RIAKEY CA125 IRMA Tube II

INTENDED USE : Immunoradiometric assay for quantitative determination of cancer antigen 125 (CA125) in human serum or plasma

PINTRODUCTION

In 1981, Bast et al, first obtained monoclonal antibody CA125, which was produced using lymphocytes from a mouse immunized with OVCA 433, a cell line derived from a papillary serous cystadenocarcinoma of the ovary. The CA125 reactive determinants, isolated from either cell culture or serum, are found on a heterogeneous, high molecular weight (200 to 1,000 kilodalton) glycoprotein (designated CA125 antigen). The determinant is proteinaceous in nature, but has nondeterminant associated carbohydrate moieties. CA125 reactive determinants are not present in the surface epithelium of either normal fetal or adult ovaries, with the exception of inclusion cysts, areas of meraplasia, and papillary excrescences. In fetal tissue, CA125 reactive determinants have been observed in the amnion and in derivatives of the coelomic epithelium. In women with primary epithelial ovarian carcinoma who had undergone first-line therapy and were candidates for diagnostic second-look procedures, a CA125 assay value greater than or equal to 35 U/mL was found to be indicative of the presence of residual tumor. Assuming the physician cannot identify alternative causes for an elevated CA125 assay value, a CA125 assay value determined to be greater than or equal to 35 U/mL provides substantial evidence that residual tumor is present.

PRINCIPLE OF THE ASSAY

The RIAKEY CA125 IRMA Tube II is an one step non-competitive immunoradiometric (IRMA) method (“sandwich”). The method employs two highly specific monoclonal anti-CA125 antibodies which recognize two different epitopes of the molecule. One antibody is coated on solid phase (coated tube), the other, specific for the CA125 and labeled with Iodine-125, is used as a tracer. Antibody-coated polystyrene tubes serve as solid phase. The tracer antibody and the coated antibody react simultaneously with the CA125 antigen present in the standards, control serum and samples. Unbounded material is removed by a washing step. The amount of bound tracer will be directly proportional to the CA125 antigen concentration and the remaining radioactivity bound to the tubes is measured in a gamma scintillation counter.

USE PRECAUTION

• Do not use mixed reagents from different lots.
• Do not use reagents beyond the expiration date.
• Use distilled water stored in clean container.
• Use an individual disposable tip for each sample and reagent, to prevent the possible cross-contamination among the samples.
• Store the unused coated tubes at 2~8ºC in the appropriate bags with silica gel and accurately sealed.
• If large quantity of assay would be performed at one time, there might be substantial time variation between 60 tubes at one time to minimize time variation. Also, do not exceed 10 minutes for entire pipetting.
• Wear disposable globes while handling the kit reagents and wash hands thoroughly afterwards.
• Do not pipette by mouth.
• Do not smoke, eat or drink in areas where specimens or kit reagents are handle.
• Handle samples, reagents and loboratory equipments used for assy with extreme care, as they may potentially contain infectious agents.
• When samples or reagents happen to be split, wash carefully with a 3% sodium hypochlorite solution.
• Dispose of this cleaning liquid and also such used washing cloth or tissue paper with care, as they may also contain infectious agents.
• Avoid microbial contamination when the reagent vial be eventually opend or the contents be handled.
• Use only for IN VITRO.