AOAC-RI ERP Micro June 2016

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

Table 1. Kit Components

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Item

Identification Pink solution in clear tubes

Quantity

Contents

Comments Racked and ready to use

Lysis Solution (LS) tubes

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

Listeria monocytogenes Reagent tubes

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

Yellow tubes

96 (12 strips of 8 tubes)

Ready to use

Extra caps

Yellow 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

1

3 4 The Negative Control, not provided in the kit, is sterile enrichment medium, e.g., Demi-Fraser 5 Broth. Do not use water as a Negative Control. 8 The user should read, understand and follow all safety information in the instructions for the 3M 9 Molecular Detection System and the 3M Molecular Detection Assay 2 - Listeria monocytogenes . 10 Retain the safety instructions for future reference. 6 7 SAFETY

11 12

Indicates a hazardous situation, which, if not avoided, could result in death or serious injury and/or property damage. AOAC Research Institute Expert Review Panel Use Only Indicates a hazardous situation, which, if not avoided, could result in minor or moderate injury and/or property damage. Indicates a potentially hazardous situation which, if not avoided, could result in property damage.

WARNING:

CAUTION:

NOTICE:

13

WARNING

14 Do not use the 3M Molecular Detection Assay 2 - Listeria monocytogenes in the diagnosis of 15 conditions in humans or animals. 16

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