Product Description And Intended Use - 3M E. coli O157 Gebrauchsanweisungen

3
Molecular Detection Assay 2 - E. coli O157 (including H7)

Product Description and Intended Use

The 3M™ Molecular Detection Assay 2 - E. coli O157 (including H7) is used with the 3M™ Molecular Detection System for
the rapid and specific detection of E. coli O157 (including H7) in enriched food and feed samples.
The 3M Molecular Detection Assays use loop-mediated isothermal amplification to rapidly amplify nucleic acid sequences
with high specificity and sensitivity, combined with bioluminescence to detect the amplification. Presumptive positive
results are reported in real-time while negative results are displayed after the assay is completed. Presumptive positive
results should be confirmed using your preferred method or as specified by local regulations
The 3M Molecular Detection Assay 2 - E. coli O157 (including H7) is intended for use in a laboratory environment by
professionals trained in laboratory techniques. 3M has not documented the use of this product in industries other than food
or beverage. For example, 3M has not documented this product for testing environmental, pharmaceutical, cosmetics,
clinical or veterinary samples. The 3M Molecular Detection Assay 2 - E. coli O157 (including H7) has not been evaluated
with all possible food products, food processes, testing protocols or with all possible strains of bacteria.
As with all test methods, the source, formulation and quality of enrichment medium can influence the results.
Factors such as sampling methods, testing protocols, sample preparation, handling, and laboratory technique may also
influence results. 3M recommends evaluation of the method including enrichment medium, in the user's environment
using a sufficient number of samples with particular foods and microbial challenges to ensure that the method meets the
user's criteria.
3M has evaluated the 3M Molecular Detection Assay 2 - E. coli O157 (including H7) with Buffered Peptone Water ISO.
The 3M™ Molecular Detection Instrument is intended for use with samples that have undergone heat treatment during
the assay lysis step, which is designed to destroy organisms present in the sample. 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.
3M Food Safety is certified to ISO (International Organization for Standardization) 9001 for design and manufacturing.
The 3M Molecular Detection Assay 2 - E. coli O157 (including H7) test kit contains 96 tests, described in Table 1.
Table 1. 3M Molecular Detection Assay Kit Components
Item
3M™ Lysis Solution (LS)
3M™ Molecular Detection
Assay 2 - E. coli O157
(including H7) Reagent
Tubes
Extra caps
3M™ Reagent Control
(RC)
Quick Start Guide
The Negative Control, not provided in the kit, is a sterile enrichment medium, e.g., BPW ISO. 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 - E. coli O157 (including H7). 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.
NOTICE: Indicates a potentially hazardous situation which, if not avoided, could result in property damage.
Identification Quantity
Pink solution in
96 (12 strips of 8 tubes)
clear tubes
Pink tubes 96 (12 strips of 8 tubes)
Pink caps 96 (12 strips of 8 caps)
Clear flip-top 16 (2 pouches of 8
tubes individual tubes)
1
Product Instructions
Contents
580 μL of 3M Lysis Solution
per tube
Lyophilized specific
amplification and detection mix
Lyophilized control DNA,
amplification and detection mix
1
(English)
Issue Date: 2017-07
.
(1, 2, 3)
Comments
Racked and
ready to use
Ready to use
Ready to use
Ready to use