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8. 3 Precautions Regarding Disposal of Waste Materials 2 Food Discard the kits test samples and surplus sample solutions in strict compliance with your local waste disposal regulations and with full consideration of environmental sanitation Storage Method and Use By Date Storage method Refrigerate at 2 8 C and shade from the light Avoid freezing Use by date 12 months from the date of manufacture Stated on the external package and on each component References 1 Ministry of Health Labour and Welfare Labels for foods containing allergenic substances Shokukihatsu No 2 Shokukanhatsu No 46 dated March 21 2001 final revision Shokuankihatsu No 012201 Shokukanhatsu No 0122002 dated January 22 2009 2 Ministry of Health Labour and Welfare Enforcement of the ministerial ordinance partially amending the Ordinance for Enforcement of the Sanitation Act Shokuanhatsu No 0603001 dated June 3 2008 3 Ministry of Health Labour and Welfare Interim report outline by the Allergy Labeling Commission Food Labeling Study Team October 29 2001 4 Ministry of Health Labour and Welfare Methods of the test of foods containing allergenic substances final revision Shokuanhatsu No 0122001 dated January 22 2009 Manufactured by Nippon Meat Packers Inc R amp D Center COSMO BIO CO LTD Inspiration for Life Science TOYO 2CHOME KOTO KU TOKYO 135 0016 JAPAN http www cosmobio co jp e mail
9. 1 Components 2 Ingredients A Test strip RE RE sia 2 test x 10 packs 1 Reagent containing section B Dilution Buffert ter 30mLx1 bottle Gold colloid labeled anti milk protein antibody rabbits C Extraction buffer 1 10 concentration 100mLx1 bottle 2 Detecting section D Instruction manual 1 sheet Anti milk protein antibody rabbits E Plastic pouched bag rm 1 bag Anti rabbit immunoglobulin antibody goat Application 1 Detection of milk protein in foods or solutions Illustration of Test strip and the Principle of assay 1 Illustration of Test strip a Sample solution drop section Be careful not to touch this section with your finger b Reagent containtng section Cs Detecting section Be careful not to scratch this section and touch this section with your finger d Absorbent pad e Measurement items listing position f Test line appearance position Approx 30mm_from_the sample solution drop section g Control line appearance position Approx 38mm_from_the sample solution drop section 2 Principle of assay When a sample solution is dropped onto the sample solution drop section of the test strip the gold colloid labeled anti milk protein antibody 2 in the 1 reagent containing section dissolves and forms complexes with milk protein al Y 1 These complexes move to the detecting section by capillary attraction and are
10. 4 C The shelf life of the sample solutions varies depending on the foods Perform the test as soon as possible Preparation of the sample solution 2 Smear test etc 1 Required Equipment and Instruments Test tube etc swab micropipettes etc 2 Preparation of reagents and devices Note 1 Smearing solution and swab Prepare 0 9 sodium chloride solution physiological saline as the smearing solution and dispense a certain portion into a test tube etc Immerse a swab in the dispensed smearing solution Note 2 3 Note 1 A commercially available smearing kit for microbiological tests can be used However please beware of the composition of the solution contained Note 2 Since there is a risk of contamination of the manufacturing machine and devices with the smearing solution do not use the dilution buffer or the extraction buffer 1 10 concentration provided in the kit Note 3 The sensitivity of the smear test may vary depending on the amount of the dispensed smearing solution The minimum volume of the dispensed smearing solution should be 1 mL Determine the optimal volume by yourself 3 Smearing operation example of ordinary operation 1 Specify the smearing sites of the target machines and tools Note 1 2 Rub the designated smearing sites in 1 with a swab which has been moisturized in advance Note 2 3 Thoroughly wash the swab with the smearing solution to suspend the milk protein adhered to the swab No
11. solutions exhibited positive results and all negative sample solutions show negative results 3 False Positive False Negative Results 1 Cross reactivity with the specified ingredients other than milk egg wheat buckwheat peanut shrimp and crab and soybeans has not been observed 2 False positive results may be obtained due to non specific reactions in the presence of viscous food or very high of concentrations of protein In such cases dilute the sample to an appropriate concentration before conducting the test COSMO BIO CO LTD Inspiration for Life Science 3 4 5 6 Pressurized and heated food packaged in containers canned food and food in retort pouch packaging may exhibit false negative results Lactose may exhibit a false negative result because the content of milk protein is small When the sample solution contains a high concentration of milk protein an obscure line or no line may be observed in the smear test In such cases dilute the sample to an appropriate concentration before conducting the test See the List of Foods Exhibiting False Positive and False Negative Results on the website of Nippon Meat Packers Inc R amp D center for the foods exhibiting false positive or false negative results Precautions in Using the Kit 1 Precautions in Handling the Kit 0 2 3 4 5 6 7 Read the instruction manual carefully before use Use the kit in accordance with
