AOAC RI ERP Final Action Recommendations eBook

Collaborative Study Approved Protocol Expert Review Panel Use Only

2. Report data on data report form labeled “ BAX ® System Collaborative Study Test portion Data Report Form” for all test portions.

3. Upon completion of analysis of each food type, the laboratory will fax or email the completed data form result sheets to Patrick Bird at: (513)-471-5600 or pbird@qlaboratories.com

Important Information

1. Read the methods carefully. If you have any questions, contact one of the co-Study Directors.

2. It is advised to make at least one practice run before the trial using your own materials so that you can minimize errors in manipulations. Check that all pipets, equipment, and BAX ® System supplies are on hand. 3. Make the determination during the specified time. Store the test portions according to the instructions. It is essential for the validity of the trial that all collaborators commence the analysis of each test portion on the MONDAY of each week. Immediately upon receiving each shipment, confirm the contents with the Study Director by faxing the form provided in the shipment. 4. THIS IS A STUDY OF THE METHOD, NOT OF THE LABORATORY. THE METHOD MUST BE FOLLOWED AS CLOSELY AS PRACTICABLE, AND ANY DEVIATIONS FROM THE METHOD AS DESCRIBED, NO MATTER HOW TRIVIAL THEY MAY SEEM, MUST BE NOTED ON THE REPORT FORM. 5. Report all of your results as soon as analyses are completed. Do not do more or less than indicated in the instructions. For example, do not do duplicate analysis and report the best or average result. More or fewer results complicate the statistical analyses and may invalidate your results. Data sheets are provided with these instructions and indicate which results are to be reported. Upon completion of the study, collaborators are encouraged to complete the “ BAX ® System Collaborative Study Collaborator Comments Form” in Appendix 10.4. Any comments regarding study design or the BAX ® System method are encouraged to allow the Study Sponsor to fully understand the needs of the end user. Any results that were derived from modified protocols should be included but must be separated from the main report. Results and comments should be returned to the Study Director immediately upon completion of each portion of the study. 6. See safety precautions in the BAX ® System Real-Time PCR Assay for Salmonella package inserts (refer to the following sections in the package insert: Warnings and Precautions and Waste Disposal). The proprietary test kit is testing for the enumeration of Salmonella , which could include potentially pathogenic organisms. Although the test kit itself does not contain any pathogenic components, the inoculated test strip may contain the target organism. Therefore,

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