3M MDA2CAM96 Mode D'emploi page 10

9. Place the 3M Molecular Detection Speed Loader Tray into the 3M Molecular Detection Instrument and close the lid to
start the assay. Results are provided within 60 minutes, although positives may be detected sooner.
10. After the assay is complete, remove the 3M Molecular Detection Speed Loader Tray from the 3M Molecular Detection
Instrument and dispose of the tubes by soaking in a 1-5% (v:v in water) household bleach solution for 1 hour and away
from the assay preparation area.
NOTICE: To minimize the risk of false positives due to cross-contamination, never open reagent tubes containing
amplified DNA. This includes 3M Molecular Detection Assay 2 - Campylobacter Reagent, 3M Reagent Control, and
3M Matrix Control Tubes. Always dispose of sealed reagent tubes by soaking in a 1 - 5% (v:v in water) household bleach
solution for 1 hour and away from the assay preparation area.
Results and Interpretation
An algorithm interprets the light output curve resulting from the detection of the nucleic acid amplification. Results are
analysed automatically by the software and are color-coded based on the result. A Positive or Negative result is determined
by analysis of a number of unique curve parameters. Presumptive Positive results are reported in real-time while Negative
and Inspect results will be displayed after the run is completed.
Presumptive positive samples should be confirmed as per the laboratory standard operating procedures or by following the
appropriate reference method confirmation
Broth enrichment to selective Campylobacter plates with microaerophilic incubation, confirmation of isolates using
appropriate biochemical, microscopic and serological methods. For the best maintenance of the enrichment, roll down the
enrichment bag after collecting a sample.
NOTE: Even a negative sample will not give a zero reading as the system and 3M Molecular Detection Assay 2 -
Campylobacter amplification reagents have a "background" relative light unit (RLU) reading.
In the rare event of any unusual light output, the algorithm labels this as Inspect. 3M recommends the user to repeat the
assay for any Inspect samples. If the result continues to be Inspect, proceed to confirmation test using your preferred
method or as specified by local regulations
Appendix A. Protocol Interruption: Storage and re-testing of heat-treated lysates
1. To store a heat-treated lysate, re-cap the 3M Lysis Solution Tube with a clean cap (see Lysis section, 4.5)
2. Store at 2 to 8°C for up to 72 hours.
3. Prepare a stored sample for amplification by inverting 2-3 times to mix.
4. Decap the tubes.
5. Place the mixed lysate tubes on 3M Molecular Detection Heat Block Insert and heat at 100 ± 1°C for 5 ± 1 minutes.
6. Remove the rack of 3M Lysis Solution tubes from the 3M Molecular Detection Heat Block and allow to cool in the 3M
Molecular Detection Chill Block Insert at least 5 minutes and a maximum of 10 minutes.
Continue the protocol at the Amplification section detailed above.
7.
References:
1. Microbiology Laboratory Guidebook. U. S. Department of Agriculture (USDA) Food Safety and Inspection Service
(FSIS) Microbiology Laboratory guidebook 41.04. Isolation and identification of Campylobacter jejuni/coli/lari from
poultry rinse, sponge and raw product samples. August 1, 2016.
2. ISO 10272-1. Microbiology of the food chain - Horizontal method for detection and enumeration of Campylobacter
spp. Part 1. Detection method.
3. U.S. Food and Drug Administration. Code of Federal Regulations, Title 21, Part 58. Good Laboratory Practice for
Nonclinical Laboratory Studies.
4. ISO/IEC 17025. General requirements for the competence of testing and calibration laboratories.
5. ISO 7218. Microbiology of food and animal feeding stuffs - General rules for microbiological examination.
6. 3M Installation Qualification (IQ) / Operational Qualification (OQ) Protocols and Instructions for 3M Molecular
Detection System. Contact your 3M Food Safety representative to obtain a copy of this document.
7. ISO 11133. Microbiology of food, animal feed and water - Preparation, production, storage and performance testing of
culture media.
8. U. S. Department of Agriculture (USDA). Food Safety and Inspection Service (FSIS) Directive 10, 250.1. Salmonella and
Campylobacter verification program for raw meat and poultry products. September 20, 2013.
Explanation of Symbols
www.3M.com/foodsafety/symbols
, beginning with transfer from the primary 3M Campylobacter Enrichment
(1,2)
.
(1,2)
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