3M Molecular Detection Assay 2 Manuel D'instructions page 5

Storage and Disposal
Store the 3M Molecular Detection Assay 2 - Listeria at 2-8°C. Do not freeze. Keep kit away from light during storage.
After opening the kit, check that the foil pouch is undamaged. If the pouch is damaged, do not use. After opening, unused
reagent tubes should always be stored in the re-sealable 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 Molecular Detection Assay 2 - Listeria past the expiration date. Expiration date and lot number are noted
on the outside label of the box. After use, the enrichment medium and the 3M Molecular Detection Assay 2 - Listeria tubes
can potentially contain pathogenic materials. When testing is complete, follow current industry standards for the disposal
of contaminated waste. Consult the Safety Data Sheet for additional information and local regulations for disposal.
Instructions for Use
Follow all instructions carefully. Failure to do so may lead to inaccurate results.
The user should complete the 3M Molecular Detection System operator qualification training, as described in the
"Installation Qualification (IQ) / Operational Qualification (OQ) Protocols and Instructions for 3M Molecular Detection
System" document .
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Periodically decontaminate laboratory benches and equipment (pipettes, cap/decap tools, etc.) with a 1- 5% (v:v in water)
household bleach solution or DNA removal solution.
See Section "Specific Instructions for validated methods" for specific requirements:
Table 3 for enrichment protocols according to AOAC
#111501
Table 4 for enrichment protocols according to NF Validation certificate 3M 01/14-05/16
Sample Enrichment
Tables 2, 3 or 4 present guidance for the enrichment of food and environmental samples. It is the user's responsibility to
validate alternate sampling protocols or dilution ratios to ensure this test method meets the user's criteria.
Foods
1. Allow the Demi-Fraser Broth enrichment medium (includes ferric ammonium citrate) to equilibrate to ambient laboratory
temperature.
2. Aseptically combine the enrichment medium and sample according to Tables 2, 3 or 4. For all meat and highly
particulate samples, the use of filter bags is recommended.
3. Homogenize thoroughly by blending, stomaching, hand mixing for 2 ±0.2 minutes. Incubate at 37 ±1°C according to
Tables 2, 3 or 4.
4. For raw dairy products, transfer 0.1 mL of the primary enrichment into 10 mL of Fraser Broth. Incubate at 37 ±1°C for
20-24 hours.
Environmental samples
Sample collection devices can be a sponge hydrated with a neutralizing solution to inactivate the effects of the sanitizers.
3M recommends the use of a biocide-free cellulose sponge. Neutralizing solution can be Dey-Engley (D/E) Neutralizing
Broth or Letheen broth. It is recommended to sanitize the area after sampling.
WARNING: Should you select to use Neutralizing Buffer (NB) that contains aryl sulfonate complex as the hydrating
solution for the sponge, it is required to perform a 1:2 dilution (1 part sample into 1 part sterile enrichment broth) of the
enriched environmental sample before testing in order to reduce the risks associated with a false-negative result leading
to the release of contaminated product.
The recommended size of the sampling area to verify the presence or absence of the pathogen on the surface is at least
100 cm (10 cm x 10 cm or 4"x4"). When sampling with a sponge, cover the entire area going in two directions (left to right
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then up and down) or collect environmental samples following your current sampling protocol or according to the FDA
BAM , USDA FSIS MLG
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1. Allow the Demi-Fraser Broth enrichment medium (includes ferric ammonium citrate) to equilibrate to ambient laboratory
temperature.
2. Aseptically combine the enrichment medium and sample according to Tables 2, 3 or 4.
3. Homogenize thoroughly by blending, stomaching, hand mixing or vortexing for 2 ±0.2 minutes. Incubate at 37 ±1°C for
24-30 hours according to Tables 2, 3 or 4.
or ISO 18593 guidelines.
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Official Method 2016.07 and Performance Tested
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