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-R020
INTENDED USE
The cProgesterone test is a fluorescence immunoassay used along with an Immunofluorescence Analyzer for the quantitative determination of progesterone concentration in canine serum or plasma specimen.
The clinical applications:
- To determine optimal breeding dates.
- To predict parturition dates or a time for a Cesarean section.
- To detect reproductive disorders such as split heat, delayed puberty, silent estrus, or hypoluteidism.
For in vitro diagnostic use only. For professional use only
TEST PRINCIPLE
- This test employs a quantitative competitive fluorescence immunoassay technique.
- The fluorescent signal intensity reflects the amount of cProgesterone captured. The concentration is expressed as ng/ml or nmol/L.
MATERIAL
コンテンツ | Quantity |
---|---|
Individual Sealed Pouches | 10 |
– Test Device | Per pouch |
– Desiccant Pouch | Per pouch |
ID Chip | 1 |
使用説明書 | 1 |
cProgesterone Sample Buffer Tubes | 10 |
Pipette Tips | 10 |
Material Required But Not Provided:
装置 |
---|
Immunofluorescence Analyzer |
Timer |
ピペット |
遠心 |
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 分.
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 時間 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 時間 after blood collection, store the specimen at 2 ~ 8℃ for no longer than 72 時間. 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 before 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.
- ピペット 50 メートル私 of prepared sample into the cProgesterone Sample Buffer and gently mix well. Vigorous agitation and foaming should be avoided.
- ピペット 100 メートル私 of mixed sample to add into the sample well (S) of the test device. Avoid forming bubbles.
- Test mode: a or b
ある) 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”, and start the timer right after adding the sample mixture to the sample well. Leave the Test Device at room temperature (18 ~ 28℃) のために 10 分. Then 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 cProgesterone 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 cProgesterone in canine serum or plasma.
- Detection range: 1.0 ~ 50ng/ml
- Conversion factor: 1ng/ml = 3.18nmol/L
- Reference range:
Item Result (ng/ml) | 結果 (nmol/L) | レベル | Suggestion |
---|---|---|---|
≤ 1.0 | ≤ 3.18 | Negative | Non-estrus phase |
1.0 – 5.0 | 3.18 – 15.9 | Low | Preovulation phase |
5.0 – 10.0 | 15.9 – 31.8 | Medium+ | Oviposit phase |
10.0 – 20.0 | 31.8 – 63.6 | Medium++ | The best potential fertility phase |
> 20.0 | > 63.6 | High+++ | Ootid senescence phase |
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 if the pouch is broken, torn, or not well sealed, or 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 the test and cause erroneous results.
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