AOAC RI ERP Final Action Recommendations eBook

Collaborative Study Approved Protocol Expert Review Panel Use Only

significantly reducing the potential for contamination with one or more molecules of amplified PCR product.

This automated BAX® System method uses fluorescent detection to analyze PCR product. One PCR primer for each target (one Salmonella- specific target and an internal control) contains a fluorescent dye (two different dyes, one for each target) as a constituent of the primer as well as a quencher (the uni- molecular combination of a primer, fluorescent dye and quencher constitute a Scorpion™ Probe). When incorporated into a PCR product, the dye and quencher are spatially separated, which causes an increase in emission signal. The BAX® System measures the magnitude and characteristics of fluorescent signal change. An analysis by the BAX® System software algorithm then evaluates that data to determine a positive or negative result which is displayed as described below.

BAX ® System Real-Time PCR Assay for Salmonella Estimated Official Start Date

It is estimated that January 14 th , 2013 will be the first week of testing. Samples will be shipped to be received on January 11 th , 2013, the Friday before testing and stored at 2-8 o C until analysis on Monday.

Study Coordination

The Study Directors are responsible for providing the test portions, clarifying procedures, collating the results, and submitting a final report to AOAC INTERNATIONAL. Should any questions arise before or during the course of the study, please direct them immediately to the attention of one of the co-Study Directors. A conference call will be schedule prior to study initiation to discuss any questions that you may have about the study design, methods and/or workflow outlined in this protocol. The co-Study Directors for this collaborative study are:

Morgan Wallace, Ph.D.

Patrick Bird

DuPont Qualicon

Q Laboratories, Inc. 1400 Harrison Avenue Cincinnati, Ohio 45214 Phone : 513-471-1300 Fax : 513-471-5600

ESL Bldg. 400 PO Box 80400

Route 141 & Henry Clay Rd.

Wilmington, DE 19880 Phone: 302-695-5473

Email: pbird@qlaboratories.com

Fax : 302-695-5877 Email: Morgan.Wallace@usa.dupont.com

Collaborative Study Design

The study will include two matrices to be tested for Salmonella species: orange juice (25 g sample size) and hot dogs (325 g sample size)

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