AOAC-RI ERP Micro June 2016

OMAMAN-29/OMAMAN-30 Combined Collaborative Study Protocol OMA ERP - June 2016 ERP Use Only

3M MDA 2 Listeria species and L. monocytogenes Collaborative Study OMA-2016-MONTH-XXX

Appendix 8.1

Instructions to Collaborators

General Instructions about Collaborative Studies Introduction

The purpose of this document is to provide detailed instructions for performing the collaborative study for the 3M MDA (MDA) 2 - Listeria and the 3M MDA 2 - Listeria monocytogenes methods. The trial will be conducted by Study Directors: Lisa Monteroso from 3M and Patrick Bird and Erin Crowley from Q Laboratories. The Study Directors are responsible for providing the test portions, clarifying procedures, collating the results, and submitting a final report to AOAC INTERNATIONAL. Should any questions arise before or during the course of the study, please direct them immediately to the attention of one of the Study Directors: Patrick Bird & Erin Crowley

Co-Study Directors Q Laboratories, Inc.

1400 Harrison Avenue Cincinnati, Ohio 45214 Phone : 513-471-1300 Fax : 513-471-5600 Email: pbird@qlaboratories.com ecrowley@qlaboratories.com

1 2

Important Information 3 4 1. Read the methods and Safety Instructions carefully. If you have any questions, contact one of 5 the Study Directors. The 3M MDA2 - Listeria and 3M MDA2 - Listeria monocytogenes Assays 6 are intended for use in a laboratory environment by professionals trained in laboratory 7 techniques. The user should read, understand and follow all safety information in the instructions 8 for the 3M Molecular Detection System and the 3M MDA2 - Listeria and 3M MDA2 - Listeria 9 monocytogenes; retain the safety instructions for future reference. The 3M MDA2 - Listeria and 10 3M MDA2 - Listeria monocytogenes method may generate Listeria monocytogenes to levels 11 sufficient to cause stillbirths and fatalities in pregnant women and the immuno compromised, if 12 exposed. The user must train its personnel in current proper testing techniques: for example, 13 Good Laboratory Practices, ISO 17025, or ISO 7218. Follow all instructions carefully. Failure to 14 do so may lead to inaccurate results. The 3M Molecular Detection Instrument is intended for use 15 with samples that have undergone heat treatment during the assay lysis step, which is designed to 16 destroy organisms present in the sample. Samples that have not been properly heat treated during 17 the assay lysis step may be considered a potential biohazard and should NOT be inserted into the 18 3M Molecular Detection System (instrument). Store the 3M MDA2 Assays at 2-8°C. Do not 19 AOAC Research Institute Expert Review Panel Use Only

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