772 / 1195
B. (e)
Positive control
solution– (1 x 3 mL). Contains purified and inactivated
Listeria
1
monocytogenes
antigen + preservative + protein stabilizer.
2
B. (f)
Negative control solution
- (1 x 6 mL). Contains Tris-buffered saline (TBS) (150
3
mmol/l) – Tween pH 7.6 + preservative.
4
B. (g)
MLE Card
– One card providing specifications for the factory master data
5
required to calibrate the test: To read the MLE data, please refer to the Operator’s
6
Manual
7
B. (h)
Package insert
.
8
9
Table 2013.1C. Reagents included in 10-well reagent strip
10
11
Wells
Reagents (LMX)
1
Sample well: 0.25 mL of enrichment broth, standard or
control
2
Pre-wash solution (600 µl): TRIS-NaCl (150mmol/l) –
Triton X100 pH 7.6 + preservative
3, 4, 7, 8, 9
Wash buffer (600 µl): TRIS- NaCl(150 mmol/l) -
Tween pH 7.6 + preservative.
5
Conjugate (400 µl): biotin-labeled anti-
Listeria
monocytogenes
antibodies+ preservative.
6
Streptavidin – ALP (400 µl)
10
Reading cuvette with substrate (300 µl):4-Methyl-
umbelliferyl phosphate (0.6 mmol/l) + diethanolamine*
(DEA) (0.62 mol/l or 6.6%, pH 9.2) + preservative.
*Irritant reagent: See VIDAS LMXpackage insert for more information.
12
13
B. (i)
Disposable pipette to dispense appropriate volumes.
14
B. (j)
VIDAS Heat and Go- available from bioMérieux, Inc., (595 Anglum Rd.,
15
Hazelwood, MO 63042-2320, USA).
16
B. (k)
Water bath (95-100°C)
or equivalent system
.
17
B. (l)
Stomacher
®
type bag with filter.
18
B. (m)
Stomacher
– Smasher™ Blender/Homogenizer, Available from
19
bioMérieux, Inc., (595 Anglum Rd., Hazelwood, MO 63042-2320, USA) or
20
equivalent.
21
B. (n)
LMX Broth -
Available from bioMérieux, Inc., (595 Anglum Rd., Hazelwood,
22
MO 63042-2320, USA).
23
B. (o)
Supplement for LMX Broth
24
B. (p)
LPT Broth -
Available from bioMérieux, Inc., (595 Anglum Rd., Hazelwood, MO
25
63042-2320, USA).
26
B. (q)
Incubators.
– Capable of maintaining 37 ± 1°C, 35 ± 1°C and
30 ±1°C.
27
B. (r)
Diagnostic reagents-
Necessary for culture confirmation of assays.
28
B. (s)
ALOA Chromogenic Agar -
Necessary for cultural confirmation as an alternative
29
to selective agar required by appropriate reference method. Available from
30
bioMérieux, Inc., (595 Anglum Rd., Hazelwood, MO 63042-2320, USA).
31
B. (t)
Tryptic Soy Agar with yeast additive.
32
33
34
C. General Instructions
35
6