Key attributes
SPECIFICATION
10 Tests/Box
Cat. No.: MG-CA-R013
INTENDED USE
The FCV-Ab test is a fluorescence immunoassay designed for use with an Immunofluorescence Analyzer to quantitatively determine the concentration of feline calicivirus antibody in serum or plasma. The test may serve as a reference for FCV-Ab titer levels following vaccination and help determine if additional immunization is needed. It can also assist in the diagnosis and monitoring of feline calicivirus infection.
For in vitro diagnostic use only. For professional use only.
TEST PRINCIPLE
The test utilizes a quantitative double antigen sandwich fluorescence immunoassay technique.
The fluorescent signal intensity reflects the amount of FCV-Ab captured, with concentration expressed as Tu/ml.
MATERIALS
Contents
Individual Sealed Pouches: 10
Test Device (per pouch)
Desiccant Pouch (per pouch)
ID Chip: 1
Instructions for Use: 1
FCV-Ab Sample Buffer Tubes: 10
Pipette Tips: 10
Material Required But Not Provided
Immunofluorescence Analyzer
Timer
Pipette
Centrifuge
STORAGE AND STABILITY
Store the test kit at 4～30℃ until the expiration date.
Operate the test at 18 ~ 28℃ after opening the Test Device.
Perform the test within 30 minutes after opening the pouch.
SPECIMEN COLLECTION AND PREPARATION
The test is performed using serum or plasma.
Separate serum or plasma (EDTA anticoagulant recommended) from blood within 3 hours of collection. If a specimen is severely hemolyzed, obtain and test a new specimen.
Perform the test immediately after specimen collection. If the test cannot be performed within 3 hours, store the specimen at 2 ~ 8℃ for up to 72 hours. For long-term storage, keep the specimen below -20℃.
Bring all materials to room temperature before use. Completely thaw and mix frozen specimens well prior to 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.
Place the Test Device on a clean, level surface.
Insert the ID Chip into the meter and click "Read ID chip." Ensure that the Test Device lot number matches the ID Chip number.
Pipette 20 μl of the prepared sample into the FCV-Ab Sample Buffer and gently mix. Avoid vigorous agitation and foaming.
Pipette 100 μl of the mixed sample into the sample well (S) of the Test Device. Avoid forming bubbles.
Choose one of the following test modes:
Standard Test: Click "Standard Test," insert the Test Device into the meter holder immediately after adding the sample, and click "Start Test." Select the sample type "Serum/Plasma." The meter will automatically count down and display the test result.
Quick Test: Click "Quick Test," start the timer immediately after adding the sample to the sample well, and leave the Test Device at room temperature (18 ~ 28℃) for 10 minutes. Then, insert the Test Device into the meter holder and click "Start Test." Select the sample type "Serum/Plasma." The instrument will automatically scan the Test Device and display the result.
Results can be viewed on the main screen, printed automatically, or manually by clicking "Print."
QUALITY CONTROL
Each FCV-Ab Rapid Quantitative Test includes an internal control for routine quality control. This internal control is performed each time a patient sample is tested. If an invalid result is obtained from the internal control, the meter will display an error message, indicating the need to conduct another test.
INTERPRETATION
Reference range of FCV-Ab in feline serum or plasma:
Detection range: 5.0 ~ 640 Tu/ml
Reference range:
| Result (Tu/ml) | Level | Suggestion |
|---|---|---|
| ≤ 10 | 0 | No antibody protection, vaccination recommended. |
| 10 – 30 | 1 | Weak antibody protection; supplementary immunization or adjustment of the immunization program is recommended. |
| 30 – 90 | 2 | Weak antibody protection; supplementary immunization or adjustment of the immunization program is recommended. |
| 90 – 200 | 3 | Moderate antibody protection; strengthen antibody level monitoring, approximately every 6 months. |
| 200 – 300 | 4 | Moderate antibody protection; strengthen antibody level monitoring, approximately every 6 months. |
| > 300 | 5 | Strong antibody protection; test the antibody level annually to ensure timely vaccine protection. |
Note: If the pet has not been vaccinated but the test results indicate a level above 1, this may suggest a previous infection.
Each laboratory should establish a reference range representative of the population being evaluated.
WARNINGS AND LIMITATIONS
This kit is for in vitro diagnostic use only.
Inspect packaging and labels before use. Do not use if the pouch is broken, torn, not well sealed, or if the vial appears damaged or leaking.
Do not use the test device beyond the expiration date.
Use a new pipette tip for each specimen.
There is a possibility that factors such as technical or procedural errors, as well as additional substances in blood specimens not listed in the instructions, may interfere with the test and cause erroneous results.
