Key attributes
SPECIFICATIONS
10 Tests/Box
Cat.No.: MG-CA-R027
The FIV-Ab test is a fluorescence immunoassay designed for the quantitative determination of feline immunodeficiency virus antibodies in serum or plasma specimens. This test assists in diagnosing and monitoring feline immunodeficiency virus (FIV) infection.
For in vitro diagnostic use only. For professional use only.
This test uses a quantitative double antigen sandwich fluorescence immunoassay technique. The intensity of the fluorescent signal corresponds to the amount of FIV-Ab captured, with the concentration expressed as Tu/ml.
10 individual sealed pouches, each containing:
Test Device
Desiccant pouch
1 ID Chip
Instructions for Use
10 cotton swabs
10 tubes of FIV-Ab Sample Buffer
10 Pipette tips
Immunofluorescence Analyzer
Timer
Pipette
Centrifuge
Store the test kit at 4–30°C until the expiration date.
Perform the test at 18–28°C after opening the Test Device.
Once the pouch is opened, the test should be completed within 30 minutes.
The test can be performed using serum or plasma.
Serum/Plasma Preparation: Separate serum or plasma (EDTA anticoagulant is recommended) from blood within 3 hours of collection. If the specimen is severely hemolyzed, a new specimen should be obtained.
Ideally, the test should be performed immediately after specimen collection. If testing cannot be completed within 3 hours, store the specimen at 2–8°C for up to 72 hours. For long-term storage, specimens should be kept below -20°C.
Preparation for Testing:
Bring all materials to room temperature before use.
Thaw and mix frozen specimens thoroughly prior to testing.
Avoid repeated freezing and thawing of specimens.
Use only clear, non-hemolyzed specimens.
Refer to the Immunofluorescence Analyzer Operation Manual for complete instructions.
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 50 μl of the prepared sample into the FIV-Ab Sample Buffer and mix gently. Avoid vigorous agitation and foaming.
Pipette 100 μl of the mixed sample into the sample well of the Test Device, ensuring no bubbles form.
Test Modes:
Standard Test: Click "Standard Test," insert the Test Device into the meter holder immediately after adding the sample, and click "Start Test." The meter will automatically countdown and display the result.
Quick Test: Click "Quick Test," start the timer immediately after adding the sample mixture, and leave the Test Device at room temperature (18–28°C) for 15 minutes. Then, insert the Test Device into the meter holder and click "Start Test." The instrument will automatically scan and display the result.
Results are displayed on the main screen and can be printed automatically or manually by clicking "Print."
Each FIV-Ab Rapid Quantitative Test includes an internal control to ensure routine quality control. This internal control is performed with each patient sample. If the internal control fails, the meter will display an error message, indicating the need for a repeat test.
Reference Range for FIV-Ab in Feline Serum or Plasma:
Detection Range: 4.5–320 Tu/ml
| Result (Tu/ml) | Interpretation |
|---|---|
| ≤ 9 | Negative (-) |
| 9–11 | Suspected (±) |
| 11–20 | Weak Positive (+) |
| 20–100 | Medium Positive (++) |
| > 100 | Strong Positive (+++) |
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 appears compromised.
Do not use the Test Device beyond the expiration date.
Use a new pipette tip for each specimen to avoid contamination.
Be aware that technical or procedural errors, as well as substances in specimens not listed, may interfere with the test and result in erroneous outcomes.
