Product and Intended Use The SNAP* Melamine Test Kit is an enzyme-linked immunoassay for the detection of melamine residues at or below 2.5 ppm in raw, commingled cow milk that will be used for processed milk. This test kit is intended for screening purposes only. Test Kit Components Cap SNAP Device Sample Tube Pipette SNAP Melamine Test Kit * Reagent Pellet Components Required, but Not Provided (Available through IDEXX ) • Heater block capable of maintaining an operating temperature of 45°C ±5°C (113°F ±9°F). Optional Items (Available through IDEXX) • SNAPshot* Reader • SNAPshot* DSR Reader Storage All materials must be refrigerated at 2°–8°C (36°–46°F). Test kits can be kept at room temperature, 18°–29°C (64°–84°F), during the day of use. Unused test kits must be returned to refrigeration. Note: Discard unused, unrefrigerated test kits at the end of the day. Not for use in NCIMS milk-regulatory programs. 06-18398-00 Sample Information • This test kit is only for use with raw, commingled cow milk that will be used for processed milk. This test kit is not intended for use with finished milk products or with raw commingled milk that will be processed to make milk powder or infant milk powder. • Samples must be refrigerated and tested within three days of collection. • Thoroughly mix the sample before testing. • DO NOT use abnormal-looking milk. Limitations and Warnings • This test kit is not intended for use with finished milk products or with raw commingled milk that will be processed to make milk powder or infant milk powder. • This test kit is not intended for use in U.S.-based National Conference on Interstate Milk Shipments (NCIMS) milk-regulatory programs. • The instructions in this insert must be carefully followed. Failure to follow these directions increases the probability of obtaining an incorrect result. • Do not mix sample tubes and devices from different foil packages. • Do not use test kit components past their expiration dates. • If the control spot fails to develop color, the assay is invalid and must be repeated. • The test result may be interfered by factors like unknown factors in raw milk, human operation factors and intrinsic limitation of diagnostic products in general. • Erroneous results can occur from improper test kit storage, inadequate sample mixing or sample handling errors associated with instrument or assay procedures. Before You Begin • Test kits can be kept at room temperature, 18°–29°C (64°–84°F), during the day of use. • Preheat the heater block to 45°C ±5°C (113°F ±9°F) for 5 minutes prior to beginning the test. Test Preparation • Remove the SNAP device, pipette and sample tube from the bag. NOTE: An unused SNAP device has two light-blue colored spots in the results window. This is normal. • Verify that your heater block has been preheated and the thermometer is stable at 45°C ±5°C (113°F ±9°F) for at least 5 minutes. • Check that the reagent pellet is at the bottom of the sample tube. If it is not, tap the tube to return the pellet to the bottom. © 2009 IDEXX Laboratories, Inc. All rights reserved. *SNAP and SNAPshot are trademarks or registered trademarks of IDEXX Laboratories, Inc. or its affiliates in the United States and/or other countries. Covered by U.S. Patent Nos.: 5,726,010; 5,726,013; 5,750,333 and/or 6,007,999. Other U.S. and/or foreign patents issued or pending. One IDEXX Drive Westbrook, Maine 04092 USA Tel: 1-207-556-4496 or 1-800-321-0207 Fax: 1-207-556-4630 Test Procedure 1. Pipetting the Sample a.Place the SNAP device in the heater block in a horizontal position. 1 b.Shake the milk sample thoroughly. c.Remove and discard the cap on the sample tube provided with the test kit. d.Using the IDEXX pipette, draw the milk sample (450 µL ±50 µL) to the indicator line. NOTE: To avoid air bubbles when pipetting, insert one-third of the pipette into the milk and slowly draw the sample into the pipette. e.Carefully add all of the milk sample from the pipette to the tube, and then shake the sample tube to dissolve the reagent pellet. Place the tube into the heater block IMMEDIATELY. 2 2. Incubating the Sample Incubate the sample tube in the preheated heater block at 45°C ±5°C (113°F ±9°F) for 2 minutes. 3. Adding the Sample to the SNAP Device a.Pour the contents of the sample tube into the sample well of the SNAP device and discard the tube. The sample will flow across the result window toward the blue activation circle. b.When the blue activation circle begins to disappear, push the activator button FIRMLY until it snaps flush with the body of the SNAP device. You will hear a distinct snapping sound when this is done correctly. c.Wait 8 minutes. 3 Sample Well Result Window Activation Circle Activator NOTE: The SNAP device must remain on the heater block in a horizontal position for the duration of the test. 4. Reading Results The results must be read within 30 seconds. Interpreting Test Results • SNAPshot Reader or the SNAPshot DSR Reader: Insert the SNAP device immediately after color development, and follow the instructions in the instrument manual for reading the device. • Visual Read: When interpreting results, position the SNAP device with the sample well to the left. The SNAP device must be read within 30 seconds after the completion of the 8-minute development step to get a valid result. NOTE: If color development does not occur in the control spot, retest the sample. Control Spot Sample Spot Negative Result The sample spot is darker than or equal to the control spot. Positive Result The sample spot is lighter than the control spot. NOTE: Positive samples should be tested with the SNAP Melamine Test Kit again. Samples that are repeatedly positive should be confirmed with high-performance liquid chromatography (HPLC) validated method. Sole reliance on use of this test kit may result in the rejection of milk that could be considered safe for human consumption. Samples that may require regulatory action should be confirmed with a validated method such as HPLC. Performance Information Sensitivity The SNAP Melamine Test Kit has been validated to detect melamine at or below 2.5 ppm in raw, commingled cow milk.
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