914-915 / 1195
12
CFU/ml
TV
CFU/ml
TV
CFU/ml
TV
S1
2110-4600 *
NA
3410 *
NA
3332 *
NA
3144 *
C2
TV < 0.05
NA
0.00
NA
0.0
NA
0.00
L.monocytogenes
4b
TV
≥
0.05 for
10
5
CFU/ml
1.1x10
5
0.23
2.2x10
5
0.20
1.5x10
5
0.19
2.2x10
4
0.12
4.4x10
4
0.06
7.4x10
4
0.05
L.monocytogenes
4e
TV
≥
0.05 for
10
5
CFU/ml
9.0x10
4
0.13
3.0x10
5
0.67
3.8x10
4
0.34
1.8x10
4
0.08
5.0x10
4
0.23
7.5x10
3
0.14
S.aureus
TV < 0.05
>10
8
0.00
Pure
0.00
>1x10
8
0.02
B.cereus
TV < 0.05
>10
8
0.00
Pure
0.00
>1x10
8
0.02
1
TV=Test Value, * S1 results provided in Relative Fluorescence value, NA= not applicable
2
3
Lot-to-Lot Consistency
4
Methodology
5
For the lot-to-lot consistency study, 3 lots of test kits were tested: one lot after production, a second lot approximately in the middle of
6
expiration (6 months) and a third lot at the end of the expiration date (12 months). For each of the 3 lots of LMX test kits, two strains
7
of
Listeria monocytogenes
were tested within one log of the limit of detection of the LMX test kit. One non-target strain
(
Bacillus
8
cereus
) was analyzed at the growth level achieved in a non-selective broth (TSBYE) after 24 hours at 37
°
C.
9
10
11
Results
12
When comparing values between the 3 lots, there were no significant differences in test kit results with all comparative test values.
13
Results from the Lot-to-lot consistency study support the good inter lots reproducibility of the VIDAS LMX reagents. The results of
14
the lot-to-lot consistency study are presented in Table 4.
15
16
PTM Certification Report