3
Molecular Detection Assay 2 - Listeria monocytogenes
Product Description and Intended Use
3M™ Molecular Detection Assay 2 - Listeria monocytogenes is used with the 3M™ Molecular Detection System for the
rapid and specific detection of Listeria monocytogenes in enriched food and environmental samples.
The 3M Molecular Detection Assays use loop-mediated isothermal amplification to rapidly amplify nucleic acid sequences
with high specificity and sensitivity, combined with bioluminescence to detect the amplification. Presumptive positive
results are reported in real-time while negative results are displayed after the assay is completed. Presumptive positive
results should be confirmed using your preferred method or as specified by local regulations
The 3M Molecular Detection Assay 2 - 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 food
or beverage. For example, 3M has not documented this product for testing water, pharmaceutical, cosmetics, clinical or
veterinary samples. The 3M Molecular Detection Assay - 2 Listeria monocytogenes has not been evaluated with all possible
testing protocols or with all possible strains of bacteria.
As with all test methods, the source, formulation and quality of enrichment medium can influence the results. Factors
such as sampling methods, testing protocols, sample preparation, handling, and laboratory technique may also influence
results. 3M recommends evaluation of the method including enrichment medium, in the user's environment using a
sufficient number of samples with particular foods and microbial challenges to ensure that the method meets the user's
criteria.
3M has evaluated the 3M Molecular Detection Assay 2 - Listeria monocytogenes with Demi-Fraser Broth containing Ferric
Ammonium Citrate and Fraser Broth containing Ferric Ammonium Citrate as needed. A typical formulation of this medium
follows below.
Demi-Fraser Broth Base Typical Formula
Sodium Chloride
Sodium Phosphate, dibasic, anhydrous *
Beef Extract
Pancreatic Digest of Casein
Peptic Digest of Animal Tissue
Yeast Extract
Lithium Chloride
Potassium Phosphate, monobasic
Esculin
Acriflavin HCl
Nalidixic Acid
* Substitute: Sodium Phosphate, dibasic, dihydrate 12.0 g
Fraser Broth Supplement
(Ingredients per 10 mL vial. One vial is added to one liter of basal medium.)
Ferric Ammonium Citrate
Final pH 7.2 ± 0.2 at 25°C
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
Molecular Detection Instrument.
3M Food Safety is certified to ISO (International Organization for Standardization) 9001 for design and manufacturing.
The 3M Molecular Detection Assay 2 - Listeria monocytogenes test kit contains 96 tests, described in Table 1.
(g/L)
20 g
9.6 g
5.0 g
5.0 g
5.0 g
5.0 g
3.0 g
1.35 g
1.0 g
0.0125 g
0.01 g
0.5g/10mL
Product Instructions
Fraser Broth Base Typical Formula
Sodium Chloride
Sodium Phosphate, dibasic, anhydrous
Beef Extract
Pancreatic Digest of Casein
Peptic Digest of Animal Tissue
Yeast Extract
Lithium Chloride
Potassium Phosphate, monobasic
Esculin
Acriflavin HCl
Nalidixic Acid
1
(English)
EN
Issue Date: 2016-10
.
(1, 2, 3)
(g/L)
20 g
9.6 g
5.0 g
5.0 g
5.0 g
5.0 g
3.0 g
1.35 g
1.0 g
0.025 g
0.02 g