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QIAGEN
mericon
STEC Workflow Collaborative Study Protocol
May 2016
DRAFT
18
on the designated day. Immediately upon receiving the shipment, confirm the contents with the
Study Director by faxing or emailing the form provided in the shipment.
4.
THIS IS A STUDY OF THE METHOD, NOT OF THE LABORATORY. THE METHOD MUST BE FOLLOWED
AS CLOSELY AS PRACTICABLE, AND ANY DEVIATIONS FROM THE METHOD AS DESCRIBED, NO
MATTER HOW TRIVIAL THEY MAY SEEM, MUST BE NOTED ON THE REPORT FORM.
5.
Report all of your results as soon as analyses are completed. Do not do more or less than indicated
in the instructions. For example, do not do duplicate analyses and report the best or average result.
More or fewer results complicate the statistical analyses and may invalidate your results. Data
sheets are provided with instructions and indicate which results to report. A space is provided on
the Data Report Form to indicate any deviations to the methods or the instructions to collaborators.
Please include any criticisms, suggested improvements, or general comments about the products on
the Collaborators’ Comments Form provided. Any results that were derived from modified
protocols should be included but must be clearly indicated. Results and comments should be
returned to the Study Director immediately upon completion of the study.
Information about this Collaborative Study
Shipment Schedule and Receipt of Study Materials and Test Portions
All test kits, study materials, media and reagentsas outlined in Appendix 8.2 should be received by
Wednesday of Week 1. If all collaborators are not on-site at the time of arrival, a designated site
coordinator shall receive the materials. Collaborators or site coordinators shall inventory all test
kits,study materials, media and reagents against the packing lists upon arrival to ensure all materials
have arrived. Contact co-Study Director Marcia Armstrong if any test kits or study materials have not
arrived by Wednesday.Contact co-Study Director Erin Crowley if enrichment media and IMS reagents
have not arrived by Wednesday.
Test portions will be shipped by overnight courieron Thursday of Week 1 to arrive on Friday. If all
collaborators are not on-site at the time of arrival, a designated site coordinator shall receive the
packages. Each package shall be examined for potential damage. The collaborator or site coordinator
must alert co-Study Director Erin Crowley if any packages appear compromised or if the contents are not
cold to the touch. Each package will contain a clearly labeled temperature control sample. The
collaborator or site coordinator should quickly take a temperature measurement of the core of this
sample and record the temperature reading on the Data Report Form. If the temperature of this control
sample is outside the range 2-8°C, co-Study Director Erin Crowley should be alerted. Each package of
ground beef should contain 36 test portions labeled X01-X36, where X is a number between 1 and 16,
unique for each collaborator so you can distinguish your test portions from the test portions for other
collaborators at the same site. In addition, there should be one additional test portion in each package
designated for aerobic plate count determination. Inventory the test portions to be sure all are present
and alert co-Study Director Erin Crowley if any test portions are missing.The test portions should be
stored at 2-8°C until initiation of the study on the following Monday.
OMAMAN-36 B : Collaborative Study Protocol
For ERP Use Only
January 2017
AOAC Research Institute
Expert Review Panel Use Only