Key attributes
SPECIFICATIONS
10 Tests/Box
Cat.No.: MG-CA-R030
The fCys C test is a fluorescence immunoassay designed for use with an Immunofluorescence Analyzer to quantitatively determine cystatin C concentration in feline serum or plasma. It is intended for diagnosing and monitoring renal failure in felines.
For in vitro diagnostic use only. For professional use only.
This test employs a quantitative double antibody sandwich fluorescence immunoassay technique. The intensity of the fluorescent signal reflects the amount of fCys C captured, with concentration expressed in mg/dL.
10 individual sealed pouches, each containing:
Test Device
Desiccant pouch
1 ID Chip
Instructions for Use
10 tubes of fCys Sample Buffer
10 Pipette tips
Immunofluorescence Analyzer
Timer
Pipette
Centrifuge
Store the test kit at 4–30°C until the expiration date.
Operate the test at 18–28°C after opening the Test Device.
Once the pouch is opened, the test should be performed within 30 minutes.
The test can be performed with serum or plasma.
Separate serum or plasma (EDTA anticoagulant recommended) from blood within 3 hours of collection. If the specimen is severely hemolyzed, obtain a new specimen.
Ideally, perform the test immediately after specimen collection. If the test cannot be performed within 3 hours, store the specimen at 2–8°C for no longer than 72 hours. For long-term storage, keep specimens below -20°C.
Bring all materials to room temperature before use. Thaw and mix frozen specimens thoroughly before testing. Do not refreeze specimens multiple times. Use only clear, non-hemolyzed specimens.
Refer to the Immunofluorescence Analyzer Operation Manual for detailed instructions.
Set a 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 50 μl of the prepared sample into the fCys C Sample Buffer and mix gently. Avoid vigorous agitation and foaming.
Pipette 100 μl of the mixed sample into the sample well (S) of the Test Device. Avoid forming bubbles.
Test Modes:
Standard Test: Click "Standard Test," insert the Test Device into the holder right after adding the sample, and click "Start Test." Select sample type "Serum/Plasma." The meter will automatically countdown and display the test result.
Quick Test: Click "Quick Test" and start the timer immediately after adding the sample mixture. Leave the Test Device at room temperature (18–28°C) for 10 minutes. Then, insert the Test Device into the holder and click "Start Test." Select sample type "Serum/Plasma." The instrument will automatically scan and display the test result.
Results are displayed on the main screen and can be printed automatically or manually by clicking "Print."
Each fCys C Rapid Quantitative Test contains an internal control for routine quality assurance. This control is performed with each patient sample. If the internal control fails, the meter will display an error message, indicating the need to conduct a new test.
Reference Range for fCys C in Feline Serum or Plasma:
Detection Range: 3.5–50 mg/dL
Conversion Factor: 1 mg/dL = 0.1 mg/L
| Result (mg/dL) | Interpretation |
|---|---|
| ≤ 7.0 | Negative (-) |
| 7.0–10 | Suspected kidney injury (+) |
| > 10 | Indicated kidney injury (++) |
Each laboratory should establish a reference range representative of the population being evaluated.
This kit is for in vitro diagnostic use only.
Inspect the packaging and labels before use. Do not use if the pouch is damaged or if the vial is compromised.
Do not use the Test Device beyond the expiration date.
Use one pipette tip per specimen to avoid contamination.
Note that technical or procedural errors, as well as substances in blood specimens not listed, may interfere with the test and cause erroneous results.
