RIAKEY CA15-3 IRMA Tube II

INTENDED USE : Immunoradiometric assay for quantitative determination of cancer antigen 15-3(CA15-3) in human serum or plasma

PINTRODUCTION

The MUC-1 antigen is a membrane-anchored mucin-type glycoprotein present in malignant and epithelial cells of certain organs, e.g. breast, lung, ovary and pancreas. The apo-protein of the MUC-1 mucin contains a transmembrane domain, a cytoplasmic domain, and an extracellular carbohydrate rich domain. The extracellular domain is characterized by polymorphism with respect to the member of a 20 amino acid tandem repeat (VNTR polymorphism). The MUC-1 breast cancer mucin (CA15-3 antigen) is secreted from tumor cells and can be used as a serological marker of breast cancer.

PRINCIPLE OF THE ASSAY

The assay is a one-step non-competitive immunoradiometric assay (IRMA) method (sandwich principle). The present method employs several monoclonal anti-CA15-3 antibodies which recognize two different epitopes of the molecules. One antibody is absorbed in solid phase (coated tube), the others (labeled with Iodine-125, labeled with biotin) are used as tracer and tracer buffer. The sample to be tested, is incubated in the coated tube, following the incubation, after aspiration and washing, the labeled antibody is added to the coated tubes, where it binds to the solid phase, by means of the antigen in standards and samples. The amount of bound tracer will thus be directly proportional to the antigen concentration. After a further aspiration and washing cycle, the residual radioactivity in the tubes is measured in a gamma 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.