Canine Adenovirus I Antigen Rapid Test(CAV-l Ag) Intended Use Canine Adenovirus I Antigen Rapid Test is a lateral flow immunoassay intended for the qualitative detection of specific antigen from Canine Adenovirus I (CAV-I) in eye,nasal fluid or saliva sample. The test is useful for determination of CAV-I infection. Reagent and Materials Provided • Test devices • Swabs • Buffer tubes • 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 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. 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. STEP 2 TEST PROCEDURE Take the test device out of the aluminum foil bag and place it on a clean and flat table. Add three drops (about 90 ql) of specimen (mixed sample) vertically 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. Unseal the extraction tube containing the buffer. Place the extraction tube in the workstation. Use the swab to collect secretions specimen from canine eye/ nose / mouth. Invalid: No colored line appears in C region, regardless of T line’s appearance. Rotate the swab more than 10 times. I Close the cap of the buffer tube. Limitations Although the Canine Adenovirus I Antigen Rapid Test is very accurate in detecting Canine Adenovirus I Antigen, 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 Diagnostic Sensitivity of CAV-I Ag : 185/190=97.37% (95%CI*(93.82%-99.04%)) Diagnostic Specificity of CAV-I Ag : 124/130=95.38% (95%CI*(90.08%-98.08%)) Total Agreement of CAV-I Ag : 309/320=96.56% (95%CI*(93.88%-98.14%)) batch code in vitro diagnotic medical device contains sufficient for <n> tests temperature limitation