Migi (Cat) Feline Panleukopenia Virus Antigen (FPV-Ag) Rapid Quantitative Test Kit

SPECIFICATION
10 Tests/Box

Catalog No.: MG-CA-R006

INTENDED USE
The FPV-Ag test is a fluorescence immunoassay designed for use with an Immunofluorescence Analyzer to quantitatively measure panleukopenia virus antigen (FPV-Ag) concentration in feline rectal swabs. It serves as an aid 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 utilizes a quantitative double antibody sandwich fluorescence immunoassay technique.

2. The intensity of the fluorescent signal corresponds to the amount of FPV-Ag captured, with concentration expressed in Tu/ml.

MATERIALS PROVIDED

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.

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

SPECIMEN COLLECTION AND PREPARATION

• The test is performed using a rectal swab.

• Collection of rectal sample: Insert the swab into the feline's rectum and rotate it against the inner wall 3–5 times to collect a sample (approximately 1/2 to 2/3 of the cotton tip).

• Ideally, perform the test immediately after specimen collection. If testing cannot be done within 3 hours, store the specimen at 2–8°C for up to 48 hours. For long-term storage, freeze the specimen below -20°C.

• Bring all materials to room temperature before use. Thaw frozen specimens completely and mix well before testing. Avoid repeated freezing and thawing. Use only clear, non-hemolyzed specimens.

TEST PROCEDURE
Refer to the Immunofluorescence Analyzer Operation Manual for detailed instructions on using the Test Device.

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. Place the rectal swab with the sample into the FPV-Ag Sample Buffer. Stir thoroughly and centrifuge for 1 minute at 3000–5000 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 holder immediately after adding the sample, and click "Start Test." Choose the sample type "Rectal Swab." 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." Choose the sample type "Rectal Swab." The meter will automatically read the result.

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

QUALITY CONTROL
Each FPV-Ag 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.

INTERPRETATION
Reference Range of FPV-Ag in Feline Rectal Swab:

• Detection Range: 4.0–640 Tu/ml

Reference Range:

Each laboratory should establish a reference range that is appropriate for the population being tested.

WARNINGS AND LIMITATIONS OF THE PROCEDURE

• This kit is for in vitro diagnostic use only.

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

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

• Use a new pipette tip for each specimen to avoid cross-contamination.