AFFIGEN AFG-VR-55 Feline Coronavirus FCoV Antigen Rapid Test Kit Instruction Manual

June 14, 2024
AffiGEN

AFFIGEN AFG-VR-55 Feline Coronavirus FCoV Antigen Rapid Test Kit

Product Specifications

  • Product Name: Feline Coronavirus FCoV Antigen
  • Model Number: AFG-VR-55
  • Tests: 10 Tests
  • Storage: 2~30°C, Do not freeze
  • Expiry Date: Check package label

Product Usage Instructions

Principle
This test kit features a test (T) line and a control (C) line. The control line confirms proper test performance, while the appearance of a purple test line indicates the presence of FCoV antigens in the sample.

Precautions

  1. Use the test kit only for feline specimens.
  2. Test promptly after removing from foil pouch.
  3. Do not reuse disposable dropper.
  4. Apply sample using dropper vertically.
  5. Avoid touching the membrane in the result window.
  6. Adhere to expiration date; do not use expired kit.
  7. Discard if pouch is damaged or seal is broken.
  8. Do not mix components from different lot numbers.

Sample Collection & Preparation:

  1. Use feline feces exclusively as the sample.
  2. Test samples immediately after collection.
  3. Use the appropriate amount of fecal swab to avoid false results.

Test Procedure

  1. Collect fecal samples using a swab.
  2. Mix sample in assay diluent tube until dissolved.
  3. Invert sample tube 3-5 times.
  4. Allow for settling of large particles.
  5. Apply mixed sample into the test device sample hole.
  6. Initiate timer and wait for migration across the result window.
  7. Interpret results precisely at 10 minutes.

Result Interpretation:

  • Negative Result: Control (C) line only
  • Positive Result: Test (T) line and Control (C) line
  • Invalid Result: Retest if control (C) line is absent

Frequently Asked Questions (FAQ):

  • Q: Can this test be used on animals other than felines?
    A: No, this test kit should only be used for feline specimens.

  • Q: What should I do if the control line does not appear in the result window?
    A: An absent control line renders the result invalid. It is recommended to retest the sample in such cases.

Feline Coronavirus FCoV Antigen

AffiVET® Rapid Test Kit
AFG-VR-55 10 Tests

Material Required

  • (10) Rapid FCoV Ag Test Device (10) Assay Diluent Tube
  • (10) Disposable Swab
  • (10) Disposable Dropper
  • (01) Instruction of Use
  • (01) Timer (Not Provided)

Storage

& Expiry Date

  1. Store the test kit at 2~30℃. DO NOT FREEZE.
  2. Avoid direct Sunlight.
  3. The test kit remains stable until the expiration date indicated on the package label.

Principle

  • AffiVET® Feline Coronavirus Ag Test Kit utilizes Chromatographic Immunoassay technology to qualitatively detect Feline Coronavirus (FCoV) antigen in feline feces.
  • This kit features two lines on its surface: the test (T) line and the control (C) line. The control line serves as a reference to confirm proper test performance and must appear consistently after the test is conducted. In the presence of FCoV antigens in the sample, a purple test line will manifest in the result window.
  • Highly selective antibodies to FCoV are employed as both capture and detector agents in the assay. These antibodies demonstrate remarkable accuracy in detecting FCoV antigens in feline feces.

Precautions

  1. Use the test kit exclusively for feline specimens; avoid application on other animals.
  2. Conduct the test promptly after removing the test device from the foil pouch, as the device is sensitive to humidity and heat.
  3. Refrain from reusing the disposable dropper.
  4. Apply the sample using the disposable dropper vertically.
  5. Avoid touching the membrane in the result window of the test device.
  6. Adhere strictly to the stated expiration date marked on the package label; do not use the test kit beyond this date.
  7. Discard the test kit if the pouch is damaged or the seal is broken.
  8. Do not mix components from different lot numbers, as the components have undergone quality control testing as standard batch units.
  9. Handle all samples as potentially infectious; wear protective gloves during sample manipulation and wash hands thoroughly afterward.
  10. Ensure safe decontamination and disposal of all samples, used kits, and potentially contaminated materials in compliance with national and local regulations.
  11. While the AffiVET® FCoV Ag Test Kit provides a simple and swift measurement of Feline Coronavirus (FCoV) antigen in feline feces, differences in detection performance may exist compared to other clinical or laboratory methods employing more sophisticated principles.

Sample

Collection & Preparation

  1. Use feline feces exclusively as sample for this test.
  2. Test the samples immediately after collection.
  3. If immediate testing isn’t possible, store the samples at 2~8°C for up to 24 hours. For longer storage periods, freeze the samples at -20°C or below.
  4. Ensure to use the appropriate amount of fecal swab as indicated in the provided picture. Excessive fecal material may lead to false positive results and slow migration.

Test Procedure

  1. Ensure all reagents and samples are at room temperature (15~30°C) before use.
  2. Collect fecal samples using a swab.
  3. Insert the swab into the assay diluent tube and mix until the sample is dissolved into the assay diluent (approximately 10 sec.).
  4. Recap the sample tube and mix it by inverting it 3~5 times.
  5. Allow for 1 minute to settle down the large particles.
  6. Remove the test device from the foil pouch and place it on a flat, dry surface.
  7. Using the disposable dropper, extract the supernatant sample from the tube.
  8. Apply 4~5 drops of the mixed sample into the sample hole, drop by drop vertically.
  9. Initiate the timer. The sample will migrate across the result window. If it fails to appear after 1 minute, add one more drop of mixed sample to the sample hole.
  10. Interpret test results precisely at 10 minutes. Avoid reading the result after 20 minutes.

Result Interpretation

  • Negative Result
    Only control (“C”) line appears in the result window.

  • Positive Result
    The presence of FCoV antigen is indicated by the appearance of the Test (“T”) line and Control (“C”) line within the result window.

  • Invalid Result
    The absence of the control (“C”) line may render the result invalid. It is recommended to retest the sample in such cases.

Limitations

  1. While the AffiVET® FCoV Ag Test Kit is highly accurate in detecting Feline Coronavirus antigen, a low incidence of false results can be occurred. Other clinical 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. The detection limit of this kit is about 1.97×104.0 TCID50/ml.
  2. The reading window may exhibit a light pink background coloration, which will 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.

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References

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