AOAC-RI ERP Book Micro Jan 19 2017

OMAMAN-35 B: Collaborative Study Protocol ERP USE ONLY January 2017

3M MDA2 E. coli O157:H7 Collaborative Study

May 2016

OMA-2016-May-XXXX

Introduction 1 2 The purpose of this document is to provide detailed instructions for performing the collaborative study 3 for the 3M™ Molecular Detection Assay 2 - E. coli O157 (including H7). 4 5 The trial will be conducted by co-Study Directors, Lisa Monteroso and TBD. The Study Directors are 6 responsible for providing the test portions, clarifying procedures, collating the results, and submitting a 7 final report to AOAC INTERNATIONAL. Should any questions arise before or during the course of the 8 study, please direct them immediately to the attention of one of the co-Study Directors: 9 10 Lisa Monteroso 11 3M Food Safety Department 12 3M Center, Bldg. 275-5W-05 13 St. Paul, MN 55144-1000 14 Email: lmonteroso@mmm.com 15 Phone: 651-736-2913 Important Information 22 23 1. Read the methods carefully. If you have any questions, contact one of the co-Study Directors. 24 25 2. It is advised to make at least one practice run before the trial using your own materials so that you 26 can minimize errors in manipulations. Check that all pipettes, equipment, and 3M MDA2 - E. coli O157 27 (including H7) supplies are on hand. 28 29 3. Make the determination on the specified date. Store the test portions according to the instructions. 30 It is essential for the validity of the trial that all collaborators commence the analysis of each test portion 31 on the designated day. Immediately upon receiving each shipment, confirm the contents with the Study 32 Director by faxing the form provided in the shipment. 33 34 4. THIS IS A STUDY OF THE METHOD, NOT OF THE LABORATORY. THE METHOD MUST BE FOLLOWED AS 35 CLOSELY AS PRACTICABLE, AND ANY DEVIATIONS FROM THE METHOD AS DESCRIBED, NO MATTER HOW 36 TRIVIAL THEY MAY SEEM, MUST BE NOTED ON THE REPORT FORM. 37 38 5. Report all of your results as soon as analyses are completed. Do not do more or less than indicated in 39 the instructions. For example, do not do duplicate analysis and report the best or average result. More 40 or fewer results complicate the statistical analyses and may invalidate your results. Data sheets are 41 provided with these instructions and indicate which results are to be reported. Please include any 42 criticisms, suggested improvements, or general comments about the products on the Collaborators’ 43 Comments Form provided. Any results that were derived from modified protocols should be included 44 but must be separated from the main report. Results and comments should be returned to the Study 45 Director immediately upon completion of each portion of the study. AOAC Research Institute Expert Review Panel Use Only 16 17 18 19 20 21 Co-SD: Leslie Thompson Vanguard Scienes Sioux Falls, SD

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Information about this Collaborative Study

DRAFT DOCUMENT

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