SaberVetCanine Heartworm Antigen/Ehrlichia/ Lyme/Anaplasma Antibody Combo Rapid Test(CHW Ag/EHR/LYM/ANA Ab)Intended Use Canine Heartworm Antigen/Ehrlichia/Lyme/Anaplasma Antibody Combo Rapid Test is a lateral flow immunoassay intended for the simultaneous qualitative detection of specific antigen from Canine Heartworm (CHW) and specific antibody from Ehrlichia (EHR)/Lyme (LYM)/Ana-plasma (ANA) in canine whole blood, serum or plasma samples. The test is useful for simultaneous determination of CHW/EHR/LYM/ANA infection . • Test devices • Quantitative droppers • Buffer tubes • Package insert 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. 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. STEP 2 TEST PROCEDURE Unseal the extraction tube containing the buffer. Squeeze the upper air bag to absorb the sample (whole blood/ serum/plasma) . Please make sure some sample getting into the lower air bag and there is no bubbles in the lower tube. Then press the upper air bag to transfer the sample (about 75 pi) left in the lower tube into the buffer. Take the test device from the aluminum foil bag, and place it on a clean and flat table. Add three drops (about 90 mI) of the 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. 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. Although the Canine Heartworm Antigen/Ehrli-chia/Lyme/Anaplasma Antibody Combo Rapid Test is very accurate in simultaneously detecting Canine Heartworm Antigen / Ehrlichia / Lyme / Anaplasma 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

ELISA Method （94.38%-99.61%）） Diagnostic Specificity of ANA Ab: 153/160=95.63%（95%CI* （91.08%-98.03%）） Total Agreement of ANA Ab: 310/320=96.88%（95%CI* （9.27%-98.37%）） batch code contains sufficient for tests in vitro diagnotic medical device temperature limitation （95.48%-99.69%）） Diagnostic Specificity of EHR Ab: 146/150=97.33%（95%CI* （93.11%-99.19%）） Total Agreement of EHR Ab: 343/350=98.00%（95%CI* （95.85%-99.39%）） Hangzhou Antigenne Technology Co., Ltd Address：Block A, Building 3, No. 8, Xiyuan 9th Road, Xihu District, Hangzhou, Zhejiang, 310030 P.R. China ELISA Method Diagnostic Sensitivity...