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10

L64

Listeria innocua

Raw milk cheese

0.04

-

L76

Listeria innocua

6b

Ground beef

0.04

-

L80

Listeria ivanovii

Institut Pasteur Collection

0.00

-

L83

Listeria seeligeri

1/2b

Pork tongue

0.00

-

L91

Listeria welshimeri

Sausage

0.02

-

L108

Listeria innocua

Gorgonzola

0.03

-

L142

Listeria seeligeri

Raw milk cheese

0.00

-

L151

Listeria ivanovii

Ground beef

0.01

-

Stains tested after enrichment in LMX broth

ST17

Staphylococcus aureus

Yoghurt

0.00

-

ST3

Staphylococcus epidermidis

Yoghurt

0.00

-

TV=Test Value, Positive results = TV

0.05, negative results = TV< 0.05

1

ATCC = American Type Culture Collection

2

3

Lot-to-Lot and Stability Studies

4

5

Real Time Stability/Shelf-life

6

7

Methodology

8

Real time stability was tested according to bioMérieux procedure: two

Listeria monocytogenes

strains,

Listeria monocytogenes

4b

9

ATCC 19115 and

Listeria monocytogenes

4e bioMérieux ref 83.09.033, enriched in TSBYE broth for 24 hours at 37°C, were analyzed

10

at two dilutions close to the limit of detection of the kit. Two negative strains,

Staphylococcus aureus

ATCC 6538 and

Bacillus cereus

11

ATCC 27522, were analyzed at the growth level achieved in a non-selective broth (TSBYE), incubated for 24 hours at 37°C. In

12

addition, the test kit standard (S1) containing inactivated

Listeria monocytogenes

antigen and the LMX test kit negative control were

13

also tested. Each sample was tested with the VIDAS LMX assay as defined in the package insert: in single for the strains and the

14

negative control, in duplicates for the standard.

15

Acceptance criteria:

16

Standard S1: the value must be within the set Relative Fluorescence Values defined for each lot,

17

Negative control: the test value must be below 0.05,

18

Listeria monocytogenes

strains: a positive result (test value higher or equal to 0.05) must be obtained at a level of 10

5

CFU/ml,

19

PTM Certification Report