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QIAGEN
mericon
STEC Workflow Collaborative Study Protocol
May 2016
DRAFT
2
3.4
Collaborators will each receive1test portion set as described in Table 2. All test portions
within a set will be randomized and blind coded so that the collaborators do not know
which test portions are from which contamination level. The randomization will be
different for each collaborator. In addition, collaborators will receive 1 portion of
ground beef for aerobic plate count.
Table 2. Test portion set for each collaborator
Matrix
Test Portion
Size
Number of
Test Portions
Number per
Level
Method(s)
Ground
beef
325
36
12 uninoc.
12 low
12 high
mericon
and MLG
5.09 (Paired)
3.5
Study schedule
3.5.1
All media and reagents as outlined in Appendix 8.2 will be prepared by QLabs
and shipped to collaborator sites to arrive no later than the Wednesday before
shipment of test portions.
3.5.2
Test kits and Study Materials as outlined in Appendix 8.2 will be shipped to
collaborators by QIAGEN to arrive no later than the Wednesday before
shipment of test portions.
3.5.3
Test portions will be shipped refrigerated by overnight courier to each test site
to arrive on a Friday. The specific date will be determined once collaborators
and sites are confirmed.
3.5.4
All collaborators will begin analyses on the following Monday. Only the
coordinating laboratory will conduct MPN analyses.
3.5.5
Data forms will be completed and emailed to the co-Study Director within 2
weeks of initiation of analyses.
Table 3. Study Schedule (Specific Dates TBD)
Collaborator
Activity
Receipt of
Media and
Reagents
Receipt of Test
Kits and
Materials
Receipt of Test
Portions Set
Initiation of
Analyses
Submission of
Data Report
Form
Date
Week 1,
Wednesday
Week 1,
Wednesday
Week 1,
Friday
Week 2,
Monday
Week 4,
Monday
4.0
Test Portion Preparation and Analysis
4.1
Test Portion Preparation
4.1.1
The Coordinating Laboratory, Q Laboratories, will screen fresh raw ground beef
for natural STEC contamination using the
mericon
E. coli O157 Screen Plus and
OMAMAN-36 B : Collaborative Study Protocol
For ERP Use Only
January 2017
AOAC Research Institute
Expert Review Panel Use Only