FoodChek™ - Listeria spp.
Contents
1. Interpretation of Test Results and Report 1 Results Output The results are indicated on both the instrument LCD display and the instrument printout These results are reported as being either Positive or Negative If an Invalid or Indeterminate result is obtained see FoodChek Instrument User Manual for further instructions troubleshooting 2 Negative Result A negative result should be interpreted as the sample NOT being contaminated with either L monocytogenes L innocua L ivanovii L seeligeri or L welshimeri 3 Positive Result A positive result should be interpreted as the sample being possibly contaminated with either L monocytogenes L innocua L ivanovii L seeligeri or L welshimeri Confirmation of Positive Results Since FoodChek Listeria spp assay is a screening test for Listeria spp all positive samples should be culturally confirmed according to the U S Food and Drug Administration Bacteriological Analytical Manual Chapter 10 Detection and Enumeration of Listeria monocytogenes 2011 or in the FSIS Microbiology Laboratory Guidebook Chapter 8 09 2013 Product Storage and Shelf Life The FoodChek Listeria spp assay should be stored at the temperature 2 8 C The expiry date is indicated on the box FoodChek Listeria spp Package Insert FCLS 003 Page 6 of 8 Suite 450 1414 8 St S W P 403 269 9424 FoodChex Calgary Alberta T2R 1J6 F 403 263 6357 Ww Food safety2. applicable on the date of delivery FoodChek Systems Inc s sole obligation under this warranty shall be to replace or repair the defective product or part for any defect found to have occurred under normal use during the one 1 year period This warranty does not cover replacement of products damaged due to misuse abuse alteration self repair loss or theft Catalogue Number FCLS 003 FoodChek Listeria spp Assay Cassettes FoodChek Listeria spp Package Insert FCLS 003 Page 7 of 8 Suite 450 1414 8 St S W P 403 269 9424 FoodChexw Calgary Alberta T2R 1J6 F 403 263 6357 YW Food safety simplified Canada www foodcheksystems com e For further information please contact FoodChek Systems Inc Suite 450 1414 8 St S W Calgary Alberta Canada T2R 1J6 Tel 1 877 298 0208 FoodChewx Food safety simplified PERFORMANCE TESTED AOAC RESEARCH INSTITUTE LICENSE NUMBER 111202 FoodChek Listeria spp Package Insert FCLS 003 Page 8 of 8
3. for accurate results Frozen Cooked Shrimps and Fresh Soft Cheese Ricotta 25 g 1 Pre warm the prepared Actero Listeria Enrichment Media at 32 C 2 Add 150 mL of the pre warmed Actero Listeria Enrichment Media to each 25 g frozen cooked shrimps sample in a filtered stomacher sample bag 3 Stomach the sample for 2 minutes at 175 rpm in a Stomacher 400 circulator 4 For the enrichment phase close the bags and incubate the samples in an incubator for 28h at 32 0 5 C Adherence to temperature is important for accurate results Analysis of Samples Using FoodChek Listeria spp Cassettes cat FCLS 003 1 9 Turn on the FoodChek MICT Reader Initialization will take a few minutes When the instrument is ready for use the screen will show four pictograms Select the pictogram representing a cassette by touching the screen Allow the required number of the FoodChek Listeria spp cassettes to equilibrate to room temperature prior to use at least 30 minutes One cassette per sample is required Following the enrichment for each sample label a 15 mL tube place it in a tube rack and remove the cap of the tube Mix the sample thoroughly and transfer 5 0 2 mL of the enriched culture sample from the bag to the tube Cap the tube Keep the sample bag for cultural confirmation of any positive result obtained with FoodChek Listeria spp assay Using a boiling water bath 100 C h
4. simplified Canada www foodcheksystems com od Disposal Dispose all materials used and the enrichment media by autoclaving or according to an approved practice Ensure that all bio hazardous waste is disposed of according to local municipal provincial state and or federal regulations Precautions Biosafety level 2 procedures should be exercised BMBL http www cdc gov biosafety publications bmbl5 bmbl pdf Extreme care should be taken in handling test samples and enrichment broths All enrichment broths may contain various pathogens whether they contain Listeria spp or not Terms and Conditions FoodChek Systems Inc makes no representations and warranties concerning its products other than those stated herein All Product s delivered hereunder by FoodChek Systems Inc its affiliates or any other person on its behalf shall at the time of delivery be manufactured to meet FoodChek Systems Inc s specifications and all applicable laws All other terms conditions and warranties including any warranty of merchantability quality fitness or suitability for a particular or intended purpose implied by common law or statue implied warranties are expressly excluded FoodChek Systems Inc warrants its new equipment to the original Customer only for a period of one 1 year after date of delivery against defects in material and workmanship and defects arising from failure to conform to FoodChek Systems Inc s specifications
