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Table 1. Kit Components
1
2
Item
Identification
Quantity
Contents
Comments
Lysis Solution (LS)
tubes
Pink solution
in clear tubes
96 (12 strips of 8 tubes) 580
µ
L of LS per tube
Racked and
ready to use
Listeria
monocytogenes
Reagent
tubes
Yellow tubes
96 (12 strips of 8 tubes)
Lyophilized specific
amplification and
detection mix
Ready to use
Extra caps
Yellow caps
96 (12 strips of 8 caps)
Ready to use
Reagent Control (RC)
Clear flip-top
tubes
16 (2 pouches of 8
individual tubes)
Lyophilized control
DNA, amplification
and detection mix
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.
6
7
SAFETY
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.
11
12
WARNING:
Indicates a hazardous situation, which, if not avoided, could result
in death or serious injury and/or property damage.
CAUTION:
Indicates a hazardous situation, which, if not avoided, could result
in minor or moderate injury and/or property damage.
NOTICE:
Indicates a potentially hazardous situation which, if not avoided,
could result in property damage.
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
AOAC Research Institute
Expert Review Panel Use Only
OMAMAN-29/OMAMAN-30 Combined Collaborative Study Protocol
OMA ERP - June 2016
ERP Use Only