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B. (a)
VIDAS or miniVIDAS automated immunoassay System.
1
B. (b)
LPT Reagent strips-
60 polypropylene strips of 10 wells, each strip covered with a
2
foil seal and label. The 10 wells contain the reagents in Table 2013.1C.
3
B. (c)
Solid-phase receptacle (SPR). -
60 SPRs coated with proteins specific
4
for
Listeria
receptors
.
5
B. (d)
Standard-
One vial (1 x 6 mL). Ready to use. Contains purified and inactivated
6
Listeria
receptors + preservative + protein stabilizer.
7
B. (e)
Positive control solution
– (1 x 6 mL). Contains purified and inactivated
Listeria
8
monocytogenes
antigen + preservative + protein stabilizer.
9
B. (f)
Negative control solution
- (1 x 6 mL). Contains Tris-buffered saline (TBS) (150
10
mmol/l) – Tween pH 7.6 + preservative.
11
B. (g)
MLE Card
– One card providing specifications for the factory master data
12
required to calibrate the test: To read the MLE data, please refer to the Operator’s
13
Manual
14
B. (h)
Package insert
.
15
16
Table 2013.1C. Reagents included in 10-well reagent strip
17
18
Wells
Reagents (SLM)
1
Sample well: 0.5 mL of enrichment broth, standard or
control
2
Pre-wash solution (400 µl): TRIS-NaCl (150mmol/l) -
Tween pH 7.6 + preservative
3-5, 7-9
Wash buffer (600 µl): TRIS- NaCl(150 mmol/l) -
Tween pH 7.6 + preservative.
6
Conjugate (400 µl): alkaline phosphatase-labeled
proteins specific for
Listeria
receptors + preservative.
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 LPTpackage insert for more information.
19
20
B. (i)
Disposable pipette to dispense appropriate volumes.
21
B. (j)
VIDAS Heat and Go- available from bioMérieux, Inc., (595 Anglum Rd.,
22
Hazelwood, MO 63042-2320, USA).
23
B. (k)
Water bath (95-100°C)
or equivalent system.
24
B. (l)
Stomacher
®
type bag with filter.
25
B. (m)
Stomacher
– Smasher™ Blender/Homogenizer, Available from bioMérieux, Inc.,
26
(595 Anglum Rd., Hazelwood, MO 63042-2320, USA) or equivalent.
27
B. (n)
LPT Broth -
Available from bioMérieux, Inc., (595 Anglum Rd., Hazelwood, MO
28
63042-2320, USA).
29
B. (o)
Incubators.
– Capable of maintaining 30 ± 1°C and
35 ±1°C.
30
B. (p)
Diagnostic reagents-
Necessary for culture confirmation of assays.
31
B. (q)
ALOA Chromogenic Agar -
Necessary for cultural confirmation as an alternative
32
to selective agar required by appropriate reference method. Available from
33
bioMérieux, Inc., (595 Anglum Rd., Hazelwood, MO 63042-2320, USA).
34
B. (r)
Tryptic Soy Agar with yeast additive.
35
36
C. General Instructions
37
6