ATP Reagent Control Kit
Contents
1. Safety representative for a Returned Goods Authorization CEN English ii LIMITATION OF 3M LIABILITY 3M WILL NOT BE LIABLE FOR ANY LOSS OR DAMAGES WHETHER DIRECT INDIRECT SPECIAL INCIDENTAL OR CONSEQUENTIAL DAMAGES INCLUDING BUT NOT LIMITED TO LOST PROFITS In no event shall 3M s liability under any legal theory exceed the purchase price of the product alleged to be defective STORAGE Store 3M MLS ATP Reagent Control Kit at 2 8 C DO NOT FREEZE Store any unused reconstituted ATP at 2 8 C for no longer than 24 hours Expiration date and lot number are noted on each vial of ATP positive control 3M MLS ATP Reagent Control Kit reagents should not be used past their expiration date INSTRUCTIONS FOR USE Follow all product instructions carefully Failure to do so may lead to inaccurate results Wear appropriate protective apparel and follow standard good laboratory safety practices GLP REAGENT PREPARATION 1 Allow all solutions and reagents to reach ambient temperature prior to use Cold reagents may produce low relative light unit RLU readings and samples may be incorrectly interpreted as sterile false negative result Do not heat reagents to warm them as this may inactivate the reagents 2 Carefully open a vial of lyophilized ATP be careful not to touch the rubber stopper Pipette 0 5 mL of ATP Free Water into the vial Replace the stopper and invert the vial 5 10 times Allow at least 5 minutes for the ATP to rehydr2. the reagents have been properly stored The shelf life of rehydrated reagents are as follows ATPase 2 days at 2 8 C LL1 5 days at 2 8 C ATP control 24 hours at 2 8 C Table 1 Reagent control check troubleshooting overview CONTROL WELL WELLS CONTENTS Ext ATPase LL1 no ATP C1 Ext ATPase ae er Ext LL1 ATP 2527 e J7 2450 8518 seo Problem Problem Problem Problem Problem Problem ATP Wells A1 D1 LLI not Decreased are marginal properly not properly Contamination ATP control failures may dispensed dispensed or biofilm in and or LL1 indicate a p reagent lines problem with No A contamination Control in or biofilm in Wwells El F1 reagent lines temperature C probe not dispensing recovering Replace amber bottles and solutions rinse reagent lines with fresh ATP Free Water and Cleaning Solution Weekly Cleaning Procedure Repeat reagent control check CEN English a REFERENCE 1 U S Food and Drug Administration Code of Federal Regulations Title 21 Part 58 Good Laboratory Practice for Nonclinical Laboratory Studies EXPLANATION OF SYMBOLS A Caution or Warning consult product instructions BH Consult product instructions z The lot in a box and the hourglass symbols are symbols that represent lot number and expiration date The hourglass is followed by a year and month which represents the expiration date year and month YYYY MM
3. 1 reagent is proportional to the amount of ATP that is present in the test well When 3M MLS ATPase is present in a test well it degrades the ATP and low level light readings are obtained When no ATPase is present in a test well the 3M MLS ATP and the 3M MLS LL1 react to produce light and high light readings are obtained SAFETY The user should read understand and follow all safety information in the Product Instructions for the 3M MLS ATP Reagent Control Kit Retain the safety instructions for future reference ACAUTION Indicates a hazardous situation which if not avoided could result in minor or moderate injury and or property damage A CAUTION 3M MLS Reagent Control Kit powders before rehydration e May cause eye skin and respiratory tract irritation e Avoid eye and skin contact Avoid breathing dust Use only with adequate ventilation e Wash thoroughly after handling e For laboratory use only follow established laboratory procedures PRECAUTIONS CAUTION May cause eye skin and respiratory tract irritation Avoid eye and skin contact Avoid breathing dust Consult Safety Data Sheet for additional information USER RESPONSIBILITY Users are responsible for familiarizing themselves with product instructions and information Visit our website at www 3M com foodsafety or contact your local 3M representative or distributor for more information When selecting a test method it is important to recognize that external fact
4. 3M Product Instructions ATP10MLS EM Microbial Luminescence System MLS ATP Reagent Control Kit CEN English a 3M Issue Date 2015 09 Product Instructions Microbial Luminescence System MLS ATP Reagent Control Kit PRODUCT DESCRIPTION AND INTENDED USE The 3M Microbial Luminescence System MLS Reagent Control Kit is intended for use with the following instruments The 3M Microbial Luminescence System MLS the 3M Microbial Luminescence System MLS USB and the 3M Microbial Luminescence System MLS II A reagent check should be performed at least once each day just prior to using the first 3M Microbial Luminescence System MLS Ultra High Temperature UHT Dairy Screen Kit Use of this Kit will verify the function of the instrument as well as the 3M MLS UHT Dairy Screen Kit Reagents The 3M Microbial Luminescence System MLS ATP Reagent Control Kit utilizes a standard concentration of adenosine triphosphate ATP to ensure that the reagents in the 3M MLS UHT Dairy Screen Kits are performing satisfactorily A vial of the 3M Microbial Luminescence System MLS ATP Reagent Control Kit is reconstituted with ATP Free Water and this standardized solution of ATP is used to test the activity of both the 3M Microbial Luminescence System MLS ATPase and 3M Microbial Luminescence System MLS Luciferin Luciferase LL1 reagents The intensity of light produced in the bioluminescent reaction of ATP with the LL
