AFFIGEN AFG-VR-29 AffiVET Rapid Test Kit Instruction Manual

June 13, 2024
AffiGEN

AFFIGEN AFG-VR-29 AffiVET Rapid Test Kit

Material Required

  • (10) Rapid Canine CHW Antigen Test device
  • (10) Disposable Dropper
  • (10) Anticoagulant tube
  • (01) Instruction of Use
  • (01) Timer (Not Provided)

Storage

  1. Store the test kit at 2~30℃. DO NOT FREEZE.
  2. Do not store the test kit in the direct sunlight.
  3. The test kit is stable within the expiration date marked on the package label.

Principle

  • The AffiVET® CHW Antigen Rapid Test Kit is a chromatographic immunoassay designed for the semiquantitative detection of Canine Dirofilaria immitis antigen in canine serum, plasma, or whole blood.
  • This test kit features a test (“T”) line and a control (“C”) line on the device’s surface, both of which are initially invisible before sample application. The appearance of the control line serves as a reference, indicating that the test is functioning correctly and should appear consistently with each test.
  • When IgG antibodies specific to canine heartworm antigens are present in the sample, a purple test line will appear in the result window.
  • The Highly selective antibodies to Canine Dirofilaria immitis antigens are utilized as both capture and detector components in the assay, enabling the accurate detection of IgG antibodies to Canine Dirofilaria immitis antigen in in samples with high precision.

Precautions

  1. Use this test kit exclusively for canine samples; do not use it for other animals.
  2. The test device is sensitive to humidity and heat, so perform the test immediately after removing it from the foil pouch.
  3. Do not reuse any test components to ensure accurate results.
  4. Apply the sample using a disposable dropper in a vertical manner.
  5. Avoid touching the membrane in the result window of the test device.
  6. Do not use the test kit beyond its expiration date indicated on the package label.
  7. Do not use the test kit if the pouch is damaged or if the seal is broken.
  8. Refrain from mixing components from different lot numbers, as each kit undergoes quality control testing as a standard batch unit.
  9. Treat all samples as potentially infectious and wear protective gloves during handling.
  10. Thoroughly wash hands afterward. Dispose of all samples, reaction kits, and potentially contaminated materials safely in accordance with national and local regulations.
  11. Strictly follow the test procedures to minimize false or invalid test results due to improper administration of the product usage or doses.

Collection & Preparation

For this test, only Canine whole blood, serum, plasma, should be used.
Whole blood

  • Collect blood, using a disposable syringe.
  • Place the collected blood sample into the anticoagulant tube.
  • Secure the cap on the anticoagulant tube and invert it five times to mix the blood and EDTA.
  • Test the collected blood either immediately or within 4 hours at room temperature. After testing, store it between 2~8°C for up to 24 hours.
  • Samples with significant hemolysis may impact the test outcome.

Serum

  • Collect blood in a tube without anticoagulants (e.g., heparin, EDTA, sodium citrate), let it settle for 30 minutes to clot, then centrifuge to obtain serum.
  • Refrigerate the collected serum at 2-8°C for up to 2 weeks. For longer storage, freeze it at -20°C or below for up to 1 year

Plasma

  • Collect blood in a tube with anticoagulants, then centrifuge to obtain plasma.
  • Refrigerate the collected plasma at 2-8°C for up to 2 weeks. For longer storage, freeze it at -20°C or below for up to 1 year.

Test Procedure

  1. All reagents and samples must be at room temperature (15~30°C) for 15~30 minutes before use.
  2. Remove the test device from the foil pouch, and place it on a flat and dry surface.
  3. Using a disposable dropper, add 2 drops of sample into the sample hole vertically.
  4. Start the timer. The sample will flow across the result window. If it does not appear after 1 minute, add one more drop mixed sample to the sample hole.
  5. Interpret test results at 5-10 minutes. Do not interpret after 20 minutes.

Result Interpretation

Negative Result

  • Presence of C-Line
  • Absence of T-Line

Positive Result

  • Presence of C-Line
  • Presence of T-Line

Invalid Result

  • Absence of C-Line

  • Presence of T-Line

  • Absence of C-Line

  • Absence of T-Line

Limitations

  1. While the AffiVET® Canine heartworm antigen Test Kit is highly accurate in detecting Canine heartworm antigen, occasional false results may occur. In cases of uncertainty, additional clinical or laboratory tests may be necessary. A conclusive clinical diagnosis should rely on thorough evaluation by a veterinarian, considering all clinical and laboratory findings, rather than solely on the result of a single test.
  2. The reading window may display a light pink background coloration, which does not impact the accuracy of the results.
  3. AffiGEN Inc. and its distributors cannot be held liable for any consequences resulting from the misuse or misinterpretation of the test results.

Contact us

Phone 800-660-1620
Emailinfo@affigen.com
Websitewww.affigen.com

References

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