AFFIGEN AFG-VR-20 Affivet Rapid Test Kit Instruction Manual

**AFFIGEN AFG-VR-20 Affivet Rapid Test Kit Instruction Manual

**

Material Required

• (10) Rapid Canine Corona virus Antigen Test Device
• (10) Assay Diluent Tube
• (10) Disposable Swab
• (10) Disposable Dropper
• (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® Rapid CCV Ag Test Kit is a chromatographic immunoassay designed for the qualitative detection of Canine Corona virus(CCV) antigen in canine feces.
• This kit is equipped with two distinct lines on the device’s surface, namely the test (T) line and the control (C) line, which are initially invisible in the result window until a sample is applied. The control line serves as a crucial reference, confirming the test’s proper execution and is expected to appear with every test conducted. Presence of CCV antigens in the sample will result in the emergence of a purple test line within the result window.
• To ensure high sensitivity and specificity, the assay employs highly selective antibodies against CCV, functioning both as capture and detector elements. These antibodies are adept at identifying CCV antigens in canine feces, thereby ensuring the assay’s high accuracy

Precautions

1. This test kit is exclusively designed for use in canine. It is not suitable for testing other animals.
2. The test device is sensitive to both humidity and heat. To ensure accuracy, initiate the test promptly after removing the device from its protective foil pouch.
3. The components of this test kit are single-use only and should not be reused under any circumstances.
4. When applying the sample, use the provided disposable dropper and hold it vertically to ensure precision.
5. Avoid making contact with the membrane located in the result window of the test device to prevent contamination or damage.
6. Do not use the test kit after its expiration date, which is clearly indicated on the package label, to guarantee the reliability of results.
7. If the pouch is damaged or the seal has been tampered with, do not use the test kit as its sterility and integrity may be compromised.
8. Refrain from interchanging components between kits of different lot numbers. Each kit’s components have undergone quality control testing as a complete unit to ensure their performance.
9. Treat all samples as potentially infectious. Protective gloves should be worn during sample handling, and hands should be washed thoroughly afterward.
10. Follow national and local guidelines for the safe decontamination and disposal of all samples, used kits, and any materials that might be contaminated to ensure environmental safety and health protection.

Sample Collection & Preparation

1. Utilize a canine feces swab for this test.
2. Test samples immediately after collection.
3. If immediate testing isn’t possible, store samples at 2 to 8°C for 24 hours. For longer storage, freeze at -20°C or below. Prior to use, thaw frozen samples to room temperature (15 to 30°C).
4. Ensure the correct amount of fecal material on the swab as depicted in the accompanying image. Excessive fecal matter may lead to false positive results and hinder migration.

• Not enough

• Good

• Good

• Too Much

Test Procedure

1. Ensure all reagents and samples are brought to room temperature (15~30°C) before use.

2. Collect fecal samples using a swab.

3. Insert the swab into the assay diluent tube and thoroughly mix until the sample is dissolved into the diluent (approximately 10 seconds).

4. Allow the mixture to settle for 1 minute to allow large particles to precipitate.

5. Remove the test device from the foil pouch and place it on a flat, dry surface.

6. Using the disposable dropper, transfer the supernatant sample from the tube.

7. Add 4 drops of the mixed sample into the sample hole(s), dropping vertically.

8. Begin the timer and allow the sample to flow across the result window. If no flow is observed after 1 minute, add one additional drop of the mixed sample to the sample hole.

9. Interpret test results at 5- 10 minutes. Do not read the results after 20 minutes.

Result Interpretation

• Negative Result

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

• 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 Rapid CCV Ag Test kit is highly accurate in detecting Canine Coronavirus antigen, occasional false results may occur. In cases of uncertainty, additional clinically or laboratory tests may be necessary. It is important to note that definitive clinical diagnosis should not rely solely on the results of a single test but should be made by the veterinarian after considering all clinical and laboratory findings.
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.

Contact us

Phone : 800-660-1620
Email : info@affigen.com
Website : www.affigen.com

Read User Manual Online (PDF format)

Read User Manual Online (PDF format)  >>

Download This Manual (PDF format)

Download this manual  >>