Rabies Antibody Rapid Test(RAB Ab) Intended Use Rabies Antibody Rapid Test is a lateral flow immunoassay intended for the qualitative detection of Rabies Antibody (RAB Ab) in serum or plasma sample. Reagent and Materials Provided ■ Test devices • Disposable droppers • Package insert Materials Required but not Provided Timer Storage and Stability The test device is sealed and should be stored away from light at a room temperature (4-30°C). Do not freeze. The test device should be used before the expiration date marked on the package label. Warnings, Precautions and Safety Information 1. The test device is used for canine and feline 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. 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. Specimen Collection, Handling, and Transport I.Serum or plasma should be used with this test. Serum: Collect the whole blood into the collection tube (NOT containing anticoagulants such as heparin, EDTA and sodium citrate), and then 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 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 inconsis tent test results. They must be clarified prior to assaying. 4.Hemolyzed or contaminated samples may lead to erroneous results. STEP 1 CHECK THE KIT CONTENTS BEFORE USE Test device Disposable dropper Buffer tube Package insert Check the product contents and make sure the test operation is under the room temperature (15—30C) before testing. STEP 2 TEST PROCEDURE Limitations Although the Rabies Antibody Rapid Test is very accurate in detecting Rabies 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. Performance Characteristics Method Take the test device out of the aluminum foil bag, and place it on a clean, flat table. Use a dropper to draw some serum or plasma specimens, add one drop (about 30 mL) into the specimen well (S) of the test device, and then immediately add two drops (about 60 ql) of buffer into the specimen well (S) of the test device. STEP 3 INTERPRETATION OF TEST RESULT Read the result at 5-10 minutes. The result is invalid after 15 minutes. 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 in vitro diagnotic medical device temperature limitation Hangzhou Antigenne Technology Co., Ltd Address:Block A, Building 3, No. 8, Xiyuan 9th Road, Xihu District, Hangzhou, Zhejiang, 310030 P.R. China