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6.
Review and confirm the configured run in the 3M Molecular Detection Software.
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7.
Click the Start button in the software and select instrument for use. The selected instrument’s
2
lid automatically opens.
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8.
Place the 3M Molecular Detection Speed Loader Tray into the 3M MDS Instrument and
4
close the lid to start the assay. Results are provided within 75minutes, although positives may
5
be detected sooner.
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9.
After the assay is complete, remove the 3M Molecular Detection Speed Loader Tray from
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the 3M Molecular Detection Instrument and dispose of the tubes by soaking in a 1-5% (v:v in
8
water) household bleach solution for 1 hour and away from the assay preparation area.
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NOTICE:
To minimize the risk of false positives due to cross-contamination, never open reagent tubes
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containing amplified DNA. This includes Reagent Control, Reagent and Matrix Control tubes. Always
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dispose of sealed reagent tubes by soaking in a 1-5% (v:v in water) household bleach solution for 1 hour
13
and away from the assay preparation area.
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R
ESULTS AND
I
NTERPRETATION
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An algorithm interprets the light output curve resulting from the detection of the nucleic acid
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amplification. Results are analyzed automatically by the software and are color-coded based on
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the result. A Positive or Negative result is determined by analysis of a number of unique curve
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parameters. Presumptive positive results are reported in real-time while Negative and Inspect
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results will be displayed after the run is completed.
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Presumptive positive samples should be confirmed as per the laboratory standard operating
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procedures or by following the current version of the appropriate reference method
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confirmation
.
( FDA/BAM ,the
USDA/FSIS-MLG), beginning with transfer from the primary
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enrichment to secondary enrichment broth (if applicable), followed by subsequent plating and
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confirmation of isolates using appropriate biochemical and serological methods.
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NOTE:
Even a negative sample will not give a zero reading as the system and 3M Molecular
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Detection Assay 2 -
Listeria monocytogenes
amplificationreagents have a “background” relative
30
light unit (RLU) reading.
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In the rare event of any unusual light output, the algorithm labels this as “Inspect.” 3M
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recommends the user to repeat the assay for any Inspect samples. If the result continues to be
34
Inspect, proceed to confirmation test using your preferred method or as specified by local
35
regulations.
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Results of Collaborative Study
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For this collaborative study, the 3M Molecular Detection Assay (MDA) 2 -
Listeria
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monocytogenes
method was compared to the USDA FSIS MLG 8.09 reference method for deli
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turkey and raw chicken breast fillet. A total of 13 laboratories throughout the United Statesand
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Canada participated in this study, with 11 laboratories submitting data for the deli turkey and 12
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laboratories submitting data for the raw chicken breast fillet. See Table 1 for a summary of
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laboratory participation for each matrix. Each laboratory analyzed 36 test portions for each
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AOAC Research Institute
Expert Review Panel Use Only
OMAMAN-30 A/ Collaborative Study Manuscript
OMA ERP June 2016
ERP Use Only