Migi (Cat) Feline Panleukopenia Virus Antibody (FPV-Ab) Rapid Quantitative Test

SPECIFICATION10 Tests/Box

Catalog No.: MG-CA-R011

INTENDED USEThe FPV-Ab test is a fluorescence immunoassay intended for use with an Immunofluorescence Analyzer to quantitatively determine the concentration of panleukopenia virus antibodies (FPV-Ab) in serum or plasma. This test can be used to assess the level of FPV-Ab titer following pet vaccination, helping to determine whether a booster vaccination is necessary. Additionally, it aids in the diagnosis and monitoring of feline panleukopenia virus infection.

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

TEST PRINCIPLE

1. The test uses a quantitative double antigen sandwich fluorescence immunoassay technique.

2. The intensity of the fluorescent signal is proportional to the amount of FPV-Ab captured, and the concentration is expressed as Tu/ml.

MATERIALS PROVIDED

Materials Required But Not Provided:

• Immunofluorescence Analyzer

• Timer

• Pipette

• Centrifuge

STORAGE AND STABILITY

• Store the test kit at 4–30°C until the expiration date.

• Operate the test between 18–28°C after opening the Test Device.

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

SPECIMEN COLLECTION AND PREPARATION

• The test is suitable for serum or plasma (EDTA anticoagulant recommended).

• Separate serum or plasma from blood within 3 hours of collection. Avoid using severely hemolyzed specimens; obtain a new sample if necessary.

• Perform the test immediately after specimen collection. If not possible, store the specimen at 2–8°C for up to 72 hours. For long-term storage, freeze specimens below -20°C.

• Bring all materials to room temperature before use. Thaw frozen specimens completely and mix well. Do not refreeze specimens after thawing. Only use clear, non-hemolyzed specimens.

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 meter, and select “Read ID chip” to ensure the Test Device lot number matches the ID Chip number.

3. Pipette 20 μl of the prepared sample into the FPV-Ab Sample Buffer and mix gently, avoiding vigorous agitation and foaming.

4. Add 100 μl of the mixed sample to the sample well (S) of the Test Device, ensuring no bubbles form.

Test Mode Options:a) Standard Test: Select "Standard Test," insert the Test Device into the meter holder immediately after adding the sample, and click "Start Test." Choose the sample type "Serum/Plasma." The meter will automatically read the result after counting down.

b) Quick Test: Select "Quick Test," start the timer immediately after adding the sample to the well, and leave the Test Device at room temperature (18–28°C) for 10 minutes. Insert the device into the meter holder and click "Start Test." Select the sample type "Serum/Plasma." The meter will scan the device and display the result.

• Results are displayed on the main screen, printed automatically, or by clicking "Print."

QUALITY CONTROLEach FPV-Ab Rapid Quantitative Test includes an internal control for quality assurance. This internal control is conducted with each patient sample test. If an invalid result occurs, the meter will display an error message, indicating the need for a retest.

INTERPRETATIONReference Range of FPV-Ab in Canine Serum or Plasma:

• Detection Range: 4.5–640 Tu/ml

Reference Range:

Note: If the pet has not been vaccinated but shows a level above 1, it may indicate past infection.

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

WARNINGS AND LIMITATIONS OF THE PROCEDURE

• For in vitro diagnostic use only.

• Inspect the packaging and labels before use; do not use if the pouch is damaged or the vial leaks.

• Do not use the test device beyond the expiration date.

• Use a new pipette tip for each specimen.

• Test results may be affected by technical or procedural errors, as well as unlisted substances in blood specimens.