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VIDAS LMX & LPT Collaborative Study
April 19, 2013
OMA-2013-Apr-XXX
Appendix 9.1
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Instructions to Collaborators
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General Instructions about Collaborative Studies
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Introduction
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The purpose of this document is to provide detailed instructions for performing the collaborative
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study for the bioMérieux VIDAS
L. monocytogenes
Xpress (LMX) and VIDAS UP LPT
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methods.
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The trial will be conducted by co-Study Directors, Ron Johnson and TBD. The Study Directors
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are responsible for providing the test portions, clarifying procedures, collating the results, and
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submitting a final report to AOAC INTERNATIONAL. Should any questions arise before or
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during the course of the study, please direct them immediately to the attention of one of the co-
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Study Directors:
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Ron Johnson
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bioMérieux, Inc.
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595 Anglum Road
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Hazelwood, Missouri 63042
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Phone: 314-506-8182
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Fax: 314-731-8678
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Email:
ron.johnson@na.biomerieux.com25
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Co-SD: TBD
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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
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you can minimize errors in manipulations. Check that all pipettes, equipment, and VIDAS
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supplies are on hand.
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3. Make the determination on the specified date. Store the test portions according to the
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instructions. It is essential for the validity of the trial that all collaborators commence the
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analysis of each test portion on the designated day. Immediately upon receiving each shipment,
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confirm the contents with the Study 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
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MUST BE FOLLOWED AS CLOSELY AS PRACTICABLE, AND ANY DEVIATIONS
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FROM THE METHOD AS DESCRIBED, NO MATTER HOW TRIVIAL THEY MAY SEEM,
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MUST BE NOTED ON THE REPORT FORM.
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DRAFT DOCUMENT
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