900-901 / 1195
5
c)
Test Kit Components
1
i.
60 LMX Strips
.
2
ii.
60 LMX SPR®s
.-Interior of SPR®s coated with antibodies directed against
L. monocytogenes
specific antigens.
3
iii.
LMX Standard (1 x 6 mL).-
Ready-to-use. Purified and inactivated
L. monocytogenes
antigen + preservative + protein
4
stabilizer. The confidence interval is indicated on the MLE card after the following mention: "Standard (S1) RFV Range".
5
iv.
LMX Positive Control (1 x 3 mL)
.-Purified and inactivated
L. monocytogenes
antigen + preservative + protein stabilizer. The
6
confidence interval is indicated on the MLE card after the following mention: "Control C1 (+) Test Value Range".
7
v.
Negative Control (1 x 6 mL)
.-TRIS buffered saline (TBS) (150 mmol/L) - Tween pH 7.6 + preservative. The maximum
8
acceptable value for the test is indicated on the MLE card after the following mention: "Control C2 (-) Test Value Range".
9
vi.
1 MLE Card (Master Lot Entry)
.-Specifications for the factory master calibration data required to calibrate the test: to read the
10
MLE data, please refer to the Operator’s Manual.
11
d)
Additional Supplies and Reagents
12
i.
Supplement for LMX Broth (LMX SUPP)
- (bioMérieux ref. 42648).
13
ii.
LMX Broth
.
14
a.
3-liter bag (bioMérieux ref. 42649).
15
b.
225 ml in a 250 mL bottle (bioMérieux ref. 42647).
16
c.
225 ml mini-bag (bioMérieux ref. 42749)
17
iii.
LX Broth in 6 mL tubes
- (bioMérieux ref. 42117).
18
iv.
ChromID Ottaviani Agosti
(OAA)- (bioMérieux ref. 43641 or 43649).
19
v.
ChromID L.mono agar - (bioMérieux ref. 43661)
20
vi.
Disposable pipettes -
to dispense 0.25 ml and 500 μL.
21
22
Apparatus
23
24
a)
VIDAS® instrument
.
25
b)
Disposable pipettes
- to dispense 0.25 ml and 500 μL.
26
c)
VIDAS® Heat and Go
- (bioMérieux ref. 93554 or 93555 or 93556: Contact your bioMerieux representative) or a water-bath
27
(95-100°C) or an equivalent system.
28
d)
Stomacher-type mixer
.
29
e)
Stomacher-type bag with filter
.
30
31
Safety Precautions
32
PTM Certification Report