Warnings, Precautions and Safety Information Canine Total IgE Rapid Test (C.IgE) Check the product components and ensure that the operation is carried out at room temperature (15-30°C). Positive (+): The presence of both C line and T line, regardless of T line being strong or faint. 1. The test device is used for canine only. 2. The results may be influenced by humidity and temperature. TEST PROCEDURE 3. Make sure that the foil pouch containing the test is not damaged before open. Perform the test immediately Negative (-): Only clear C line appears. when the pouch package is opened. 4. Do not reuse the test components. 5. Do not use after the expiry date. Intended Use Canine Total IgE Rapid Test is a chromatographic immunoassay kit for rapid detection of IgE in canine serum or plasma. Invalid: No colored line appears in C region, regardless of T line’s appearance. numbers. 7. As all samples are potentially infectious. Operators should wear protective gloves while handling samples Use a sampling pipe to draw some serum or plasma specimens and wash hands thoroughly afterwards. 8. Decontaminate and dispose of all samples, used kits The Canine Total IgE Test Kit is a qualitative test card. and potentially contaminated materials safely in This test aimed to the detection of canine IgE in serum/ accordance with national and local regulations. (approximately 10 µL) through the capillary it moves along the nitrocellulose membrane with the gold-labeled reagent. If the sample contains canine plasma based on the principle of immunochromatography. When the sample to be tested is added to the sample well, 6. Do not mix product components in different lot Although The Canine Total IgE Test is very accurate in detecting Specimen Collection, Handling, and Transport Canine IgE, a low incidence of false results may be occurred. Other clinically or laboratory tests might be required if questionable results are obtained. As other diagnostic tests, a definitive allergen-specific IgE antibodies, they will bind with the 1.Serum or plasma should be used with this test. gold-labeled reagent and the antibodies on the test line, Serum: Collect the whole blood into the collection tube Peel off aluminum foil seal from the top of the extraction showing a purplish-red color. The control line will also (NOT containing anticoagulants such as heparin, EDTA tube containing the extraction buffer, insert sampling end test, but should be diagnosed by the veterinarian after all clinical show a red band as the gold-labeled reagent binds to the and sodium citrate), and then stand or centrifuge whole into pipe and cover tightly，mixed completely. and laboratory findings have been evaluated. antibodies on the control line. If the sample does not contain canine allergen-specific IgE antibodies or the Plasma: Collect the whole blood into the collection tube level is too low, no color reaction occurs or the color band (containing anticoagulants such as heparin, EDTA and sodium citrate) and then stand or centrifuge whole blood clinical diagnosis should not be based on the result of a single to get plasma. 2.Samples should be stored at 2~8°C. Please freeze the · Test devices · Sampling pipes · Buffer tubes · Package insert Materials Required but not Provided samples at ‐20°C or below for longer storage and avoid repeated freezing and thawing. 3. Samples containing precipitate may yield inconsistent Holding the sampling pipe upright, carefully take off the test results. They must be clarified prior to assaying. cap of sampling pipe, transfer 3 drops (approximately 90 4. Hemolyzed or contaminated samples may lead to µL) to the specimen well (S) of the test device. erroneous results. Timer CHECK THE KIT CONTENTS BEFORE USE INTERPRETATION OF TEST RESULT contains sufficient for tests in vitro diagnotic medical device temperature limitation Address：Block A, Building 3, No. 8, Xiyuan 9th Road, Xihu District, Hangzhou, Zhejiang, 310030 P.R. China from light at a room temperature (4-30℃). Do not freeze. The test device should be used before the expiration date marked on the package label. Hangzhou Antigenne Technology Co., Ltd The test device is sealed and should be stored away Reagent and Materials Provided Test device Sampling pipe Buffer tube Package insert Read the result at 5-10 minu