5. Suite 450 1414 8 St S W P 403 269 9424 FoodCher Calgary Alberta T2R 1J6 F 403 263 6357 y Rod ean simplified Canada www foodcheksystems com FoodChek Listeria spp Assay Cassettes Product Information Intended Use The FoodChek Listeria spp is a lateral flow immunonanomagnetic screening assay for the rapid detection of Listeria spp from environmental and food samples The assay was validated according to the Performance Tested Methods of the AOAC The test detects with high efficiency L monocytogenes L innocua L ivanovii L seeligeri and L welchimert L grayi is not detected The assay cassette a lateral flow separation device that has the testing sample loaded into the sample port of the cassette that is then allowed to laterally flow in the device followed by analysis in the MICT FoodChek Reader The cassette has a printed label attached that contains written and bar coded identity information the expiry date and the required values for automated analysis by the FoodChek Reader cat FCR 004 Principle of Operation The cassette is composed of a conjugate pad that contains nano sized magnetic particles conjugated to a specific antibody that will bind the complimentary antigen The test comprises a second antibody in a narrow strip called the capture zone Capillary flow moves the loaded sample through the sample pad onto the conjugate pad where the target bacteria will bind to the antib
6. able from FoodChek Systems Inc Additional Materials Required All Samples 1 Actero Listeria Enrichment Media is available from FoodChek Systems Inc in several formats a box of 20 individual packs of 4 9 g of powder each one cat FCM 007 a bottle of 500 g cat FCM 011 and 1 L polycarbonate bottle of prepared medium cat FCM 024 FoodChek MICT v2 Reader cat FCR 004 available from FoodChek Systems Inc Sterile stomacher bags with and without filter Stomacher Vortex Distilled deionized water Incubator at 29 0 5 C or 32 0 5 C Graduated cylinder with a capacity of 100 mL 200 mL and 1L Oo ON WDB OT FP W LN Polypropylene tube with cap Any source 10 Disposable transfer pipettes Any source 11 Micropipette able to dispense 150 uL 12 Pipette tips fitting with the micropipette Any source 13 Water bath able to provide 100 C to boil the enriched samples 14 Regular laboratory equipment is also required Environmental Surfaces 1 Non bactericidal 8X4x0 3 cm sterile cellulose sampling sponges pre moistened with neutralizing Dey Engley D E buffer cat FCLS 002 available from FoodChek Systems Inc FoodChek Listeria spp Package Insert FCLS 003 Page 2 of 8 Suite 450 1414 8 St S W P 403 269 9424 FoodChex Calgary Alberta T2R 1J6 F 403 263 6357 Food safety simplified Canada www foodcheksystems com Procedure Pre
7. eat treat the tube of 5 mL of enriched sample for 15 minutes Allow the sample to cool down to room temperature Ensure that each heat treated sample is cooled down to room temperature before proceeding to the test When the samples are cooled down mix each of them thoroughly using a vortex and a micropipette When processing a large number of samples proceed per batches of 10 cassettes 10 Using a micropipette transfer 150 uL of the heat treated sample cooled directly into the sample port of the FoodChek Listeria spp cassette Change pipette tips between each FoodChek Listeria spp Package Insert FCLS 003 Page 5 of 8 7 Suite 450 1414 8 St S W P 403 269 9424 FoodChex Calgary Alberta T2R 1J6 F 403 263 6357 Ww Food safety simplified Canada www foodcheksystems com od sample When testing heavily coagulated heat treated samples use wide bore micropipette tips to facilitate the pipetting 11 Allow the assay to develop for 30 minutes at room temperature before reading in the FoodChek MICT Reader Note that interpreting results before 25 minutes or after 35 minutes may lead to inaccurate results 12 Open the front door of the reader and insert the cassette Ensure that the barcode is on the up side Close the door of the reader Closing the reader door will initiate the reading process 13 The reader will generate an output on the LCD screen as well as a printed result on paper tape
