STEP 2 TEST PROCEDURE 'SaberVetCanine Infectious Hepatitis Antibody Rapid Test(ICH Ab) 7. As all samples are potentially infectious. Operators should wear protective gloves while handling samples and wash hands thoroughly afterwards. 8. Decontaminate and dispose of all samples, used kits and potentially contaminated materials safely in accordance with national and local regulations. Although the Canine Infectious Hepatitis Antibody Rapid Test is very accurate in detecting Canine Infectious Hepatitis Antibody, 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 clinical diagnosis should not be based on the result of a single test, but should be diagnosed by the veterinarian after all clinical and laboratory findings have been evaluated. Intended Use Canine Infectious Hepatitis Antibody Rapid Test is a lateral flow immunoassay intended for the qualitative detection of specific antibody from Canine Infectious Hepatitis (ICH) in canine serum, plasma or whole blood samples. The test is useful for determination of ICH infection. • Test devices • Capillary droppers • Buffer • Package insert Whole blood: Collect the whole blood. If whole blood samples are not immediately tested, they should be refrigerated at 2~8°C and used within 24 hours. Serum: Collect the whole blood into the collection tube (NOT containing anticoagulants such as heparin, EDTA and sodium citrate), and then stand or centrifuge whole blood to get serum. Plasma: Collect the whole blood into the collection tube (containing anticoagulants such as heparin, EDTA and sodium citrate) and then stand or centrifuge whole blood to get plasma. 2.Samples should be stored at 2~8°C. Please freeze the samples at -20°C or below for longer storage and avoid repeated freezing and thawing. 3.Samples containing precipitate may yield inconsistent test results. They must be clarified prior to assaying. 4.Hemolyzed or contaminated samples may lead to erroneous results. Take the test device out of the aluminum foil bag, and place it on a clean, flat table. Use a capillary dropper to draw some whole blood/serum/plasma specimens and add one drop (about 10 pL) to the specimen well (S) of the test device. Then, add two drops (about 60 pL) of buffer into the specimen well (S) of the test device. STEP 3 INTERPRETATION OF TEST RESULT Read the result at 5-1 0 minutes. The result is invalid after 1 5 minutes. The test device is sealed and should be stored away from light at a room temperature (4-30oC). Do not freeze. The test device should be used before the expiration date marked on the package label. 1. The test device is used for canine only. 2. The results may be influenced by humidity and temperature. 3. Make sure that the foil pouch containing the test is not damaged before open. Perform the test immediately when the pouch package is opened. 4. Do not reuse the test components. 5. Do not use after the expiry date. 6. Do not mix product components in different lot numbers. STEP 1 CHECK THE KIT CONTENTS BEFORE USE Check the product contents and make sure the test operation is under the room temperature (15—30C) before testing. Positive (+): The presence of both C line and T line, regardless of T line being strong or faint. Negative (-): Only clear C line appears. Invalid: No colored line appears in C region, regardless of T line’s appearance. contains sufficient for <n> tests temperature limitation Hangzhou Antigenne Technology Co., Ltd Address:Block A, Building 3, No. 8, Xiyuan 9th Road, Xihu District, Hangzhou, Zhejiang, 31 0030 P.R. China