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ird
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If the pouch is damaged, do not use. After opening, unused
reagent tubes should always be stored in the resealable pouch
with the desiccant inside to maintain stability of the lyophilized
reagents. Store resealed pouches at 2–8°C for no longer than
60 days. Do not use 3M MDA 2 –
Listeria monocytogenes
past
the expiration date.
(b)
Follow all instructions carefully. Failure to do so may
lead to inaccurate results.
Safety precautions.—
The 3MMDA2 –
Listeria monocytogenes
is intended for use in a laboratory environment by professionals
trained in laboratory techniques. 3M has not documented the use
of this product in industries other than the food and beverage
industries. For example, 3M has not documented this product
for testing drinking water, pharmaceutical, cosmetic, clinical, or
veterinary samples. The 3M MDA 2 –
Listeria monocytogenes
has not been evaluated with all possible food products, food
processes, testing protocols, or with all possible strains of
bacteria.
As with all test methods, the source of enrichment medium can
influence the results. The 3M MDA 2 –
Listeria monocytogenes
has only been evaluated for use with the enrichment media
specified in the manufacturer’s “Instructions for Use.”
The 3M Molecular Detection Instrument is intended for
use with samples that have undergone heat treatment during
the assay lysis step, which is designed to destroy organisms
present in the sample. Samples that have not been properly
heat-treated during the assay lysis step may be considered a
potential biohazard and should NOT be inserted into the 3M
MDS instrument.
The user should read, understand, and follow all safety
information in the instructions for the 3M MDS and the 3M
MDA2 –
Listeria monocytogenes
. Retain the safety instructions
for future reference.
To reduce the risks associated with exposure to chemicals and
biohazards, the following safety precautions should be taken:
Perform pathogen testing in a properly equipped laboratory
under the control of trained personnel. Always follow standard
laboratory safety practices, including wearing appropriate
protective apparel and eye protection while handling reagents
and contaminated samples. Avoid contact with the contents of
the enrichment media and reagent tubes after amplification.
Dispose of enriched samples according to current industry
standards.
L. monocytogenes
is of particular concern for pregnant
women, the aged, and the infirm. It is recommended that
Table 2016.08B. Summary of results for the detection of
L. monocytogenes
in raw chicken breast fillet (25 g)
a
3M MDA 2 –
L. monocytogenes
results
Inoculation level
Uninoculated
Low
High
Candidate presumptive positive/total No. of samples analyzed
0/132
86/132
129/132
POD
CP
0.00 (0.00, 0.03)
0.65 (0.57, 0.73)
0.98 (0.93, 0.99)
s
r
0.00 (0.00, 0.16)
0.48 (0.43, 0.52)
0.15 (0.13, 0.17)
s
L
0.00 (0.00, 0.16)
0.00 (0.00, 0.17)
0.03 (0.00, 0.08)
s
R
0.00 (0.00, 0.23)
0.48 (0.43, 0.52)
0.15 (0.13, 0.18)
P
T
1.0000
0.7057
0.1089
Candidate confirmed positive/total No. of samples analyzed
0/132
86/132
132/132
POD
CC
0.00 (0.00, 0.03)
0.65 (0.57, 0.73)
1.00 (0.97, 1.00)
s
r
0.00 (0.00, 0.16)
0.48 (0.43, 0.52)
0.00 (0.00, 0.16)
s
L
0.00 (0.00, 0.16)
0.00 (0.00, 0.18)
0.00 (0.00, 0.16)
s
R
0.00 (0.00, 0.23)
0.48 (0.43, 0.52)
0.00 (0.00, 0.23)
P
T
1.0000
0.5632
1.0000
Candidate confirmed positive/total No. of samples analyzed
0/132
85/132
129/132
POD
C
0.00 (0.00, 0.03)
0.64 (0.56, 0.73)
0.98 (0.93, 0.99)
s
r
0.00 (0.00, 0.16)
0.48 (0.43, 0.52)
0.15 (0.13, 0.17)
s
L
0.00 (0.00, 0.16)
0.00 (0.00, 0.18)
0.03 (0.00, 0.08)
s
R
0.00 (0.00, 0.23)
0.49 (0.43, 0.52)
0.15 (0.13, 0.18)
P
T
1.0000
0.6228
0.1089
Positive reference samples/total No. of samples analyzed
0/132
64/132
132/132
POD
R
0.00 (0.00, 0.03)
0.48 (0.40, 0.57)
1.00 (0.97, 1.00)
s
r
0.00 (0.00, 0.16)
0.51 (0.46, 0.52)
0.00 (0.00, 0.16)
s
L
0.00 (0.00, 0.16)
0.00 (0.00, 0.14)
0.00 (0.00, 0.16)
s
R
0.00 (0.00, 0.23)
0.51 (0.46, 0.52)
0.00 (0.00, 0.23)
P
T
1.0000
0.9192
1.0000
dLPOD
C
(candidate vs reference)
b
0.00 (−0.03, 0.03)
0.16 (0.04, 0.28)
−0.02 (−0.06, 0.01)
dLPOD
CP
(candidate presumptive vs candidate confirmed)
b
0.00 (−0.03, 0.03)
0.00 (−0.12, 0.12)
−0.02 (−0.06, 0.01)
a
Results include 95% confidence intervals.
b
A confidence interval for dLPOD that does not contain the value 0 indicates a statistical significant difference between the two methods.