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potentially infectious and handled observing the usual safety precautions (do not

1

ingest or inhale)

2

3

Inclusivity Study

4

Methodology

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The purpose of inclusivity testing is to ensure that the VIDAS LPTtest can detect a

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representative range of

Listeria

. All cultures used for inclusivity testing were checked for

7

purity prior to testing. Fifty

Listeria

strains (25

L. Monocytogenes

and 25 other

Listeria

8

species)

were enriched in LPT broth for 26h at 30°C and tested on the VIDAS LPT assay.

9

10

Results

11

The inclusivity results are presented in Table 1. All

Listeria

strains tested were detected by the

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VIDAS LPT assay.

13

14

Exclusivity study

15

Methodology

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The purpose of exclusivity testing is to determine the ability of the LPT method to

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discriminate target organisms from non-target organisms. Thirty non-

Listeria

strains were

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cultivated in TSB+YE broth for 26h at 37°C and then tested using the VIDAS LPT assay.

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Results

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The exclusivity results are presented in Table 2. The thirty non-

Listeria

strains tested

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were negative by the VIDAS LPT assay.

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Method Comparison Study - Foods

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This precollaborative study was conducted with reference to AOAC guidelines (6)

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outlined in the AOAC General Referee approved harmonized PTM/OMA protocol. The

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method comparison study consisted of evaluation of the LPT compared to various

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reference methods depending on the food type. Seven foods (deli ham, pepperoni, beef

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hot dogs, chicken nuggets, chicken liver paté, ground beef, deli turkey) as well as 4

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environmental surfaces (plastic, stainless steel, ceramic and concrete) were tested at

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contract laboratories comparing the LPT method and the USDA/FSIS MLG method.

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Dairy foods (vanilla ice cream and soft cheese were tested by both the AOAC method

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(993.12) and the LPT method. Six other foods (cooked shrimp, smoked salmon,

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cantaloupe, bagged mixed salad, peanut butter and black pepper were tested by the LPT

33

method and compared to the FDA-BAM method. A background screen of each food was

34

conducted prior to inoculation and natural contamination of

Listeria

was not detected for

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any food. A total plate count was also performed on each food to determine the

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microbial load. Within each sample set there were 5 uninoculated samples and 20 low-

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level inoculated samples for each method. The target levels of the organism used for

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challenging each food matrix was as follows: 0.2-2 colony forming units (cfu)/25g of

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