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VIDAS LMX & LPT Collaborative Study
April 19, 2013
OMA-2013-Apr-XXX
Ronald
Johnson
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bioMérieux Industry
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595 Anglum Road
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Hazelwood, Missouri 63042
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Phone: 314-731-7343
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Fax: 314-731-8678
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Email:
ron.johnson@na.biomerieux.com7
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Co-SD: TBD
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2.0
Collaborators
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A total of 15-16 collaborators will be solicited to participate in this study. A minimum of
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10 laboratories, with acceptable data, will be needed for the successful completion of this
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study. Qualified laboratories currently using the VIDAS system will act as collaborators.
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All collaborators have been, or will be, thoroughly trained by a bioMérieux representative
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on the VIDAS.
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A sample letter to collaborators can be found in Appendix 8.1. This letter will be sent to
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each collaborator prior to the start of the study.
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3.0
Collaborative Study Design
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3.1
The laboratory conducting the study will prepare the test portions to be sent to the
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collaborators. In this study, soft Mexican cheese will be tested using the
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following parameters:
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3.1.1
25g spiked with
L. monocytogenes
will be enriched with supplemented
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LMX broth followed by the VIDAS LMX kit,
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3.1.2
25g spiked with
L. innocua
will be enriched with LPT broth followed by
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the VIDAS LPT kit; and
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3.1.3
125g spiked with
L. monocytogenes
will be enriched with LPT broth
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followed by both the VIDAS LMX and LPT methods.
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3.1.4
Each scenario above will be compared to 25g enriched with complete
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selective enrichment medium following the AOAC 993.12 reference
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method.
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3.2
Each week, collaborators will receive 36 samples soft Mexican cheese: 12
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uninoculated controls, 12 low level (target 0.2 – 2.0 cfu/test portion), and 12 high
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level (target 2–5 cfu/test portion). See flow diagram 9.5 for the study diagram.
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Each laboratory will test all test portions. Each test portions will be inoculated
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with a strain of
L. monocytogenes
as listed in Table 1, randomized and blind-
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coded for analysis.
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DRAFT DOCUMENT
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