3M Listeria MDAL96 Manual Del Usuario página 2

3
Molecular Detection Assay Listeria
PRODUCT DESCRIPTION AND INTENDED USE
3M™ Molecular Detection Assay Listeria is used with the 3M™ Molecular Detection System for the rapid and specific detection of Listeria species 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 (1,2,3) .
The 3M Molecular Detection Assay Listeria 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 Listeria has not been evaluated with all possible testing
protocols or with all possible strains of bacteria.
As with all test methods, the source of enrichment medium can influence the results. 3M has evaluated the 3M Molecular Detection Assay Listeria
with 3M™ Modified Listeria Recovery Broth (mLRB), Demi-Fraser Broth Base and Fraser Broth Base (typical formulations of these media follow
below).
Do not use Demi-Fraser Broth Base or Fraser Broth Base containing ferric ammonium citrate (FAC), either already in the broth base or as an
added supplement, when using the 3M Molecular Detection Assay Listeria.
Demi-Fraser Broth Base Typical Formula (g/L)
Sodium Chloride
Sodium Phosphate, dibasic
Beef Extract
Pancreatic Digest of Casein
Peptic Digest of Animal Tissue
Yeast Extract
Lithium Chloride
Potassium Phosphate, monobasic
Esculin
Acriflavin HCl
Nalidixic Acid
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 Listeria test kit contains 96 tests, described in Table 1.
Table 1. Kit Components
Item Identification
Lysis Solution (LS) tubes Clear tubes
Listeria Reagent tubes Blue tubes
Extra caps Blue caps
Negative Control (NC) Blue cap
Reagent Control (RC) Clear flip-top tubes
Quick Start Guide
Fraser Broth Base Typical Formula (g/L)
20 g Sodium Chloride
9.6 g Sodium Phosphate, dibasic
5.0 g Beef Extract
5.0 g Pancreatic Digest of Casein
5.0 g Peptic Digest of Animal Tissue
5.0 g Yeast Extract
3.0 g Lithium Chloride
1.35 g Potassium Phosphate, monobasic
1.0 g Esculin
0.0125 g Acriflavin HCl
0.01 g Nalidixic Acid
Final pH 7.2 ± 0.2 at 25°C
Quantity
96 (12 strips of 8 tubes)
96 (12 strips of 8 tubes)
96 (12 strips of 8 caps)
1 tube
16 (2 pouches of 8 individual tubes)
1
1
(English)
Product Instructions
1.35 g
0.025 g
0.02 g
Contents
580 μL of LS per tube
Lyophilized specific
amplification and detection mix
1 mL Molecular grade water
Lyophilized control DNA,
amplification and detection mix
Issue Date: 2015-02
MDAL96
20 g
9.6 g
5.0 g
5.0 g
5.0 g
5.0 g
3.0 g
1.0 g
Comments
Racked and ready to
use
Ready to use
Ready to use
Ready to use
Ready to use