Notice: You need an Immunofluorescence Analyzer to run the tests with this kit
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SPECIFICATION
10 Test/Box
Cat.No.:MG-CA-R030
INTENDED USE
The fCys C test is a fluorescence immunoassay used along with an Immunofluorescence Analyzer for quantitative determination of cystatin C concentration in feline serum or plasma. This test is used to diagnose and monitor the renal failure of feline.
For in vitro diagnostic use only. For professional use only.
TEST PRINCIPLE
- This test employs a quantitative double antibody sandwich fluorescence immunoassay technique.
- The fluorescent signal intensity reflects the amount of fCys C captured. The concentration is expressed as mg/dL.
MATERIAL
| Material Provided | Material Required But Not Provided |
|---|---|
| 10 individual sealed pouches, each containing: <br> ■ Test Device <br> ■ Desiccant pouch | 1. Immunofluorescence Analyzer |
| One ID Chip | 2. Timer |
| Instructions for Use | 3. Pipet |
| 10 tubes of fCys Sample Buffer | 4. Mesin sentrifugal |
| 10 Tip pipet |
STORAGE AND STABILITY
- Store the test kit at 4～30℃ up to the expiration date.
- The test should operate at 18 ~ 28℃ after the Test Device opening.
- Once the pouch is opened, the test should be performed within 30 menit.
SPECIMEN COLLECTION AND PREPARATION
The test can be performed with serum or plasma.
- Separate serum or plasma (EDTA anticoagulant is recommended) from blood within 3 jam after blood collection. If a specimen appears to be severely hemolyzed, another specimen should be obtained and tested.
- Optimally, the test should be performed immediately after the specimen collection. If the test cannot be performed within 3 jam after blood collection, store the specimen at 2～8℃ for no longer than 72 jam. For long-term storage, specimens shall be kept below -20℃.
Bring all materials to room temperature before use. Frozen specimens must be completely thawed and mixed well prior to testing. Specimens should not be frozen and thawed repeatedly. Only clear, non-hemolyzed specimens can be used.
TEST PROCEDURE
Refer to the Immunofluorescence Analyzer Operation Manual for complete instructions for the use of the Test device.
- Set a Test Device on a clean, level horizontal table.
- Insert the ID Chip into the meter, and click “Read ID chip”. Make sure that the Test Device lot No. matches with ID Chip No.
- Pipet 50 Maku of prepared sample into fCys C Sample Buffer, and gently mix well. Vigorous agitation and foaming should be avoided.
- Pipet 100 Maku of mixed sample to add into the sample well (S) of the test device. Avoid forming bubbles.
- Test mode: a or b
A) Standard Test: Click “Standard Test”, insert the Test Device into the device holder of the meter right after adding the sample to the sample well, and click “Start Test”. Select Sample type “Serum/Plasma”. The meter will start to countdown and read the test result automatically.
b) Quick Test: Click “Quick Test”, Dan start the timer right after adding the sample mixture to the sample well. Leave the Test Device at room temperature (18 ~ 28℃) untuk 10 menit. Kemudian insert the test device immediately into the holder of the meter and click “Start Test”. Select Sample type “Serum/Plasma”. The instrument will scan the Test Device automatically and show the test result.
- Results are displayed on the main screen, print automatically, or be printed by clicking “Print”.
QUALITY CONTROL
Each fCys C Rapid Quantitative Test contains an internal control for routine quality control requirements. This internal quality control is performed each time a patient sample is tested, If an invalid result from the internal control occurs, the meter will display an error message, indicating that another test should be conducted.
INTERPRETATION
Reference range of fCys C in feline serum or plasma.
- Detection range: 3.5 ~ 50mg/dL
- Conversion factor: 1mg/dL=0.1mg/L
- Reference range:
| Produk | Hasil (mg/dL) | Signification |
|---|---|---|
| fCys C | ≤ 7.0 | Negatif (-) |
| 7.0 ~ 10 | Suspected kidney injury (+) | |
| > 10 | Indicated kidney injury (++) |
Each laboratory should establish a reference range that is representative of the population to be evaluated.
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 it if the pouch is broken, torn, or not well sealed, or if the vial looks damaged or leaked.
- Do not use the test device beyond the expiration date.
- One pipette tip should be used for one specimen only.
- There is the possibility that factors such as technical or procedural errors, as well as additional substances in blood specimens that are not listed in the text, may interfere with the test and cause erroneous results.
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