Microsoft Word - Draft OMB Meeting Agenda-April 11 2019

OMB Meeting 4-11-2019 Pre-read Materials

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OMAMAN-31 E: AOAC RI PTM Report 091501 ERP Use Only - March 2016

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Inspect, proceed to confirmation test using your preferred method or as specified by local

regulations.

Confirmation

Presumptive positive samples of primary enrichments were confirmed by following the appropriate reference method confirmation, beginning with transfer from the primary enrichment to secondary enrichment broth (if applicable), followed by subsequent plating and confirmation

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of isolates using appropriate biochemical and serological methods.

Validation Study

The study was conducted according to the procedures outlined in the AOAC Research Institute Performance Tested Methods SM protocol: 3M ™ Molecular Detection Assay 2 - Salmonella (March 23, 2015: Revised April 10, 2015) [5] . The MDA2 - Salmonella method was compared to the following reference methods: the USDA/FSIS MLG 4.08 method for raw ground beef (73% lean), raw ground chicken, chicken carcass rinse, chicken carcass sponge, pasteurized liquid whole egg, and cooked breaded chicken; the FDA/BAM Chapter 5 method for instant non-fat dry milk, black pepper, cocoa powder, raw bagged spinach, raw whole shrimp, creamy peanut butter, dry dog food, pasteurized processed American cheese;, sealed concrete, stainless steel, and sealed ceramic tile environmental surfaces, the FDA Guidance for Industry method [3] for the evaluation of spent sprout irrigation water. The validation consisted of an inclusivity/exclusivity study, a method comparison study, a stability (lot to lot) study, and a robustness study. All data was analyzed using the Molecular Detection System software. One hundred and eleven (111) frozen Salmonella strain suspensions were thawed and sub- cultured in brain heart infusion (BHI) broth overnight at 37°C ± 1°C. The cultures were diluted in peptone salt solution in order to inoculate between 10 to 100 cells per 225 mL of 3M BPW ISO. The enrichment broths were incubated for 24 hours at 37°C ± 1°C and 41.5°C ± 1°C, and Thirty frozen non- Salmonella strain suspensions were thawed and sub-cultured in BHI broth overnight at 37°C ± 1°C. The cultures were diluted in buffered peptone water (BPW) in order to inoculate 10 5 CFU/mL. The broths were then incubated for 24 hours at the appropriate incubation temperature in order to have culture to test with the 3M MDA2 – Salmonella method. Of the 111 Salmonella strains evaluated, 109 target strains were directly detected without additional testing. Two strains showed specific temperature requirements for the enrichment step, but gave all positive 3M TM MDA2 - Salmonella tests. Salmonella Poona CIP 107125 gave positive results when grown at 37°C, but not at 41.5°C. Another Salmonella Poona strain was tested (Ad 2330) and gave a positive test at both incubation conditions. Salmonella Urbana Ad 501 gave positive results when grown at 37°C, but not at 41.5°C; a second strain was tested the 3M MDA2 - Salmonella method was then performed. Results AOAC Research Institute Expert Review Panel Use Only Inclusivity and Exclusivity Methodology

04/05/2019