Key attributes
SPECIFICATION
Package Size: 10 Tests/Box
Catalog Number: MG-CA-R017
The cTSH test is a fluorescence immunoassay designed for use with an Immunofluorescence Analyzer to quantitatively measure thyroid-stimulating hormone (TSH) levels in canine serum or plasma. This test is intended for professional use only and for in vitro diagnostic purposes.
Utilizes a quantitative double antibody sandwich fluorescence immunoassay technique.
The fluorescent signal intensity correlates with the amount of cTSH captured, with results expressed in mIU/L.
| Contents | Quantity |
|---|---|
| Individual Sealed Pouches | 10 |
| - Test Device | Per pouch |
| - Desiccant Pouch | Per pouch |
| ID Chip | 1 |
| Instructions for Use | 1 |
| cTSH Sample Buffer Tubes | 10 |
| Pipette Tips | 10 |
Materials Required but Not Provided:
| Equipment | Quantity |
|---|---|
| Immunofluorescence Analyzer | 1 |
| Timer | 1 |
| Pipette | 1 |
| Centrifuge | 1 |
Store the test kit at 4–30℃ until the expiration date.
After opening, operate the test at 18–28℃.
Perform the test within 30 minutes of opening the pouch.
The test can be performed on serum or plasma (EDTA anticoagulant recommended).
Separate serum or plasma from blood within 3 hours of collection. If the specimen is severely hemolyzed, obtain a new specimen.
Perform the test as soon as possible after collection. If not feasible, store the specimen at 2–8℃ for up to 72 hours or below -20℃ for long-term storage.
Bring all materials to room temperature before use. Ensure frozen specimens are fully thawed and mixed well before testing. Avoid repeated freezing and thawing. Use only clear, non-hemolyzed specimens.
Refer to the Immunofluorescence Analyzer Operation Manual for detailed instructions.
Place the Test Device on a clean, level surface.
Insert the ID Chip into the analyzer and click "Read ID Chip." Verify that the Test Device lot number matches the ID Chip number.
Pipette 50 μl of prepared sample into the cTSH Sample Buffer and mix gently, avoiding vigorous agitation and foaming.
Pipette 100 μl of the mixed sample into the sample well (S) of the Test Device, avoiding bubbles.
Choose the Test Mode:
Standard Test: Click "Standard Test," insert the Test Device into the analyzer immediately after adding the sample, select "Serum/Plasma," and start the test. The meter will automatically read and display the result.
Quick Test: Click "Quick Test," start the timer after adding the sample mixture, and incubate the Test Device at room temperature for 10 minutes. Insert the device into the analyzer and select "Serum/Plasma," then start the test. The result will be displayed automatically.
Results are shown on the screen and can be printed either automatically or by clicking "Print."
Each cTSH Rapid Quantitative Test includes an internal control for quality assurance. If the internal control fails, the analyzer will show an error message, indicating a need for a retest.
Detection Range: 9.0 ~ 600 mIU/L
| Result (mIU/L) | Significance |
|---|---|
| ≤ 37 | Normal |
| > 37 | High |
Each laboratory should establish its own reference range based on the specific population being tested.
For in vitro diagnostic use only.
Inspect packaging and labels before use. Do not use if the pouch is damaged or the vial is leaking.
Do not use the test device past the expiration date.
Use one pipette tip per specimen to avoid cross-contamination.
Technical or procedural errors, as well as substances not listed in the instructions, may interfere with the test and produce erroneous results.
