350 / 596
12
4.7
Transfer
20 µL of NC lysate into a RC tube
. Dispense at an angle to avoid disturbing
1
the pellets. Mix by gently pipetting up and down 5 times.
2
5.
Load capped tubes into a clean and decontaminated 3M Molecular Detection Speed Loader
3
Tray. See illustration below. Close and latch the 3M Molecular Detection Speed Loader Tray
4
lid.
5
6
7
8
6.
Review and confirm the configured run in the 3M Molecular Detection Software.
9
7.
Click the Start button in the software and select instrument for use. The selected instrument’s
10
lid automatically opens.
11
8.
Place the 3M Molecular Detection Speed Loader Tray into the 3M MDS Instrument and
12
close the lid to start the assay. Results are provided within 75minutes, although positives may
13
be detected sooner.
14
9.
After the assay is complete, remove the 3M Molecular Detection Speed Loader Tray from
15
the 3M Molecular Detection Instrument and dispose of the tubes by soaking in a 1-5% (v:v in
16
water) household bleach solution for 1 hour and away from the assay preparation area.
17
18
NOTICE:
To minimize the risk of false positives due to cross-contamination, never open reagent tubes
19
containing amplified DNA. This includes Reagent Control, Reagent and Matrix Control tubes. Always
20
dispose of sealed reagent tubes by soaking in a 1-5% (v:v in water) household bleach solution for 1 hour
21
and away from the assay preparation area.
22
23
R
ESULTS AND
I
NTERPRETATION
24
An algorithm interprets the light output curve resulting from the detection of the nucleic acid
25
amplification. Results are analyzed automatically by the software and are color-coded based on
26
the result. A Positive or Negative result is determined by analysis of a number of unique curve
27
parameters. Presumptive positive results are reported in real-time while Negative and Inspect
28
results will be displayed after the run is completed.
29
30
Presumptive positive samples should be confirmed as per the laboratory standard operating
31
procedures or by following the current version of the appropriate reference method
32
confirmation
.
( FDA/BAM ,the
USDA/FSIS-MLG), beginning with transfer from the primary
33
enrichment to secondary enrichment broth (if applicable), followed by subsequent plating and
34
confirmation of isolates using appropriate biochemical and serological methods.
35
36
NOTE:
Even a negative sample will not give a zero reading as the system and 3M Molecular
37
Detection Assay 2 -
Listeria
amplificationreagents have a “background” relative light unit (RLU)
38
reading.
39
40
Formatted:
Left