Feline Coronavirus Antibody Rapid Test(FCoV Ab) Intended Use Feline Coronavirus Antibody Rapid Test is a lateral flow immunoassay intended for the qualitative detection of specific antibody from Feline Coronavirus (FCoV) in feline ascites, serum, plasma or whole blood samples. The test is useful for determination of FCoV infection. Reagent and Materials Provided • Test devices • Capillary droppers • Buffer • 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 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.Whole blood, serum or plasma should be used with this test. 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 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 Check the product contents and make sure the test operation is under the room temperature (15—30C) before testing. Limitations Although the Feline Coronavirus Antibody Rapid Test is very accurate in detecting Feline Coronavirus 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 STEP 2 TEST PROCEDURE Take the test device out of the aluminum foil bag, and place it on a clean, flat table. Use a dropper to draw some whole blood, serum or plasma specimens, add one drop (about 10 ql) 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. Diagnostic Sensitivity of FCoV Ab: 162/170=95.29%(95%CI* (90.84%-97.74%)) Diagnostic Specificity of FCoV Ab: 153/160=95.63%(95%CI* (91.08%-98.03%)) Total Agreement of FCoV Ab: 315/330=95.45%(95%CI* (92.58%-97.28%)) Negative (-): Only clear C line appears. Invalid: No colored line appears in C region, regardless of T line’s appearance. in vitro diagnotic medical device contains sufficient for <n> tests temperature limitation