Key attributes
SPECIFICATION
10 Tests/Box
Cat. No.: MG-CA-R029
INTENDED USE
The FCoV-Ag test is a fluorescence immunoassay designed for use with an Immunofluorescence Analyzer to quantitatively determine feline coronavirus antigen concentration in feline rectal swabs. It serves as an aid in the diagnosis and monitoring of feline coronavirus infection.
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 correlates with the amount of FCoV-Ag captured, with the concentration expressed in Tu/ml.
MATERIALS
Material Provided
Test Kit:
Test Device
Desiccant pouch
10 sealed pouches, each containing:
ID Chip
Instructions for Use
10 Cotton Swabs
10 Tubes of FCoV-Ag Sample Buffer
10 Pipette Tips
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 of opening the pouch.
SPECIMEN COLLECTION AND PREPARATION
The test is performed using a rectal swab.
For sample collection: Insert the swab into the feline's rectum and rotate it near the inner wall 3 ~ 5 times. The sample volume should cover about 1/2 ~ 2/3 of the cotton tip.
Perform the test immediately after specimen collection. If testing cannot be done within 3 hours, store the specimen at 2～8℃ for up to 48 hours. For long-term storage, keep the specimen below -20℃.
Before use, bring all materials to room temperature. 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.
Insert the rectal swab with the sample into the FCoV-Ag Sample Buffer. Stir thoroughly and centrifuge for 1 minute (3000 ~ 5000 rpm).
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 "Rectal Swab." The meter will automatically count down and display the test result.
Quick Test: Click "Quick Test," start the timer immediately after adding the sample mixture 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 "Rectal Swab." The instrument will automatically scan the Test Device and display the result.
Results are displayed on the main screen and can be printed automatically or manually by clicking "Print."
QUALITY CONTROL
Each FCoV-Ag Rapid Quantitative Test contains an internal control for routine quality control. This internal control is performed each time a patient sample is tested. If an invalid result occurs, the meter will display an error message, indicating that another test should be conducted.
INTERPRETATION
Reference range of FCoV-Ag in feline rectal swabs:
Detection range: 5.0 ~ 320 Tu/ml
Reference range:
| Result (Tu/ml) | Interpretation | Suggestion |
|---|---|---|
| ≤ 10 | Negative (-) | |
| 10 ~ 12 | Suspected (±) | |
| 12 ~ 20 | Weak Positive (+) | |
| 20 ~ 80 | Medium Positive (++) | |
| > 80 | Strong Positive (+++) |
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.
Technical or procedural errors, as well as other substances in blood specimens not listed in the instructions, may interfere with the test and result in erroneous outcomes.
