3M E. coli O157 Gebrauchsanweisungen Seite 3

Do not use the 3M Molecular Detection Assay 2 - E. coli O157 (including H7) in the diagnosis of conditions in
humans or animals.
The user must train its personnel in current proper testing techniques: for example, Good Laboratory Practices,
ISO/IEC 17025 , or ISO 7218
(4)
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.
• Use medium pre-warmed to 41.5 ± 1°C. Do not allow the medium to drop below the incubation temperature range
during sample preparation.
• Store the 3M Molecular Detection Assay 2 - E. coli O157 (including H7) as indicated on the package and in the
product instructions.
• Always use the 3M Molecular Detection Assay 2 - E. coli O157 (including H7) by the expiration date.
• Use the 3M Molecular Detection Assay 2 - E. coli O157 (including H7) with food, feed and food process environmental
samples that have been validated internally or by a third party.
• Use the 3M Molecular Detection Assay 2 - E. coli O157 (including H7) only with surfaces, sanitizers, protocols and
bacterial strains that have been validated internally or by a third party.
• For an environmental sample containing Neutralizing Buffer (NB) 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 neutralizing
buffer enrichment into the 3M Lysis Solution tubes. 3M™ Sample Handling products which include 3M™ 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:
• Perform pathogen testing in a properly equipped laboratory under the control of trained personnel. Incubated
enrichment media and equipment or surfaces that have come into contact with incubated enrichment media may
contain pathogens at levels sufficient to cause risk to human health.
• 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 and associated contaminated waste according to current local/regional/national/
industry standards.
• 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 or 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.
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 exposure to hot liquids:
• 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 or 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.
To reduce the risks associated with cross-contamination while preparing the assay:
• Use of sterile, aerosol barrier (filtered), molecular biology grade pipette tips is recommended.
• Use a new pipette tip for each sample transfer.
• Use Good Laboratory Practices to transfer the sample from the enrichment to the lysis tube. To avoid pipettor
contamination, the user may choose to add an intermediate transfer step. For example, the user can transfer each
enriched sample into a sterile tube.
• Use a molecular biology workstation containing germicidal lamp where available.
To reduce the risks associated with a false-positive result:
• Never open tubes post amplification.
• Always dispose of the contaminated tubes by soaking in a 1-5% (v:v in water) household bleach solution for 1 hour and
away from the assay preparation area.
Consult the Safety Data Sheet for additional information and local regulations for disposal.
If you have questions about specific applications or procedures, please visit our website at www.3M.com/foodsafety or
contact your local 3M representative or distributor.
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