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1. consequential damages This Limited Warranty states the entire obligation of EnviroLogix with respect to the Products If any part of this Limited Warranty is determined to be void or illegal the remainder shall remain in full force and effect License EnviroLogix has developed some tests in this kit using proprietary reagents as well as reagents licensed from Monsanto Company Roundup Ready is a registered trademark of Monsanto Technology LLC LibertyLink is a trademark of Bayer CropScience AG EnviroLogix the EnviroLogix logo QuickComb QuickStix QuickScan and Common Extraction are trademarks of EnviroLogix Inc EnviroLogix 20142. container to burst Dispose of extract when testing is complete Rev 09 12 14 QuickComb Kit for QuickScan Bulk Soybeans Page 4 of 4 For Technical Support Contact Us At EnviroLogix 500 Riverside Industrial Parkway Portland ME 04103 1486 USA Tel 207 797 0300 Toll Free 866 408 4597 Fax 207 797 7533 e mail info envirologix com website www envirologix com Rev 09 12 14 LIMITED WARRANTY EnviroLogix Inc EnviroLogix warrants the products sold hereunder the Products against defects in materials and workmanship when used in accordance with the applicable instructions for a period not to extend beyond a product s printed expiration date If the Products do not conform to this Limited Warranty and the customer notifies EnviroLogix in writing of such defects during the warranty period including an offer by the customer to return the Products to EnviroLogix for evaluation EnviroLogix will repair or replace at its option any product or part thereof that proves defective in materials or workmanship within the warranty period ENVIROLOGIX MAKES NO OTHER WARRANTIES EXPRESS OR IMPLIED INCLUDING BUT NOT LIMITED TO ANY IMPLIED WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR PURPOSE The warranty provided herein and the data specifications and descriptions of EnviroLogix products appearing in EnviroLogix published catalogues and product literatures are EnviroLogix sole represen
3. 5 PAT pat LibertyLink 1 soybean in 200 0 50 How the Test Works In order to detect the proteins expressed by genetically modified bulk grain the sample must first be extracted to solubilize the protein All QuickStix included in the QuickComb are specially formulated to detect their analytes in a Common Extraction Each QuickStix Strip has an absorbent pad at each end The protective tape with the arrow indicates the end of the strips to insert into the reaction cup The sample will travel up the membrane strips and be absorbed into the larger pad at the top of the strip The portion of the strip between the protective tape and the absorbent pad at the top of the strip 1s used to view the reactions as described under Interpreting the Results Results may then be scanned and interpreted quantitatively with the EnviroLogix QuickScan System Please avoid bending the comb Sample Preparation Step 1 Determine Number and Size of Sub samples 1 Collect a composite sample according to USDA GIPSA instructions found in the reference documents listed in the margin on Page 2 2 The following is another helpful reference for use in designing a sampling plan Remund K M Dixon D A Wright D L Holden L R Statistical considerations in seed purity testing for transgenic traits Seed Science Research June 2001 Vol 11 No 2 pp 101 119 3 To select the appropriate sample size determine the purity standard and the degree of co
4. ENVIRQLOGIX Highlights e Results in 5 minutes or less e Convenient comb format e One Common Extraction Roundup Ready LibertyLink e Quantitation with QuickScan Contents of Kit e 100 or 40 QuickCombs packaged 10 combs per canister e Sample cups and disposable transfer pipettes Items Not Provided e Blender for sample prep 1 Oster Sunbeam blender model 4094 with 4 oz polystyrene blender jar ice crusher blade gasket and blender base or 2 Waring blender model 31BL91 or equivalent with glass Mason jars and jar adapter Eberbach E8495 along with protective cover 3 BUNN coffee grinder industrial style grinder set on AutoDrip setting e Graduated cylinder e Tap water e Protective cover for blender jar while grinding e QuickScan System optional for quantitative results For sampling scenarios at different screening or confidence levels refer to the USDA GIPSA Excel spreadsheet described below or call EnviroLogix Technical Support for assistance Rev 09 12 14 QuickComb Kit for QuickScan Bulk Soybeans Catalog Number AQ 076 TC Intended Use This EnviroLogix QuickComb Kit for QuickScan Bulk Soybeans is designed to extract and detect the presence of certain proteins at the levels typically expressed in genetically modified soybeans The QuickComb contains the following QuickStix Protein Trade Name Sensitivity CP4 EPSPS Roundup Ready 1 soybean in 400 0 2
5. ckCombs in the container Precautions and Notes e This kit is designed to be read visually as a screen for presence or absence and is also designed to be quantitative when used with the QuickScan System e As with all tests it is recommended that results be confirmed by an alternate method when necessary e The assay has been optimized to be used with the protocol provided in the kit Deviation from this protocol may invalidate the results of the test e The results generated through the proper use of this kit reflect the condition of the working sample directly tested Extrapolation as to the condition of the originating lot from which the working sample was derived should be based on sound sampling procedures and statistical calculations which address random sampling effects non random seed lot sampling effects and assay system uncertainty A negative result obtained when properly testing the working sample does not necessarily mean the originating lot is entirely negative for the analyte or protein in question e A strong positive result may safely be interpreted in as little as 2 minutes after sample addition It 1s not safe however to interpret negative results prior to 5 minutes e Protect all components from hot or cold extremes of temperature when not in use Do not leave in direct sunlight or in a vehicle e CAUTION Tightly closed containers of soy extract if left sitting for several hours may ferment and cause the lid or
