'SaberVetFeline Panleukopenia Virus/Infectious Peritonitis Virus/Giardia Antigen Combo Rapid Test(FPV/FIPV/F.GIA Ag)Intended Use Feline Panleukopenia Virus/ Infectious Peritonitis Virus/ Giardia Antigen Combo Rapid Test is a lateral flow immunoassay intended for the simultaneous qualitative detection of specific antigen from Feline Panleukopenia Virus (FPV) , Feline Infectious Peritonitis Virus (FIPV) and Feline Giardia (F.GIA) in fresh feces or rectal swab sample. The test is useful for simulta neous determination of FPV, FIPV and F.GIA infection. 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. Check the product contents and make sure the test operation is under the room temperature (15—30°C) before testing. Take the test device out of the aluminum foil bag and place it on a clean and flat table. Add three drops (about 90 pL) of specimen (mixed sample) vertically into the each 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. Performance Characteristics Method • Test devices • 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 (4-30C). 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. Positive (+): The presence of both C line and T line, regardless of T line being strong or faint. STEP 2 TEST PROCEDURE 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 some fresh feline feces or fecal sample from its rectum. And then put the swab into the buffer. Rotate the swab more than 10 times. Close the cap of the buffer tube. Invalid: No colored line appears in C region, regardless of T line’s appearance. Limitations Although the Feline Panleukopenia Virus/ Infectious Peritonitis Virus/ Giardia Antigen Combo Rapid Test is very accurate in detecting Feline Panleukopenia Virus Antigen, Feline Infectious Peritonitis Virus Antigen and Feline Giardia 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. Diagnostic Sensitivity of FIPV Ag: 145/150=96.67%(95%CI* (92.23%-98.78%)) Diagnostic Specificity of FIPV Ag: 146/150=97.33%(95%CI* (93.11%-99.19%)) Total Agreement of FIPV Ag: 291/300=97.00%(95%CI* (94.31%-98.50%))

Diagnostic Sensitivity of GIA Ag: 147/150=98.00%（95%CI* （94.02%-99.58%）） Diagnostic Specificity of GIA Ag: 148/150=98.67%（95%CI* （94.96%-99.94%）） Total Agreement of GIA Ag: 295/300=98.33%（95%CI* （96.04%-99.40%）） batch code contains sufficient for 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,