Migi (Dog) CDV-AgCanine Distemper Virus Antigen Rapid Quantitative Test Kit

SPECIFICATION

10 Tests/Box

Cat. No.: MG-CA-R001

INTENDED USE
The CDV-Ag test is a fluorescence immunoassay designed for use with an Immunofluorescence Analyzer to quantitatively measure distemper virus antigen (CDV-Ag) in canine nasopharyngeal or ocular swabs. It is used to aid in diagnosing and monitoring canine distemper virus infections.

For in vitro diagnostic use only. For professional use only.

TEST PRINCIPLE

This test uses a quantitative double antibody sandwich fluorescence immunoassay technique. The intensity of the fluorescent signal reflects the amount of CDV-Ag captured, with the concentration expressed as Tu/ml.

MATERIALS

Materials Provided
Each box contains:

1. 10 individual sealed pouches, each containing:

• Test Device

• Desiccant pouch

1. 1 ID Chip

2. Instructions for Use

3. 10 cotton swabs

4. 10 tubes of CDV-Ag Sample Buffer

5. 10 Pipette Tips

Materials Required but Not Provided

1. Immunofluorescence Analyzer

2. Timer

3. Pipette

4. Centrifuge

STORAGE AND STABILITY

• Store the test kit between 4°C and 30°C until the expiration date.

• After opening the Test Device, operate the test between 18°C and 28°C.

• Perform the test within 30 minutes of opening the pouch.

SPECIMEN COLLECTION AND PREPARATION

The test can be performed using a rectal swab.
Rectal sample collection:

• Insert the swab into the canine's rectum and rotate close to the inner wall 3–5 times to collect a sample (about 1/2 to 2/3 of the cotton tip).

• Perform the test immediately after collection. If the test cannot be performed within 3 hours, store the sample at 2°C to 8°C for no more than 48 hours. For long-term storage, freeze at -20°C or lower.

• Bring all materials to room temperature before testing. Thaw frozen specimens completely and mix well. Avoid repeated freeze-thaw cycles.

TEST PROCEDURE

Refer to the Immunofluorescence Analyzer Operation Manual for detailed instructions.

1. Place the Test Device on a clean, level surface.

2. Insert the ID Chip into the analyzer and verify that the Test Device lot number matches the ID Chip.

3. Place the rectal swab with the sample into the CDV-Ag Sample Buffer, stir thoroughly, and centrifuge for 1 minute (3,000–5,000 rpm).

4. Pipette 100 μl of the mixed sample into the sample well (S) of the Test Device, avoiding bubbles.

Test Mode Options:
a) Standard Test: Select "Standard Test," insert the Test Device into the meter after adding the sample, and click "Start Test." Select the sample type "Rectal Swab." The meter will automatically read and display the result.
b) Quick Test: Select "Quick Test," start the timer after adding the sample, and allow the Test Device to sit at room temperature for 10 minutes. Then insert the Test Device into the meter and click "Start Test." Select "Rectal Swab" as the sample type.

Results will be displayed on the main screen and printed automatically or manually by selecting "Print."

QUALITY CONTROL

Each CDV-Ag Rapid Quantitative Test includes an internal control for routine quality checks. If the internal control fails, the meter will display an error message, indicating that a new test should be performed.

INTERPRETATION

Detection range: 4.0 ~ 640 Tu/ml
Reference range:

• ≤8 Tu/ml: Negative (-)

• 8–15 Tu/ml: Suspected (±)

• 15–40 Tu/ml: Weak Positive (+)

• 40–200 Tu/ml: Medium Positive (++)

• 200 Tu/ml: Strong Positive (+++)

Each laboratory should establish a reference range suited to the population being tested.

WARNINGS AND LIMITATIONS

• For in vitro diagnostic use only.

• Inspect packaging and labels before use. Do not use if the pouch is damaged or the vial is leaking.

• Do not use the Test Device beyond the expiration date.

• Use a separate pipette tip for each specimen.

• Factors such as technical or procedural errors, and substances not listed, may interfere with results.