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16.

Load capped tubes into a clean and decontaminated 3M Molecular Detection Speed Loader

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Tray. Close and latch the 3M Molecular Detection Speed Loader Tray lid.

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5

6

7

17.

Review and confirm the configured run in the 3M Molecular Detection Software.

8

18.

Click the Start button in the software and select instrument for use. The selected

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instrument’s lid automatically opens.

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19.

Place the 3M Molecular Detection Speed Loader Tray into the 3M Molecular Detection

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Instrument and close the lid to start the assay. Results are provided within 75 minutes,

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although positives may be detected sooner.

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20.

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

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tubes containing amplified DNA. This includes Reagent Control, Reagent, and Matrix Control

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tubes. Always dispose of sealed reagent tubes by soaking in a 1-5% (v:v in water) household

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bleach solution for 1 hour 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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AO C Research Institute

Expert Review Panel Use Only

OMAMAN-29/OMAMAN-30 Combined Collaborative Study Protocol

OMA ERP - June 2016

ERP Use Only