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1400 Harrison Ave
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Cincinnati, OH 45214
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Reviewers
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Yvonne Salfinger
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Consultant
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Denver, CO
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Michael Brodsky
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Brodsky Consultants
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73 Donnamora Crescent
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Thornhill, Ontario L3T 4K6
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Canada
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Reviewer
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Tony Hitchins
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FDA-Retired
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Rockville, MD
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Scope of Method
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a)
Target organism
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— Listeria monocytogenes
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b)
Matrices
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—
Beef hot dogs (25 g), deli turkey (125 g), queso fresco (25 g), vanilla ice cream
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(25 g), 4% milk fat cottage cheese (25 g), 3% chocolate whole milk (25 mL), whole melon,
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romaine lettuce (25 g), bagged raw spinach (25 g), cold smoked salmon (25 g), raw chicken
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leg pieces (25 g), sealed concrete (sponge enriched in 100 mL, 4” x 4”), plastic (Enviroswab
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enriched in 10 mL, 1” x 1”), stainless steel (sponge enriched in 225 mL, 4” x 4”).
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c)
Summary of Validated Performance Claims
.
—
Performance equivalent to that of the U.S.
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Food and Drug Administration
Bacteriological Analytical Manual
(FDA/BAM) Chapter 10
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[1] for whole melon, cold smoked salmon, romaine lettuce; the U.S. Department of
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Agriculture Food Safety and Inspection Service
Microbiology Laboratory Guidebook
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(USDA-FSIS/MLG) 8.09 [2] for beef hot dogs, deli turkey, raw chicken leg pieces, sealed
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concrete, plastic and stainless steel and AOAC 993.12 [3] for queso fresco, vanilla ice cream,
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4% milk fat cottage cheese, 3% chocolate whole milk and theISO 11290-1/A1 [4]for cold
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smoked salmon and bagged raw spinach.
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Definitions
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a)
Probability of Detection (POD).—
The proportion of positive analytical outcomes for a
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qualitative method for a given matrix at a given analyte level or concentration. POD is
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concentration dependent. Several POD measures can be calculated; POD
R
(reference method
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POD), POD
C
(confirmed candidate method POD), POD
CP
(candidate method presumptive
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result POD) and POD
CC
(candidate method confirmation result POD).
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AOAC Research Institute
Expert Review Panel Use Only
OMAMAN-30 D/ PTM Validation Report 081501
OMA ERP - June 2016
ERP Use Only