279 / 596
b)
Difference of Probabilities of Detection (dPOD).—
Difference of probabilities of detection is
1
the difference between any two POD values. If the confidence interval of a dPOD does not
2
contain zero, then the difference is statistically significant at the 5% level.
3
4
Principle of the Method
5
6
3M™ Molecular Detection Assay 2 –
Listeria monocytogenes
is used with the 3M™ Molecular
7
Detection System for the rapid and specific detection of
Listeria
species in enriched food and
8
environmental samples.
9
The 3M Molecular Detection Assays use loop-mediated isothermal amplification to rapidly
10
amplify nucleic acid sequences with high specificity and sensitivity, combined with
11
bioluminescence to detect the amplification. Presumptive positive results are reported in real-
12
time while negative results are displayed after the assay is completed. Presumptive positive
13
results should be confirmed using the laboratory’spreferred method or as specified by local
14
regulations.
15
16
General Information
17
18
Listeria
is a small, Gram-positive rod that can be found in soil or carried by animals. Many
19
foods have been associated with
Listeria
contamination: uncooked meats, uncooked
20
vegetables, cantaloupe, pasteurized and unpasteurized milk, and other dairy and processed
21
foods. [5] The resulting illness, listeriosis, from
Listeria monocytogenes
ingestion is rare but
22
can be fatal. The disease may appear as meningitis in adults and can affect unborn children
23
due to its ability to cross through the placenta.
Listeria
contamination often occurs post-
24
cooking, before packaging as
Listeria
can survive longer under adverse environmental
25
conditions that can most other vegetative bacteria that present a concern for the food safety
26
industry. [6] Manufacturing facilities implement sanitation practices and regular surface
27
screening for the presence of
Listeria
on food contact surfaces to monitor their food
28
production environments. The 3M MDA2–
Listeriamonocytogenes
was developed to provide
29
rapid and specific detection of
Listeria monocytogenes
in enriched food samples and on food
30
processing surfaces.
31
32
Materials and Methods
33
34
Test Kit Information
35
36
a)
Kit Name.
—
Molecular Detection Assay 2 –
Listeriamonocytogenes
37
b)
Catalog Number
.
—
MDA2LM96
38
39
Test Kit Reagents -
3M MDA2 –
Listeria monocytogenes
(96 tests)
40
a)
Lysis Solution (LS) tubes
. – 96 (12 strips of 8 tubes)
41
b)
Listeria monocytogenes Reagent tubes
. – 96 (12 strips of 8 tubes)
42
c)
Extra caps.
– 96 (12 strips of 8 caps)
43
d)
Reagent Control (RC).
– 16 (2 pouches of 8)
44
e)
Quick Start Guide
45
46
Additional Supplies and Reagents
47
AOAC Research Institute
Expert Review Panel Use Only
OMAMAN-30 D/ PTM Validation Report 081501
OMA ERP - June 2016
ERP Use Only