6. Review and confirm the configured run in the 3M Molecular Detection Software.
7. Click the Start button in the software and select instrument for use. The selected instrument's lid automatically opens.
8. Place the 3M Molecular Detection Speed Loader Tray into the 3M Molecular Detection Instrument and close the lid to start the assay. Results are
provided within 75 minutes, although positives may be detected sooner.
9. After the assay is complete, remove the 3M Molecular Detection Speed Loader Tray from the 3M Molecular Detection Instrument and dispose of
the tubes by soaking in a 1-5% (v:v in water) household bleach solution for 1 hour and away from the assay preparation area.
NOTICE: To minimize the risk of false positives due to cross-contamination, never open reagent tubes containing amplified DNA. This includes
Reagent Control, Reagent, and Matrix Control tubes. Always dispose of sealed reagent tubes by soaking in a 1-5% (v:v in water) household bleach
solution for 1 hour and away from the assay preparation area.
RESULTS AND INTERPRETATION
An algorithm interprets the light output curve resulting from the detection of the nucleic acid amplification. Results are analyzed automatically by the
software and are color-coded based on the result. A Positive or Negative result is determined by analysis of a number of unique curve parameters.
Presumptive positive results are reported in real-time while Negative and Inspect results will be displayed after the run is completed.
Presumptive positive samples should be confirmed as per the laboratory standard operating procedures or by following the appropriate reference
method confirmation
, beginning with transfer from the primary enrichment to secondary enrichment broth (if applicable), followed by subsequent
(1,2,3)
plating and confirmation of isolates using appropriate biochemical and serological methods.
NOTE: Even a negative sample will not give a zero reading as the system and 3M Molecular Assay Listeria amplification reagents have a
"background" relative light unit (RLU).
In the rare event of any unusual light output, the algorithm labels this as "Inspect." 3M recommends the user to repeat the assay for any Inspect
samples. If the result continues to be Inspect, proceed to confirmation test using your preferred method or as specified by local regulations
If you have questions about specific applications or procedures, please visit our website at www.3M.com/foodsafety or contact your local 3M
representative or distributor.
REFERENCES:
1. US Food and Drug Administration Bacteriological Analysis Manual. Chapter 10: Detection and Enumeration of Listeria monocytogenes in Foods.
Section C-6. April 2011 Version.
2. US Department of Agriculture (USDA) FSIS Microbiology Laboratory Guidebook 8.08. Isolation and Identification of Listeria monocytogenes from
Red Meat, Poultry and Egg Products, and Environmental Samples. Effective Date: 6 Nov 2012.
3. ISO 11290-1. Microbiology of Food and Animal Feeding Stuffs – Horizontal Method for the Detection and Enumeration of Listeria monocytogenes.
Amendment 1, 2004-10-15.
4. ISO/IEC 17025. General requirements for the competence of testing and calibration laboratories.
5. ISO 7218. Microbiology of food and animal feeding stuffs – General rules for microbiological examination.
6. ISO 18593. Microbiology of food and animal feeding stuffs – Horizontal methods for sampling techniques from surfaces using contact plates and
swabs.
ExPLANATION OF PRODUCT LABEL SYMBOLS
Caution or Warning, see product instructions.
Consult product instructions.
The lot in a box represents the lot number.
The hourglass is followed by a month and year which represent the expiration date.
Store between given temperatures.
AOAC is a registered trademark of AOAC INTERNATIONAL
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