12. the test method described in this manual Do not use a kit whose use by date has passed The expiry date is indicated on the label on the external package of the kit and on the aluminum pouch of the test strip The kit is a reagent designed to detect milk protein in foods or solutions It is not a reagent for diagnosing the presence or absence of food allergy to milk Correlation between the results obtained from the test with this kit and the occurrence of allergic symptoms has not been confirmed Globally judge the presence or absence of milk protein not only on the basis of the results obtained with this kit but also using other methods such as confirmation of raw materials and ingredients and production records Ask their manufacturers or distributors about how to use the equipments and instruments to be used for the test with this kit This instruction manual is intended as a guideline for those in charge of testing Verify your own operating procedures for the kit and the appropriateness of its use for each particular food Product specifications may be changed without notice 2 Precautions Regarding Risk Prevention 2 Beware so that the reagents of this kit or sample solutions do not adhere to skin mucosa or clothes If you accidentally get any reagent or sample solution in your eyes or mouth take emergency measures such as immediately washing away the solution with tap water and then seek medical attention if necessary
13. COSMO BIO CO LTD Inspiration for Life Science August 2009 1 edition Reagent for food testing FASTKIT SLIM MILK lt lt Instruction Manual gt gt Please read this manual before using this product Cat NPH NFS002 Introduction The Food Sanitation Law obliges that 7 specified allergenic ingredients egg milk wheat buckwheat peanut shrimp and crab which have a high risk of inducing food allergy should be listed on food labels The Food Sanitation Law also recommends that 18 ingredients including soybeans should be listed on the label in a way similar to the specified allergenic ingredients Providing accurate information by listing of ingredients on food labels and preventing contamination with the ingredients which are not listed on the labels are required to prevent food allergy Moreover as a measure to prevent contamination routine management at the manufacturing sites including verification of the process of washing the machines and devices used for production is important This product is a kit for detecting milk protein by immunochromatography Tests can be conducted rapidly and simply by means of the kit Product Features 1 The simple one step operation enables easy assessment and anybody can perform the test easily 2 Because there is no need for special test equipment and the test gives rapid results in 15 minutes it is best for routine management at the production sites Kit contents
14. export cosmobio co jp Phone 81 3 5632 9617 FAX 81 3 5632 9618 3C1 IN Nippon Ham Group FASTKIT 21 12 Ja gt IZEARA FASTKIT NICHT 2 x 10 50mLx 1 100mLx1 1 1 FASTKIT FASTKIT alae FASTKIT 20 32 ooo Ye tit 208A 92 00071 FASTKIT 8 2 10 2 8 C 12 6 7 11 0 RH sen FASTKIT
15. he sample solution into a test tube and attach the test strip to the test tube so that the sample solution drop section of the test strip is immersed in the sample solution see the figure on the right Notes 3 4 Absorbent pad Ou a 100 uL portion of the solution Dispense a 150 uL portion of the test Note 1 Do not remove the test strip from the aluminum pouch until it has returned to room temperature otherwise incorrect test results may be obtained as a result of moisture absorption Test strips which are not used should be placed in the plastic pouch bag again together with a desiccant and should be preserved in a refrigerator Note 2 Be careful not to scratch the sample solution drop section or detecting section and do not touch them with your fingers When handling the test strip make sure that you hold the absorbent pad Note 3 Make sure that you change the pipette or chip to drop or dispense the sample solution for every sample solution Note 4 Make sure that the 100 uL portion of sample solution does not overflow the test strip when dropping it If necessary drop the solution in two or more portions Judgment of the Test Results 1 The test results is judged as positive when a reddish purple line is i T Test line appearance position Control line appearance position observed at the test line appearance position and at the control line 30 mm from the sample 38 mm from the sample appearance position 15 minutes after t
