Validation Study to Demonstrate the Equivalence of a Minor Modification (TECRA® ULTIMA™ Protocol) to AOAC Method 998.09 (TECRA® Salmonella Visual Immunoassay) with the Cultural Reference Method

Author： Briggs Julie Dailianis Angela Hughes Denise Garthwaite Ian

Publisher： AOAC International

ISSN： 1944-7922

Source： Journal of AOAC International, Vol.87, Iss.2, 2004-03, pp. : 374-379

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Abstract

The TECRA® Salmonella Visual Immunoassay (VIA™) using Rappaport-Vassiliadis RV[R10] as a single selective enrichment broth has Final Action approval (AOAC Method 998.09). TECRA has recently developed a protocol (TECRA ULTIMA), which involves the addition of a new additive to a 1 mL aliquot of the RV[R10] broth, prior to the heat-killing step, thereby allowing the RV[R10] broth to be tested directly in the kit and thus eliminating the need for the 2 h post-enrichment in M broth. An in-house validation study was conducted to compare the modified AOAC Method 998.09 to the reference culture method. Three foods were used in the study: Naturally contaminated raw ground poultry at high (10–50 cells/25 g), and low (1–5 cells/25 g) levels; and milk powder and peanut butter, artificially inoculated at low and high levels with Salmonella bovismorbificans and S. enterica Mbandaka, respectively. Twenty test portions were analyzed for each level with 10 uninoculated control samples per food. Overall, no significant differences (p < 0.05) were observed when the proportion of positive test portions for the modified VIA were compared with that for the reference method. This minor modification, which employs the additive (provided in the TECRA ULTIMA SALMONELLA Test Kit) to permit the direct analysis of RV[R10] broth has demonstrated the utility of the TECRA ULTIMA SALMONELLA protocol. It is recommended that the minor modification to Method 998.09 be approved First Action as an additional option within the method.