5. The entire line after the hourglass represents the lot number YYYY MM AZ Store between given temperatures 3M Food Safety 3M United States 3M Center Bldg 275 5W 05 St Paul MN 55144 1000 USA 1 800 328 6553 3M Canada Post Office Box 5757 London Ontario NGA 4T1 Canada 1 800 563 2921 3M Europe and MEA 3M Deutschland GmbH Carl Shurz Strasse 1 D41453 Neuss Germany 49 2131 14 3000 3M Latin America 3M Center Bldg 275 5W 05 St Paul MN 55144 1000 USA 1 954 340 8263 3M Health Care 2510 Conway Ave St Paul MN 55144 USA www 3M com foodsafety 3M Asia Pacific No1 Yishun Avenue 7 Singapore 768923 65 64508869 3M Japan 3M Health Care Limited 6 7 29 Kita Shinagawa Shinagawa ku Tokyo 141 8684 Japan 81 570 011 321 3M Australia Bldg A 1 Rivett Road North Ryde NSW 2113 Australia 611300 363 878 2015 3M All rights reserved 3M is a trademark of 3M Used under license in Canada 34 8717 6872 6
6. ate The rehydrated ATP is ready to use and contains sufficient volume for 2 reagent control assays Once rehydrated the ATP control solution is active for 24 hours when stored at 2 8 C 3 Prepare fresh ATPase and LL1 OR verify that previously rehydrated reagents were recently prepared When stored at 2 8 C rehydrated ATPase is active for 2 days and LL1 is active for 5 days INSTRUMENT PREPARATION See 3M Microbial Luminescence System MLS User Manual for detailed instructions 1 Rinse the instrument lines A B and C with Injector cleaning fluid using the Wash Assay 2 Rinse the instrument lines A B and C with ATP Free water using the Wash Assay 3 Load the assay reagents ATPase on injector A extractant on injector B and LL1 on injector C onto the 3M MLS Instrument 4 Place a3M Microbial Luminescence System MLS Microwell Plate onto the plate carrier ensuring well AT is positioned at the left corner of the plate carrier closest to the user 5 Prime injectors A B and C using the Prime Assay os FOR REAGENT CONTROL CHECK Using a strip of six 3M Microbial Luminescence System MLS Microwell Strip 3008 pipette 50 uL of rehydrated ATP into each of the last four microwells C1 F1 Do not deposit 3M MLS ATP onto the sides of the wells 2 Place the 3M MLS Microwell Strip into a 3M Microbial Luminescence System MLS Microwell Strip Holder 3009 and place the holder onto the instrument
7. ors such as sampling methods testing protocols sample preparation handling and laboratory technique may influence results It is the user s responsibility in selecting any test method or product to evaluate a sufficient number of samples with the appropriate matrices and microbial challenges to satisfy the user that the chosen test method meets the user s criteria This product has not been tested with all possible UHT products testing protocols or with all possible strains of microorganisms It is also the user s responsibility to determine that any test methods and results meet its customers and suppliers requirements As with any test method results obtained from use of any 3M Food Safety product do not constitute a guarantee of the quality of the matrices or processes tested LIMITATION OF WARRANTIES LIMITED REMEDY EXCEPT AS EXPRESSLY STATED IN A LIMITED WARRANTY SECTION OF INDIVIDUAL PRODUCT PACKAGING 3M DISCLAIMS ALL EXPRESS AND IMPLIED WARRANTIES INCLUDING BUT NOT LIMITED TO ANY WARRANTIES OF MERCHANTABILITY OR FITNESS FOR A PARTICULAR USE If any 3M Food Safety Product is defective 3M or its authorized distributor will at its option replace or refund the purchase price of the product These are your exclusive remedies You must promptly notify 3M within sixty days of discovery of any suspected defects in a product and return it to 3M Please call Customer Service 1 800 328 1671 in the U S or your official 3M Food
8. plate carrier so Well Al is in the left upper corner of the plate carrier closest to the instrument Select the Reagent Control Assay from the list assays and click start to run the reagent control check Complete file and user information then click OK o A W Following favorable reagent check results the instrument and reagents are ready for use 6 Perform UHT Assay s according to the 3M MLS UHT Dairy Screen Kit Instructions for Use INTERPRETATION OF RESULTS The default specifications for a reagent check are as follows Wells A1 B1 Readings of lt 35 RLU in both wells indicate that there is no contamination in the instrument or reagents Wells C1 D1 Readings of lt 100 RLU in both wells indicate that the ATPase enzyme is active Wells E1 F1 Readings of gt 1500 RLU in both wells indicate that the LL1 enzyme and ATP control are active NOTE Pass Fail criteria for reagent checks and UHT testing may vary depending on customer or product requirements CEN English ii TROUBLESHOOTING TIPS 1 If the reagent check produces an unsatisfactory reading repeat the procedure with a fresh bottle of 3M MLS ATP Reagent and or 3M MLS ATPase and 3M MLS LL1 If the reagent check fails again it may indicate a problem with one or more reagents or with the 3M MLS Instrument itself Refer to Table 1 for specific result scenarios during reagent control check 2 Check the expiration date on all reagent bottles and ensure that
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