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QIAGEN mericon STEC Workflow Collaborative Study Protocol May 2016
DRAFT 5
1.3 Co-Study Directors for the Collaborative Study
Marcia Armstrong
QIAGEN, Inc.
Global Scientific Affairs Manager
Applied Testing – Food Safety
19300 Germantown Road
Germantown, MD 20874
617-852-8131
Erin Crowley
Microbiology R&D Supervisor
Q Laboratories, Inc.
1400 Harrison Ave.
Cincinnati, OH 45214
513-471-1300
2.0 Collaborators
A minimum of 10 valid data sets are needed for the successful completion of this study, so 12-15
collaborators will be solicited to participate. Qualified analysts, familiar with the mericon® Pathogen
Detection System, will act as collaborators. All collaborators have been, or will be, thoroughly trained by
a QIAGEN representative on the use of the mericon® System (QIAsymphony SP/AS and Rotor-Gene Q).
QLabs will provide 3 collaborators. Additional collaborator sites could include Vanguard, FSNS, Covance,
Aemtek, Microbac, Silliker, Tyson or Marshfield. Each site must have a large Stomacher or similar
homogenization equipment and preferably will be able to confirm all test portion sets at that site. In the
event a site cannot accommodate the confirmation of all test portion sets, they must be able to ship
infectious samples to QLabs for confirmation. QLabs can accommodate the confirmation of up to 3 test
portion sets in addition to the 3 test portions sets from their own laboratory. A sample letter to
collaborators can be found in Appendix 8.1. This letter will be sent to each collaborator prior to the start
of the study. In addition, a conference call will be held with collaborators to review the study protocol in
detail and answer any questions before the start of the study.
3.0 Collaborative Study Design
3.1 The study will include 4-5 test sites, with no more than 3 collaborators at each site. The
collaborators at each site will share the use of a mericon® system (QIAsymphony SP/AS
and Rotor-Gene Q). The three collaborators may be three analysts employed at that
site, but working independently.
3.2 The mericon E. coli O157 Screen Plus and mericon E. coli STEC O-Type methods will be
validated together as one workflow and will comprise one Official Method. The method
will include both manual and automated sample prep and assay setup options and will
be applicable to ground beef and beef trim. Spinach will not be included in the OMA
claim.
3.3 One matrixis proposed. Fresh raw ground beef (325 g test portion size) artificially
inoculated with E. coliO157:H7 will be analyzed in a paired study design by the mericon
workflow and the FSIS MLG 5.09 reference method.
OMAMAN-36 B : Collaborative Study Protocol
For ERP Use Only
January 2017
AOAC Research Institute
Expert Review Pan l Use Only