【INTENDED USE】
The Canine Heartworm (CHW) Rapid Test Kit is a chromatographic immunoassay for the qualitative detection of canine Heartworm (CHW) Antigen in canine whole blood, serum or plasma.
【PRINCIPLE】
The invisible anti-CHW antibody (T line) and secondary antibody (C line) are immobilized on a nitrocellulose membrane in result window.Another anti-CHW antibody is conjugated with colloidal gold particle and immobilized on glass fiber as conjugate pad.When specimen is applied into the sample well on device, CHW antigen will bind to the gold conjugate and migrate on the surface of test strip by passive diffusion,and a visible T line will appear in result window after 10 minutes.The C line has to appear every time when the test has performed which indicates the test is performing properly.
【CONTENTS】
• Rapid Test
• Buffer
• Disposable pipettes
• Instruction for use
【STORAGE AND STABILITY】
• The kit should be stored at 2-30°C until the expiry date printed on the sealed pouch.
• The test must remain in the sealed pouch until use.
• Keep away from direct sunlight, moisture and heat.
• Do not freeze.
• Care should be taken to protect the components of the kit from contamination. Do not use if there is evidence of microbial contamination or precipitation. Biological contamination of dispensing equipment, containers or reagents can lead to false results.
【PRECAUTIONS】
• The test kit is for canine use only. Do not use for other animals.
• The device is sensitive to humidity and heat. Perform the test immediately after removing it from the foil pouch.
• Read the instructions carefully before operation and follow the instructions.
• Do not reuse the test components
• Do not use the test kit if the pouch is damaged or the seal is broken.
• Do not use the test kit beyond the stated expiration date marked on the label.
• Do not mix components from different lot numbers because
the components in this kit have been quality control tested as standard batch unit.
• All specimens should be handled as being potentially infectious.
• Decontaminate and dispose of all specimens, used kits and potentially contaminated materials safely in accordance with national and local regulations.
【SAMPLE COLLECTION AND PREPAIRATION】
• The testshould be performed using canine serum or plasma.
Serum: Collect the whole blood into the collection tube (NOT containing anticoagulants such as heparin, EDTA and sodium citrate), leave to settle for 30 minutes for blood coagulation and then centrifuge to get serum supernatant.
Plasma: Collect the whole blood into the anticoagulant tube (containing anticoagulants such as heparin, EDTA and sodium citrate) and then centrifuge to get plasma. Whole blood: Collect the whole blood into the anticoagulant tube. If anticoagulated whole blood is not immediately tested, they should be refrigerated at 2~8℃ and used within 24 hours.
2. If serum and plasma are not tested immediately, they should be stored at 2~8°C for 24 hours. For longer storage, freeze at -20°C or below.
3. If specimen contains precipitate, it may affect the test result. Such specimen must be clarified prior to assaying.
4. The use of hemolytic, or bacterially contaminated specimens should be avoided. Erroneous result may occur.
【OPERATION】
Bring tests, specimens, buffer and/or controls to room temperature (15- 30°C) before use.
1. Remove the test from its sealed pouch, and place it on a clean, level surface. Label the device with animal patient or control identification. For best results, the assay should be performed within one hour.
2. Using a dropper, add 1 drop of specimen into sample well on the test cassette.
3.Add 2 drops of assay buffer into sample well (S) vertically.
4. Wait for the colored band(s) to appear. The result should be read at 15 minutes. Do not interpret the result after 20 minutes.
【INTERPRETATION OF RESULTS】
POSITIVE: The presence of two lines as control line (C) andtest line(T)within the result window indicates a positive result.
NEGATIVE: The presence of only control line (C) withintheresultwindow indicates a negative result.
INVALID: If the control line (C) is not visible within the result windowafter performing the test, the result is consideredinvalid.Some causes of invalid results are because of not followingthe directions correctly or the test may havedeterioratedbeyond the expiration date. It is recommendedthatthespecimen be re-tested using a new test.
【TEST LIMITATIONS】
• This kit can provide fast and easy way to get aresult, butdonot completely exclude the possibility of a lowincidenceoffalse results which occur by various factors,veterinariansshould also consider other clinical symptoms andlaboratorydiagnostic methods to make the definite diagnosis.
• The kit will only indicate the presence of canineHeartworm(CHW) antigen in the specimen or not.
• A negative result may be obtained if the concentrationofthecanine Heartworm (CHW) antigen present inthespecimenisnot adequate or is below the detectable level of thetest.
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