3M Listeria MDAL96 Manual Del Usuario página 3

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 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 Listeria in the diagnosis of conditions in humans or animals.
The 3M Molecular Detection Assay 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 17025
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 Listeria as indicated on the package and in the product instructions.
• Always use the 3M Molecular Detection Assay Listeria by the expiration date.
• Do not use Demi-Fraser Broth Base or Fraser Broth Base containing ferric ammonium citrate (FAC), either already in the broth base or as an added
supplement, when using the 3M Molecular Detection Assay Listeria.
• Use the 3M Molecular Detection Assay Listeria for food and environmental samples that have been validated internally or by a third party.
• Use the 3M Molecular Detection Assay Listeria only for surfaces, sanitizers, protocols and bacterial strains that have been validated internally or by
a third party.
• Use care when pipetting lysate, as carry-over of the resin may interfere with the amplification.
• 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). 3M™ sample handling products which include neutralizing buffer: 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 industry standards.
To reduce the risks associated with cross-contamination while preparing the assay:
• Always wear gloves (to protect the user and prevent introduction of nucleases).
To reduce the risks associated with environmental contamination:
• Follow current industry standards for disposal of contaminated waste.
To avoid dislodging of the lysis tube caps during the lysis heating step which could cause exposure to hot liquids or cross-contamination:
• Do not invert the lysis tubes after heating and before chilling.
• Ensure all caps are tightly sealed using the 3M™ Molecular Detection Cap/Decap Tool – Lysis.
• Do not exceed the recommended temperature setting on heater.
• Do not exceed the recommended heating time.
• Use an appropriate, calibrated thermometer to verify the 3M™ Molecular Detection Heat Block Insert temperature (e.g., a partial immersion
thermometer, digital thermocouple thermometer, not a total immersion thermometer). The thermometer must be placed in the designated location
in the 3M Molecular Detection Heat Block Insert.
W WARNING
CAUTION
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, or ISO 7218 .
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