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g and 375 g) and chicken carcass rinse (USDA-FSIS MLG); cream cheese, fresh bagged lettuce,

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and stainless steel (FDA BAM); and raw ground beef, dry pet food (375 g), and stainless steel (HC

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CAM). Inclusivity testing demonstrated that the BAX method was reactive with 317

Salmonella

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isolates, representing over 100 different serotypes. The BAX method did not detect 37 different

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non-

Salmonella

strains tested.

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Following the completion of the PTM study, an additional 17 matrices (15 foods/beverages and

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2 environmental surfaces) were evaluated in a pre-collaborative study. Orange juice, frozen

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peas, peanut butter, shell eggs, shrimp, white pepper, and infant formula were compared to the

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FDA BAM method; ice cream, nonfat dry milk, and cocoa were compared to both the FDA BAM

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and HC CAM methods; hot dogs, beef trim, ground beef with soy, and ground turkey were

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compared to the USDA-FSIS MLG method and HC CAM methods. Environmental surfaces

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(ceramic tile and plastic) were compared to both the FDA BAM and the USDA-FSIS MLG

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methods. Method comparison data is presented in Appendix 10.1. Results obtained using the

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BAX® System Real Time

Salmonella

test kit indicate no statistical difference when compared to

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the corresponding reference method results. A full pre-collaborative study manuscript is

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currently being drafted.

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1.3

Study Directors

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Morgan Wallace, Ph.D.

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DuPont Qualicon

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ESL Building 400

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PO Box 80400

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Route 141 & Henry Clay Road

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Wilmington, Delaware 19880

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Phone: 302.695.5473

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Fax: 302.695.5877

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Email

: Morgan.Wallace@usa.dupont.com

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Patrick Bird

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Q Laboratories, Inc.

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1400 Harrison Avenue

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Cincinnati, Ohio 45214

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513-471-1300 ext. 259

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Email

: pbird@qlaboratories.com

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2.0

Collaborators

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At least 13 laboratories will be solicited to participate in this study. A minimum of 10 valid laboratory

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data sets per matrix are required to successfully complete the study. Each collaborator will receive

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Collaborative Study Approved Protocol

Expert Review Panel Use Only