AOAC-RI ERP Micro June 2016

OMAMAN-29 A/ Collaboartive Study Manuscript OMA ERP June 2016 ERP Use Only

1 2 3 6. Review and confirm the configured run in the 3M Molecular Detection Software. 4 7. Click the Start button in the software and select instrument for use. The selected instrument’s 5 lid automatically opens. 6 8. Place the 3M Molecular Detection Speed Loader Tray into the 3M MDS Instrument and 7 close the lid to start the assay. Results are provided within 75minutes, although positives may 8 be detected sooner. 9 9. After the assay is complete, remove the 3M Molecular Detection Speed Loader Tray from 10 the 3M Molecular Detection Instrument and dispose of the tubes by soaking in a 1-5% (v:v in 11 water) household bleach solution for 1 hour and away from the assay preparation area. 12 13 NOTICE: To minimize the risk of false positives due to cross-contamination, never open reagent tubes 14 containing amplified DNA. This includes Reagent Control, Reagent and Matrix Control tubes. Always 15 dispose of sealed reagent tubes by soaking in a 1-5% (v:v in water) household bleach solution for 1 hour 16 and away from the assay preparation area. 19 An algorithm interprets the light output curve resulting from the detection of the nucleic acid 20 amplification. Results are analyzed automatically by the software and are color-coded based on 21 the result. A Positive or Negative result is determined by analysis of a number of unique curve 22 parameters. Presumptive positive results are reported in real-time while Negative and Inspect 23 results will be displayed after the run is completed. 24 25 Presumptive positive samples should be confirmed as per the laboratory standard operating 26 procedures or by following the current version of the appropriate reference method 27 confirmation . ( FDA/BAM , the USDA/FSIS-MLG) , beginning with transfer from the primary 28 enrichment to secondary enrichment broth (if applicable), followed by subsequent plating and 29 confirmation of isolates using appropriate biochemical and serological methods. 30 31 NOTE: Even a negative sample will not give a zero reading as the system and 3M Molecular 32 Detection Assay 2 - Listeria amplificationreagents have a “background” relative light unit (RLU) 33 reading. 34 35 In the rare event of any unusual light output, the algorithm labels this as “Inspect.” 3M 36 recommends the user to repeat the assay for any Inspect samples. If the result continues to be 37 Inspect, proceed to confirmation test using your preferred method or as specified by local 38 regulations. AOAC Research Institute Expert Review Panel Use Only 17 18 R ESULTS AND I NTERPRETATION

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