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3M MDA 2
Listeria
species and
L. monocytogenes
Collaborative Study
OMA-2016-MONTH-XXX
5/4/16
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.com1
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
OMAMAN-29/OMAMAN-30 Combined Collaborative Study Protocol
OMA ERP - June 2016
ERP Use Only