Place of Origin:
CN
Brand Name:
WWHS
Certification:
CE
Model Number:
CA125
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Carbohydrate Antigen 125(CA125)Rapid Quantitative Test(Fluorescence immunoassay)
Ⅰ.Components of a product
| Name | Quantity | Component |
| Test cards | 25/40 | It is composed of fluorescent pad (coated with fluorescent labeled CA125 monoclonal mouse antibody), nitrocellulose membrane (coated with CA125 monoclonal mouse antibody and Goat anti mouse IgG antibody), absorbent paper and backing |
| Sample diluent | 25/40 | Phosphate buffer |
| ID card | 1 | With specific stand curve file |
The components in different batches of kits cannot be used interchangeably.
Ⅱ.Intended use
This kit is used for quantitative determination of CA125 in human whole blood, plasma and serum.
CA125 is a high molecular weight mucin type glycoprotein, originally defined by the CA12-5monoclonal antibody (MAb) established by Bast et al. CA125 is a protein that is a so-called tumor marker or biomarker, which is a substance that is found in greater concentration in tumor cells than in other cells of the body. In particular, CA125 is present in greater concentration in ovarian cancer cells than in other cells. It was first identified in the early 1980s, and the function of the CA125 protein is not currently understood..
CA 125 is usually measured from a blood sample. It can also be measured in fluid from the chest or abdominal cavity. The tests currently in use are all based upon the use of an antibody that is directed against the CA 125 protein (monoclonal antibody technique).
CA125 has proved especially valuable to oncologists in both detection of ovarian cancer and disease monitoring of ovarian cancer patients.
Ⅲ.Procedure of a product
1. Before the test, please read the instructions completely. If the test card and sample are stored in cold storage, they should be balanced at room temperature (15-30)℃ for not less than 30min before use.
2. Start NIR-1000 dry fluoroimmunoassay analyser according to the instruction manual of the instrument, and carry out quality control verification according to the instruction manual of the instrument(Note: the reagent has been calibrated in advance, and the calibration curve parameters of each batch of reagent have been stored in the information card. The information card is inserted before use, so it is not necessary to calibrate again, and the test can be carried out only after the quality control is passed. Otherwise, the cause should be found out before testing.)
3. Remove the test card from the aluminum foil bag and use it within 15 minutes.
4. Place the test card on a clean horizontal table and mark it horizontally.
5. Mix 100 µL of patient sample with 300µL of sample diluent. Apply 100 µL of diluted samples to the well of the test card.
6. Insert the test card into NIR-1000 dry fluoroimmunoassay analyser, read and record the results at 10 minutes after addition of samples, then dispose of used test appropriately.
Ⅳ.Why to choose us?
1. Limits of detection
No more than 20U/mL.
2. Accuracy
The relative deviation from the target value is within ±15%.
3. Precision
The within and between assay coefficient of variations are within 15%.
4.Linear range
Within the linear range (20-500U/mL), the linear correlation coefficient R≥0.990.
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