AffiVET® Canine Distemper Virus CDV Antibody Rapid Test Kit

Test Principal:

The AffiVET® Canine Distemper Virus CDV Antibody Rapid Test Kit employs a chromatographic immunoassay method for the semi-quantitative detection of IgG antibodies specific to the distemper virus in canine serum, plasma, or whole blood.

Meanwhile, the AffiVET® Canine Distemper Virus CDV Antibody Rapid Test Kit is designed with two lines on its surface: the "T" line (test line) and the "C" line (control line). Before sample application, these lines remain invisible. The control line serves as a reference, indicating proper test functionality by appearing consistently. In the result window, the emergence of a purple test line indicates the presence of target antibodies in the sample.

This test utilizes highly selective antigens, functioning both as capture and detector agents. These antigens possess remarkable accuracy in identifying IgG antibodies specific to the canine distemper virus within the sample.

Material Required:

(10) Rapid Canine Distemper Virus CDV Antibody Test Device
(10) Assay Diluent Tube
(10) Disposable inverted cup (5 μl)
(10) Sample sheet
(10) Anticoagulant tube
(10) Disposable Dropper
(01) Color scale (1~6) measurement
(01) Instruction of Use
(01) Timer (Not Provided)
(01) Micropipette (Not Provided)

Storage & Stability:

1) Store the test kit at 2~30 °C. 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.

Sample collection & Preparation:

1. This test requires canine whole blood, serum, or plasma.

• Whole Blood:

Collect up to 1.5 ml of whole blood in the provided anticoagulant tube. It's best to use the anticoagulated whole blood immediately. If immediate testing isn't possible, you can store samples at room temperature for up to four hours from collection, or up to 24 hours if refrigerated at 28°C (35.646.4°F).

• Serum:

Collect whole blood in a tube without anticoagulants like heparin, EDTA, or sodium citrate. Let it sit for 30 minutes to allow coagulation, then centrifuge to obtain serum.

• Plasma:

Collect whole blood in a tube with anticoagulants such as heparin, EDTA, or sodium citrate, then centrifuge to obtain plasma.

2. Plasma and serum can be stored at 28°C (35.6~ 46.4°F) for up to two weeks. For longer storage, freeze them at -20°C (-4°F) or below for up to one year. Before use, thaw frozen samples to room temperature (15~30°C).

3. To avoid inconsistent test results, clarify samples containing precipitate before assaying.

4. Hemolyzed samples can cause nonspecific reactions. Use whole blood within 24 hours of collection. For extended storage, separate serum from whole blood and freeze it.

Test Procedure:

1. Ensure all kit components and samples are at room temperature (15~30 °C) before testing.
2. Open the foil pouch and remove the test kit.
3. For whole blood samples:

Drop it in the sample sheet then collect 5 μl of sample using inverted cup. The whole blood will be automatically collected into the inverted cup by surface tension.

    For the Serum/Plasma:

Collect 5 μl of sample using micropipette .

4. Transfer the collected sample into the assay diluent tube.
5. Close the tube cap securely and mix the sample thoroughly until it completely dissolves into the assay diluent.
6. Use the provided disposable dropper to transfer the prepared samples into the tube.
7. Add 4 drops of the sample into the designated sample hole, dropping them vertically.
8. Start the timer. The sample will flow across the result window in 4~5 minutes. If it doesn't appear within 1 minute, add one more drop of prepared sample.
9. Interpret the test results after 10 minutes. Do not interpret results after 20 minutes.

1) Compare the color development on the control ("C") line with color scale and fix it to
the scale '3'.
2) Interpret the color intensity of the Test line.

Result Interpretation:

Negative result:

Presence of C-Line

Absence of T-Line

Positive result:

Low titer (Below 1:4 as VN titer):
The color development of Test (“T”) line is weaker than that of Control ("C") line. (Color
scale 1~2).

Medium Titer (1:8 as VN titer):
The Test (“T”) line has equal color development with Control ("C") lines. (Color scale 3).

High Titer (Above 1:16 as VN titer):
The color development of Test (“T”) line is higher than that of Control ("C") line. (Color
scale 4~6).

Invalid Result:

Absence of C-Line
Presence of T-Line

Or

Absence of C-Line
Absence of T-Line

This means that the procedure was not applied correctly or that the test is invalid.

Test Limits:

1. While the AffiVET® Canine Distemper Virus CDV Antibody Rapid Test Kit is highly accurate in detecting IgG to the Canine Distemper virus, there is a low incidence of potential false results. If questionable results are obtained, it may be necessary to conduct additional clinical and/or laboratory tests. Like with any diagnostic test, a definitive clinical diagnosis should not rely solely on the result of a single test but should be made by a veterinarian after evaluating all clinical and laboratory findings.
2. Please note that the reading window may display a light pink background coloration; however, this does not impact the accuracy of the results.
   
3. It's important to understand that AffiGEN Inc. and its distributors cannot be held responsible for any consequences arising from the misuse or misinterpretation of the test results.