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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
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ATCC = American Type Culture Collection
2
3
Lot-to-Lot and Stability Studies
4
5
Real Time Stability/Shelf-life
6
7
Methodology
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Real time stability was tested according to bioMérieux procedure: two
Listeria monocytogenes
strains,
Listeria monocytogenes
4b
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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:
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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,
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PTM Certification Report