16. he start of the test solution drop section solution drop section 2 Judge the test results as negative when no reddish purple line is 1 Positive observed at the test line appearance position but a line is observed at N the control line appearance position Note 1 Be sure to use the results obtained 15 minutes after the start of the test as the test results Deviation from the 15 minute results may 2 Negative occur as time goes by Note 2 Judge the test results as positive if a reddish purple line is observed regardless of the shading of the reddish purple line Note 3 Retest in cases where no reddish purple line is observed at the control appearance position It is likely that there is something abnormal in the development of the sample solution in such cases Note 4 This kit is a reagent designed to identify milk protein qualitatively It cannot determine the content of milk protein Use FASTKIT ELISA VerIT Milk if you need to determine the content of milk protein Performance 1 Sensitivity Test The results of tests conducted in accordance with instructions for the preparation of the sample solution and the operating procedures described in this instruction manual will be positive when the concentration of milk protein in the sample solution is 25 ng mL or more 2 Repeatability Tests When positive and negative sample solutions of milk protein were simultaneously tested three times each all positive sample
17. te 3 4 Use the suspended smearing solution as the sample solution Note 4 Note 1 It is recommended that the smearing sites should be the sites where stains are likely to remain or the sites which are difficult to wash Note 2 It is recommend that the entire surface of the smearing site should be rubbed Note 3 After you have washed the swab you should thoroughly squeeze out the smearing solution absorbed by the swab using the wall of the test tube etc Note 4 If the sample solution contains insoluble matters in a large amount accurate results may not be obtained Insoluble matters should be eliminated as much as possible by centrifugation or filtration Note 5 When physiological saline is used for dispensing the sample solution a very subtle line may be observed as time goes by Make assessment 15 minutes after the start of the test COSMO BIO CO LTD Inspiration for Life Science Operating Procedures for Testing 1 Leave the test strip in the aluminum pouch at room temperature and remove from the pouch immediately before use Notes 1 2 2 With an oil based marker pen write the name of the test sample or the number of the subject under test on the absorbent pad of the test strip removed from the pouch 3 Place the test strip carefully on the flat stand and drop a 100 uL portion of the sample solution onto the sample solution drop section see the figure on the left Otherwise dispense a 150 uL portion of t
18. trapped by the anti milk protein antibody 3 that is fixed in the test line appearance position This results in the appearance of a reddish purple 2 3 4 line of gold colloid This reddish purple line can be detected by visual inspection and used to judge the presence or absence of milk protein in the sample solution The excess gold labeled antibodies regardless of the presence or absence of milk protein in the sample solution travel further through the detecting section and are trapped by the anti goat immunoglobulin rabbit antibody 4 fixed at the control line appearance position where they form a second reddish purple line The presence of this line indicates that the sample solution has reached the detecting section COSMO BIO CO LTD Inspiration for Life Science Preparation of the sample solution 1 detection in food 1 Required Equipment and Instruments Grinder food cutter homogenizer Millser centrifuge 3 000xg or more 4 C is recommended sedimentation tubes etc filter paper funnel measuring cylinder beaker micropipette etc 2 Preparation of Reagent Dilution buffer Leave it at room temperature 20 C 25 C before use Extraction buffer 1 10 concentration Dilute the solution 1 10 with purified water before use Note 1 If any sediments are observed in the extraction buffer 1 10 concentration leave the solution at room temperature until the sediments dissolve and then dilute it with p
19. urified water Note 2 Since the dilution buffer and the extraction buffer 1 10 concentration of the FASTKIT Slim Series have the same composition they can be used for any type of tests 3 Extracting operation example of operation in ordinary foods 1 Grind the food to be tested sample of each package unit to be a more homogenous state using a grinder or food cutter Note 1 2 To 2 g of homogenized sample add 38 mL of the extraction buffer which is dispensed in advance and repeat the extracting operation 30 to 60 seconds x 3 times using a homogenizer etc Note 2 3 Centrifuge the above sample at 3 000xg or more 4 C for 20 minutes and filter the supernatant Note 3 4 Dilute the filtrate with the dilution buffer 1 10 and use it as the sample solution Note 4 Note 1 To prevent contamination via equipments thoroughly wash the equipments before use In particular grinders and homogenizers should be washed completely after processing of each sample Wash them with neutral detergent and soak them in alkaline detergent over night or perform ultrasonic cleaning with alkaline detergent Note 2 Determine the pH during extraction If necessary adjust the pH to the neutral pH 6 0 to 8 0 if necessary Note 3 Ifthe sample solution contains insoluble matters such as lipids in a large amount accurate results may not be obtained Insoluble matters should be eliminated as much as possible Note 4 Store the sample solution at
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