Key attributes
SPECIFICATION
10 Tests/Box
Catalog No.: MG-CA-R023
INTENDED USE
The fTT4 test is a fluorescence immunoassay designed for use with an Immunofluorescence Analyzer to quantitatively determine total thyroxine (fTT4) concentration in feline serum or plasma. This test aids in evaluating thyroid function.
For in vitro diagnostic use only. For professional use only.
TEST PRINCIPLE
This test utilizes a quantitative competitive fluorescence immunoassay technique.
The intensity of the fluorescent signal corresponds to the amount of fTT4 captured, with concentration expressed in nmol/L or µg/dL.
MATERIALS PROVIDED
| Material Provided | Material Required But Not Provided |
|---|---|
| Each box contains: | |
| 1. 10 individual sealed pouches, each containing: | 1. Immunofluorescence Analyzer |
| – a Test Device | 2. Timer |
| – a desiccant pouch | 3. Pipette |
| 2. One ID Chip | 4. Centrifuge |
| 3. Instructions for Use | |
| 4. 10 cotton swabs | |
| 5. 10 tubes of fTT4 Sample Buffer | |
| 6. 10 Pipette tips |
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 serum or plasma specimens.
Separate serum or plasma (EDTA anticoagulant is 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 testing cannot be done within 3 hours, store the specimen at 2–8°C for up to 72 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.
Place the Test Device on a clean, level surface.
Insert the ID Chip into the meter and select "Read ID chip" to ensure the Test Device lot number matches the ID Chip number.
Pipette 50 μl of the prepared sample into the fTT4 Sample Buffer and gently mix. Avoid vigorous agitation and foaming.
Pipette 100 μl of the mixed sample into the sample well 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." 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 15 minutes. Insert the device into the meter holder and click "Start Test." 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 fTT4 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 fTT4 in Feline Serum or Plasma:
Detection Range: 5.0–960 nmol/L (1 nmol/L = 0.0777 μg/dL)
Reference Range:
| Result (nmol/L) | Result (µg/dL) | Interpretation |
|---|---|---|
| ≤ 15 | ≤ 1.17 | Low |
| 15–50 | 1.17–3.89 | Normal |
| > 50 | > 3.89 | High |
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.
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.
