AOAC-RI ERP Micro June 2016

OMAMAN-29/OMAMAN-30 Combined Collaborative Study Protocol OMA ERP - June 2016 ERP Use Only

Lysis Solution (LS) tubes

Pink solution in clear tubes

Racked and ready to use

96 (12 strips of 8 tubes) 580 µ L of LS per tube

Lyophilized specific amplification and detection mix Lyophilized control DNA, amplification and detection mix

Listeria Reagent tubes Blue tubes

96 (12 strips of 8 tubes)

Ready to use

Extra caps

Blue caps

96 (12 strips of 8 caps)

Ready to use

Clear flip-top tubes

16 (2 pouches of 8 individual tubes)

Reagent Control (RC)

Ready to use

Quick Start Guide

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1 The Negative Control, not provided in the kit, is sterile enrichment medium, e.g., Demi-Fraser 2 Broth. Do not use water as a Negative Control. 5 The user should read, understand and follow all safety information in the instructions for the 3M 6 Molecular Detection System and the 3M Molecular Detection Assay 2 - Listeria. Retain the 7 safety instructions for future reference. 3 4 SAFETY

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Indicates a hazardous situation, which, if not avoided, could result in death or serious injury and/or property damage.

WARNING:

Indicates a hazardous situation, which, if not avoided, could result in minor or moderate injury and/or property damage.

CAUTION:

NOTICE: Indicates a potentially hazardous situation which, if not avoided, could result in property damage. AOAC Research Institute Expert Review Panel Use Only WARNING Do not use the 3M Molecular Detection Assay 2 - Listeria in the diagnosis of conditions in 11 humans or animals. 12 13 The 3M Molecular Detection Assay 2 - Listeria method may generate Listeria monocytogenes to 14 levels sufficient to cause stillbirths and fatalities in pregnant women and the immuno 15 compromised, if exposed. 16 10

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