Microbiology Methods for ERP Review 3-2020

69

GENE ‐ UP ® SLM 2 Collaborative Study

July 2019

Appendix 8.1  ‐  Instructions to Collaborators

1 2 3 4

General Instructions about Collaborative Studies

Introduction 5 6 The purpose of this document is to provide detailed instructions for performing the collaborative study 7 for the GENE ‐ UP Salmonella 2 (SLM 2) method. 8 9 The trial will be conducted by co ‐ Study Directors, Ron Johnson and John Mills. The Study Directors are 10 responsible for providing the test portions, clarifying procedures, providing select materials as outlined 11 in Appendix 8.3, collating the results, and submitting a final report to AOAC INTERNATIONAL. Should 12 any questions arise before or during the course of the study, please direct them immediately to the 13 attention of one of the co ‐ Study Directors:

14 15 16 17 18 19 20

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 21 22 1. Read the methods carefully. If you have any questions, contact one of the co ‐ Study Directors. 23 24 2. It is advised to make at least one practice run before the trial using your own materials so that you 25 can minimize errors in manipulations. Check that all pipettes, equipment, and GENE ‐ UP SLM materials 26 are on hand. 27 28 3. Make the determination on the specified date. Store the test portions according to the instructions. 29 It is essential for the validity of the trial that all collaborators commence the analysis of each test portion 30 on the designated day. Immediately upon receiving each shipment, confirm the contents with the Study 31 Director by faxing or emailing the receipt form provided in the shipment. 32 33 4. THIS IS A STUDY OF THE METHOD, NOT OF THE LABORATORY. THE METHOD MUST BE FOLLOWED AS 34 CLOSELY AS PRACTICABLE, AND ANY DEVIATIONS FROM THE METHOD AS DESCRIBED, NO MATTER HOW 35 TRIVIAL THEY MAY SEEM, MUST BE NOTED ON THE REPORT FORM. 36 37 5. Report all of your results as soon as analyses are completed. Do not do more or less than indicated in 38 the instructions. For example, do not do duplicate analysis and report the best or average result. More 39 or fewer results complicate the statistical analyses and may invalidate your results. Data sheets are 40 provided with these instructions and indicate which results are to be reported. Please include any 41 criticisms, suggested improvements, or general comments about the products on the Collaborators’ 42 Comments Form provided. Any results that were derived from modified protocols should be included 43 but must be separated from the main report. Results and comments should be returned to the Study 44 Director immediately upon completion of each portion of the study.

45 46 47

14