3M Molecular Detection Assay 2 Manuel D'instructions page 3

Table 1. Kit Components
Item Identification
Lysis Solution Pink solution in clear
(LS) tubes tubes
Listeria Reagent tubes Blue tubes
Extra caps Blue caps
Reagent Control (RC) Clear flip-top tubes
Quick Start Guide
The Negative Control, not provided in the kit, is sterile enrichment medium, e.g., Demi-Fraser Broth. Do not use water as a
Negative Control.
Safety
The user should read, understand and follow all safety information in the instructions for the 3M Molecular Detection
System and the 3M Molecular Detection Assay 2 - Listeria. Retain the safety instructions for future reference.
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.
Do not use the 3M Molecular Detection Assay 2 - Listeria in the diagnosis of conditions in humans or animals.
The 3M Molecular Detection Assay 2 - Listeria method may generate Listeria monocytogenes to levels sufficient to
cause stillbirths and fatalities in pregnant women and the immunocompromised, if exposed.
The user must train its personnel in current proper testing techniques: for example, Good Laboratory Practices, ISO/
IEC 17025 , or ISO 7218
(4) (5)
To reduce the risks associated with a false-negative result leading to the release of contaminated product:
• Follow the protocol and perform the tests exactly as stated in the product instructions.
• Store the 3M Molecular Detection Assay 2 - Listeria as indicated on the package and in the product instructions.
• Always use the 3M Molecular Detection Assay 2 - Listeria by the expiration date.
• Use the 3M Molecular Detection Assay 2 - Listeria for food and environmental samples that have been validated
internally or by a third party.
• Use the 3M Molecular Detection Assay 2 - Listeria only for surfaces, sanitizers, protocols and bacterial strains that have
been validated internally or by a third party.
• For an environmental sample containing Neutralizing Buffer with aryl sulfonate complex, perform a 1:2 dilution before
testing (1 part sample into 1 part sterile enrichment broth). Another option is to transfer 10 μL of the NB enrichment
into the LS tubes. 3M™ sample handling products which include Neutralizing Buffer with aryl sulfonate complex:
BPPFV10NB, RS96010NB, RS9604NB, SSL10NB, XSLSSL10NB, HS10NB and HS119510NB.
To reduce the risks associated with exposure to chemicals and biohazards:
• It is strongly recommended that female laboratory staff be informed of the risk to a developing fetus resulting from
infection of the mother through exposure to Listeria monocytogenes.
• Perform pathogen testing in a properly equipped laboratory under the control of trained personnel.
• Always follow standard laboratory safety practices, including wearing appropriate protective apparel and eye
protection while handling reagents and contaminated samples.
• Avoid contact with the contents of the enrichment media and reagent tubes after amplification.
• Dispose of enriched samples according to current local/regional/national regulation and industry standards.
• Samples that have not been properly heat treated during the assay lysis step may be considered a potential biohazard
and should NOT be inserted into the 3M Molecular Detection Instrument.
To reduce the risks associated with cross-contamination while preparing the assay:
• Always wear gloves (to protect the user and prevent introduction of nucleases).
Quantity
96
(12 strips of 8 tubes)
96
(12 strips of 8 tubes)
96 (12 strips of 8 caps)
16 (2 pouches of
8 individual tubes)
1
.
Contents
580 μL of LS per tube
Lyophilized specific
amplification and
detection mix
Lyophilized control
DNA, amplification
and detection mix
W WARNING
3
EN (English)
Comments
Racked and
ready to use
Ready to use
Ready to use
Ready to use