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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
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lid automatically opens.
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8.
Place the 3M Molecular Detection Speed Loader Tray into the 3M MDS Instrument and
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close the lid to start the assay. Results are provided within 75minutes, although positives may
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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
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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
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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
amplificationreagents have a “background” relative light unit (RLU)
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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
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Inspect, proceed to confirmation test using your preferred method or as specified by local
38
regulations.
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AOAC Research Institute
Expert Review Panel Use Only
OMAMAN-29 A/ Collaboartive Study Manuscript
OMA ERP June 2016
ERP Use Only