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Carbohydrate Antigen 125(CA125)Rapid Quantitative Test(Fluorescence immunoassay)
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.
The CA125 Rapid Test is a one-step chromatographic sandwich immunoassay designed for the quantitative measurement of CA125. The CA125 antigen in the sample was first bound with the conjugated compound of fluorescent labeled CA125 monoclonal antibody, then moved and combined with another CA125 monoclonal antibody fixed on the nitrocellulose membrane, and the double antibody sandwich complex was formed at the detection line of the cellulose nitrate membrane. The quantitative detection results were obtained by NIR-1000 dry fluoroimmunoassay analyser.
|Test cards||25||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(300μL/tube)||Phosphate buffer|
|ID card||1||With specific stand curve file|
The components in different batches of kits cannot be used interchangeably.
【Storage conditions and validity】
The kit should be stored at 4℃~30℃, out of direct sunlight. It is valid for 18 months. The test card should be used within 15 minutes after unsealing under the environment of 15℃~30℃ and 20% ~ 90% relative humidity.
The production date, batch number and expiration date are shown in the outer package of the product.
NIR-1000 dry fluoroimmunoassay analyser produced by WWHS Biotech. Inc.
Normal healthy adult women who did not suffering from ovarian cancer, 95% had CA125 values less than 35U/mL. It is recommended that each laboratory should establish its own normal range based on a representative sampling of the local population.
【Interpretation of results】
【Limitations of methods】
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.
1. This kit is only used for in vitro diagnosis.
2. The test card and sample diluent are disposable and cannot be reused.
3. Please check the integrity and validity of the kit package before use, and then open the package. When it is stored at low temperature, it should be restored to room temperature (15℃ ~ 30℃) before opening the package for use. The reagents with damaged inner package and beyond the validity period cannot be used.
4. The requirements of specimen collection and storage should be strictly observed. If the specimen is turbid, it should be centrifuged and discarded before use.
5. The used kits should be treated as potential infectious substances, and all samples, reagents and potential pollutants should be disinfected and treated according to the relevant local regulations.
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