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3M MDA2 E. coli O157:H7 Collaborative Study
May 2016
OMA-2016-May-XXXX
DRAFT DOCUMENT
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Introduction
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The purpose of this document is to provide detailed instructions for performing the collaborative study
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for the 3M™ Molecular Detection Assay 2 -
E. coli
O157 (including H7).
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The trial will be conducted by co-Study Directors, Lisa Monteroso and TBD. The Study Directors are
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responsible for providing the test portions, clarifying procedures, collating the results, and submitting a
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final report to AOAC INTERNATIONAL. Should any questions arise before or during the course of the
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study, please direct them immediately to the attention of one of the co-Study Directors:
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Lisa Monteroso
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3M Food Safety Department
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3M Center, Bldg. 275-5W-05
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St. Paul, MN 55144-1000
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Email:
lmonteroso@mmm.com15
Phone: 651-736-2913
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Co-SD: Leslie Thompson
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Vanguard Scienes
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Sioux Falls, SD
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Important Information
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1. Read the methods carefully. If you have any questions, contact one of the co-Study Directors.
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2. It is advised to make at least one practice run before the trial using your own materials so that you
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can minimize errors in manipulations. Check that all pipettes, equipment, and 3M MDA2 -
E. coli
O157
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(including H7) supplies are on hand.
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3. Make the determination on the specified date. Store the test portions according to the instructions.
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It is essential for the validity of the trial that all collaborators commence the analysis of each test portion
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on the designated day. Immediately upon receiving each shipment, confirm the contents with the Study
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Director by faxing the form provided in the shipment.
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4. THIS IS A STUDY OF THE METHOD, NOT OF THE LABORATORY. THE METHOD MUST BE FOLLOWED AS
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CLOSELY AS PRACTICABLE, AND ANY DEVIATIONS FROM THE METHOD AS DESCRIBED, NO MATTER HOW
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TRIVIAL THEY MAY SEEM, MUST BE NOTED ON THE REPORT FORM.
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5. Report all of your results as soon as analyses are completed. Do not do more or less than indicated in
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the instructions. For example, do not do duplicate analysis and report the best or average result. More
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or fewer results complicate the statistical analyses and may invalidate your results. Data sheets are
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provided with these instructions and indicate which results are to be reported. Please include any
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criticisms, suggested improvements, or general comments about the products on the Collaborators’
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Comments Form provided. Any results that were derived from modified protocols should be included
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but must be separated from the main report. Results and comments should be returned to the Study
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Director immediately upon completion of each portion of the study.
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Information about this Collaborative Study
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OMAMAN-35 B: Collaborative Study Protocol
ERP USE ONLY
January 2017
AOAC Research Institute
Expert Review Panel Use Only