KFDA Registration No : | 14-3146 |
CAT No : | RC06N |
TEST METHOD : | IRMA |
SAMPLE VOLUME : | 25 ul |
INCUBATION TIME : | 120'RT |
STD RANGE : | 0-20 ng/ml |
INTENDED USE : Immunoradiometric assay for quantitative determination of free prostate specific antigen (FPSA) in human serum
The prostate is a male sex gland. It produces a thick fluid that forms part of the semen. The prostate is about the size of a walnut. It is located below the bladder and in front of the rectum. The prostate surrounds the upper part of the urethra, the tube that empties urine from the bladder. The prostate needs male hormones to function. The main male hormone is testosterone, which is made mainly by the testicles. Some male hormones are produced in small amounts by the adrenal glands.
The RIAKEY FPSA IRMA Tube II is an one step non-competitive immunoradiometric (IRMA) method (“sandwich”). The method employs two highly specific monoclonal anti-FPSA antibodies which recognize two different epitopes of the molecule. One antibody is coated on solid phase (coated tube), the other, specific for the FPSA 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 FPSA 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 FPSA antigen concentration and the remaining radioactivity bound to the tubes is measured in a gamma scintillation counter.