VITEK MS Collaborative Study Outline - eBook

VITEK MS Collaborative Study

June 2019

Appendices Appendix 8.1

Instructions to Collaborators VITEK MS Microbial Identification System Workflow Collaborative Study

General Instructions about Collaborative Studies Introduction The purpose of this document is to provide detailed instructions for performing the collaborative study for the VITEK MS Microbial Identification System. The study will be conducted by co-Study Directors Ron Johnson and John Mills. The Study Directors are responsible for providing method-specific training, providing test portions, providing select supplies as outlined in Appendix 8.3, clarifying procedures, collating results, and submitting a report to AOAC INTERNATIONAL. Should any questions arise before or during the course of the study, please direct them immediately to one of the co-Study Directors: Ron Johnson and John Mills bioMérieux, Inc. 595 Anglum Road, Hazelwood, MO, 63042 Email: ron.johnson@biomerieux.com ; john.mills@biomerieux.com Phone: 314-452-3241 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 to make sure all supplies are on hand. 3. Begin the analyses on the specified date. Store the strains at refrigerated temperatures. It is essential for the validity of the trial that all collaborators commence the analysis on the designated day. Immediately upon receiving the shipment, confirm the contents with the Study Director by faxing or emailing 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 analyses 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 instructions and indicate which results to report. A space is provided on the Data Report Form to indicate any deviations to the methods or the instructions to collaborators. Please include any criticisms, suggested improvements, or general comments about the products on

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