validation of Food Allergen Tests at Tecra International - Ruggedness and Market Suitability Testing

Ian Garthwaite, Josie Quindere, Uta Gasanov, Victoria Hutchison & Victoria Stitt.

TECRA International Pty Ltd., 13 Rodborough Rd, Frenchs Forest, NSW 2086 Australia.

TECRA have developed a number of assays for the detection of food allergens, including the recently released Aller-tect^TM protein swab. Additional kits are in the pipeline, with milk kits to be released shortly.

This presentation provides an overview of TECRA's pre-release validation program, which ensures product suitability and robustness. Central to the process is a well developed Product Evaluation Laboratory (PE Lab), who perform the initial validation, as well as studies required for AOAC approvals, and market support. Results will be presented with a focus on the validation of the Egg Visual Immunoassay for use with raw and cooked food.

Following development, a prototype is evaluated to ensure that the kit is consistent with product specifications. Shelf-life studies are initiated; instructions and other printed materials are prepared along with the kits. PE Lab staff then perform the role of "first user", by evaluating the performance in a pilot study which confirms the kit characteristics, including ease of use, and clarity and content of the instruction manual. As a result, any suggested improvements are actioned, and a decision is made to proceed to the first saleable manufacturing run.

The new kit is extensively tested by the PE Lab against the kit claims for sensitivity, reactivity (cross-reactions and matrix effects), reproducibility, and robustness. Upon successful completion, the kit is subjected to external beta trials, which include a minimum of two external labs. This study provides constructive feedback and determines the kit reproducibility in the hands of potential customers.

The kit is then launched to market. Following launch, the PE Lab continues to generate data to support robustness and applicability studies, as well as work with customers to develop methods for specific applications. Kit manufacture and shelf life is additionally monitored by QC personnel under ISO 9001:2000 certification of our Quality Management System.