6. ection of each strip covered by the arrow tape Note Use extreme caution to prevent sample to sample cross contamination with grain fluids or disposables QuickComb Kit for QuickScan Bulk Soybeans Page 3 of 4 Control Line Test Line cut here Strip must develop a Control Line to be valid cut where indicated and read in QuickScan System Interpreting the Results Development of the Control Lines within 5 minutes indicates that the strips have functioned properly Any strip that does not develop a Control Line should be discarded and the sample re tested using another comb or corresponding strip Results are scanned and interpreted quantitatively with the QuickScan System Place QuickStix Strip into the carrier slide in and press Read Test on the screen QuickScan will return a result as GMO or lt LOD less than the Limit of Detection Please consult the QuickScan User Manual for details Kit Storage This QuickComb Kit should be stored at room temperature or refrigerated for longer shelf life Please note shelf life on the kit box for each storage temperature The kit may be used in field applications however prolonged exposure to high temperatures may adversely affect the test results Important do not open the canister until ready to use the combs Allow container to come to room temperature before opening to prevent condensation Immediately re seal unused Qui
7. igh speed all whole beans are finely ground Add the volume of tap water calculated above see formula above or at left EE a e Cap and shake jar vigorously until the entire sample is wet 20 30 seconds depending on the number of grains Sample will begin to settle immediately and liquid can be drawn off at that time Avoid pulling up particles with the transfer pipette 6 Transfer 12 mL of the liquid portion from above the settled sample into the sample cup The level should be above the bottom of the arrows but below the top of the lower colored portion 7 To prevent cross contamination thoroughly clean blender parts and jars to remove dust and residue prior to preparation of each sample and use a new sample cup for each If pipetting use a new tip or disposable pipette for each sample How to Run the QuickComb Test 1 Allow refrigerated canisters to come to room temperature before opening Remove the QuickCombs to be used Avoid bending the strips or handling the loose comb end Reseal the canister immediately 2 Place the comb into the three ounce cup containing 12 mL of the liquid soybean extract The sample will travel up the strips 3 Allow the comb to develop for 5 minutes before making final assay interpretations Positive sample results may become obvious much more quickly 4 Remove the QuickComb from the cup to read visually To retain the combs or for use in the QuickScan System cut off and discard the bottom s
8. nfidence required Confidence level means the statistical probability that the of GMO soybeans in the lot is below the selected purity standard This calculation should be done for each trait tested then choose the largest sub sample volume result Step 2 Determine Sub sample Weight Jar Size Grind Times and Water Volume Needed for Sample Preparation 1 Determine the average weight of the grain from the lot to be tested Count and weigh 100 kernels seeds then divide by 100 2 Calculate the sub sample weight g needed for testing number of seeds X average seed weight USDA References http archive gipsa usda gov reference library handbooks grain insp erbook1 bk1 pdf USDA Grain Inspection Handbook Book 1 Grain Sampling http archive gipsa usda gov biotech sample2 htm Guidance document entitled Sampling for the Detection of Biotech Grains http archive gipsa usda gov biotech samplel htm Practical Application of Sampling for the Detection of Biotech Grains http archive gipsa usda gov biotech samplingplan1 xls This website provides a simple to use Sample Planner 29K Excel Spreadsheet The planner allows you to enter different assumptions in terms of sample size number of samples acceptable quality level and to determine the probability of accepting lots with given concentration levels It also plots the probabilities in graph form for easy interpretation Specific data can be saved fo
9. r documentation and future analyses Choose grinding method Soybean Common Extraction Grams of beans x 5 mL water For example 100 x 0 15 I5 I5 gx 5 75 mL water Extract in tap water Transfer extract to cup about 3 pipettefuls Rev 09 12 14 QuickComb Kit for QuickScan Bulk Soybeans Page 2 of 4 3 Calculate water volume needed for sample preparation The Soybean Common Extraction uses a water volume to sample weight ratio of 5 to 1 Example Calculation using a 100 kernel sub sample with an average kernel weight of 0 15g 0 15g x 100 15 gx 5 mL 75 mL water for extraction 4 Choose an appropriate jar size and grind time based on the type of blender available for sub sample preparation see Table 2 Oster Sunbeam Blender with ice crusher blade is recommended over the Waring Blender for its bean grinding efficiency Note that bean grind time is longer and requires additional steps when using a Waring Blender Table 2 Soybeans Grind Time of Beans Sub sample on High approximate Blender Type weight g Jar size 0Z Speed 100 200 200 E OO 1638 20 seconds E OED 60 seconds For best results blend beans for 1 2 of total time remove the jar and shake to redistribute larger particles replace and resume grinding 60 seconds 16 38 ts KERS Step 3 Prepare the Sample Weigh sample into the appropriate vessel Put protective cover over glass jars Grind sample on h
10. tations concerning the Products and warranty No other statements or representations written or oral by EnviroLogix employees agents or representatives except written statements signed by a duly authorized officer of EnviroLogix Inc are authorized they should not be relied upon by the customer and are not a part of the contract of sale or of this warranty EnviroLogix does not warrant against damages or defects arising in shipping or handling or out of accident or improper or abnormal use of the Products against defects in products or components not manufactured by EnviroLogix or against damages resulting from such non EnviroLogix made products or components EnviroLogix passes on to customer the warranty it received if any from the maker thereof of such non EnviroLogix made products or components This warranty also does not apply to Products to which changes or modifications have been made or attempted by persons other than pursuant to written authorization by EnviroLogix THIS WARRANTY IS EXCLUSIVE The sole and exclusive obligation of EnviroLogix shall be to repair or replace the defective Products in the manner and for the period provided above EnviroLogix shall not have any other obligation with respect to the Products or any part thereof whether based on contract tort strict liability or otherwise Under no circumstances whether based on this Limited Warranty or otherwise shall EnviroLogix be liable for incidental special or
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