8. in the sealed bag for approximately one minute For the enrichment phase close the bags and incubate the samples in an incubator for 28h at 32 0 5 C Adherence to temperature is important for accurate results Food Sample Preparation Liquid Whole Eggs 25 g 1 2 Pre warm the prepared Actero Listeria Enrichment Media at 32 C Add 150 mL of the pre warmed Actero Listeria Enrichment Media to each 25 g liquid whole eggs sample in a non filtered stomacher sample bag Stomach the sample for 30 seconds at 90 rpm in a Stomacher 400 circulator For the enrichment phase close the bags and incubate the samples in an incubator for 28h at 32 0 5 C Adherence to temperature is important for accurate results Cold Smoked Salmon 25 g 1 2 3 Pre warm the prepared Actero Listeria Enrichment Media at 29 C Add 150 mL of the pre warmed Actero Listeria Enrichment Media to each 25 g cold smoked salmon sample in a filtered stomacher sample bag Stomach the sample for 2 minutes at 175 rpm in a Stomacher 400 circulator FoodChek Listeria spp Package Insert FCLS 003 Page 4 of 8 7 Suite 450 1414 8 St S W P 403 269 9424 FoodChex Calgary Alberta T2R 1J6 F 403 263 6357 Food safety simplified Canada www foodcheksystems com 4 For the enrichment phase close the bags and incubate the samples in an incubator for 28h at 29 0 5 C Adherence to temperature is important
9. ody coated particles This antigen antibody immune complex now flows onto the test strip to the capture zone The result is an accumulation of specific magnetic particles in the capture zone If the target pathogen is absent immune complexes do not form and particles do not accumulate at the capture line and the test result is negative Further downstream a Control Line that has been placed in a strip format but with different reagents acts to verify that the test has performed correctly The cassette is read in an instrument the MICT FoodChek Reader that is capable of detecting very low concentrations of magnetic particles The instrument compares the detection signal with a positive threshold value encoded in a barcode on the individual cassette and then reports a positive or negative result The results are displayed on the instrument s liquid crystal display LCD screen and printed In addition to all analysis parameters the barcode also encodes the test name lot number and expiry date that are printed along with the test result FoodChek Listeria spp Package Insert FCLS 003 Page 1 of 8 Suite 450 1414 8 St S W P 403 269 9424 FoodChex Calgary Alberta T2R 1J6 F 403 263 6357 Ww Food safety simplified Canada www foodcheksystems com od Contents FoodChek Listeria spp Assay Cassettes cat FCLS 003 comprising a pack of 20 assay cassettes intended for 20 independent analytical procedures Avail
10. paration of Samples for Testing with FoodChek Listeria spp Cassettes NOTE The sample preparation depends on the type and size of the sample Thus the protocol to prepare the sample should be chosen in function of those conditions However all the other steps are the same Enrichment Media Preparation 1 Prepare the Actero Listeria Enrichment Media following the manufacturer instruction Environmental Sample Preparation Food Contact Surface Samples Stainless Steel Plastic 1 Use a non bactericidal 8x4X0 3 cm sterile cellulose sampling sponge that has been pre moistened with D E buffer Swab the surface to be tested with one side of the swab s in a horizontal direction approximately 10 cm and with the other side in a vertical direction approximately 10 cm back and forth one stroke back and one stroke forward to swab the entire area of 100 cm Place each surface sampled sponge in a sterile sample bag and keep at 4 2 C until it is ready for testing The sample should be tested within 8 h When ready to test pre warm the prepared Actero Listeria Enrichment Media at 29 or 32 C Add 90 mL of the pre warmed Actero Listeria Enrichment Media to each sponge sample in its sample bag Stomach the sample for 30 seconds at 265 rpm in a Stomacher 400 circulator Hand mixing is an acceptable alternative for stomaching To hand mix massage each sponge that is in the sealed bag for ap
11. proximately one minute For the enrichment phase close the bags and incubate the samples in an incubator for 24h at 29 0 5 C or for 28h at 32 0 5 C Adherence to temperature is important for accurate results FoodChek Listeria spp Package Insert FCLS 003 Page 3 of 8 7 Suite 450 1414 8 St S W P 403 269 9424 FoodChex Calgary Alberta T2R 1J6 F 403 263 6357 Food safety simplified Canada www foodcheksystems com Non Food Contact Surface Samples Ceramic Sealed Concrete Rubber 1 Use a non bactericidal 8Xx4X0 3 cm sterile cellulose sampling sponge that has been pre moistened with D E buffer Swab the surface to be tested with one side of the swab s in a horizontal direction approximately 10 cm and with the other side in a vertical direction approximately 10 cm back and forth one stroke back and one stroke forward to swab the entire area of 100 cm Place each surface sampled sponge in a sterile sample bag and keep at 4 2 C until it is ready for testing The sample should be tested within 8 h When ready to test pre warm the prepared Actero Listeria Enrichment Media at 32 C Add 90 mL of the pre warmed Actero Listeria Enrichment Media to each sponge sample in its sample bag Stomach the sample for 30 seconds at 265 rpm in a Stomacher 400 circulator Hand mixing is an acceptable alternative for stomaching To hand mix massage each sponge that is
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