Comparative Validation Study to Demonstrate the Equivalence of an Alternate Next-Day Enrichment Protocol for the TRANSIA PLATE Gold Method to Culture Methods for the Detection of in Selected Foods and Environmental Surfaces.

TRANSIA PLATE Gold is an ELISA that was validated by Association Française de Normalisation (AFNOR) in 2001 and as a (PTM) by AOAC in 2006 (PTM No. 010602) as a two-step enrichment protocol requiring 48 h. A simple next-day enrichment protocol using modified Enterohemorrhagic media was developed for the TRANSIA PLATE Gold to improve the time-to-results and laboratory work flow. We tested 128 strains, representing all serotypes from A though Z and 51-66. TRANSIA PLATE Gold detected all 128 of these strains. None of the 50 non- strains were detected by TRANSIA PLATE Gold. Performance of TRANSIA PLATE Gold using the new enrichment protocol was compared with U.S. Department of Agriculture reference culture procedure for the detection of Salmonella in ready-to-eat poultry, ready-to-eat beef, and chicken carcass rinsate. In addition, TRANSIA PLATE Gold performance was compared with U.S. Food and Drug Administration (FDA) (BAM) for the detection of from raw spinach, raw almonds, raw pasta, and environmental surfaces (stainless steel, rubber, and plastic). There was no statistically significant difference in the numbers of positive results TRANSIA PLATE Gold protocol compared with the appropriate U.S. Department of Agriculture Food Safety and Inspection Service or FDA-BAM reference methods for any of these matrixes. Robustness testing demonstrated that the introduction of small changes in the normal assay parameters had no impact on the method performance. This new enrichment protocol has been approved as a Third Level modification to 010602.