The CA-125 Quantitative Test Kit is based on a solid phase enzyme-linked immunosorbent assay. The assay system utilizes one monoclonal anti-CA-125 antibody for solid phase (microtiter wells) immobilization and another monoclonal anti-CA 125 antibody in the antibody-enzyme (horseradish peroxidase) conjugate solution. The standards and test specimen (serum) are added to the CA-125 antibody coated microtiter wells. Then CA-125 antibody labeled with horseradish peroxidase (conjugate) is added. If human CA-125 is present in the specimen, it will combine with the antibody on the well and the enzyme conjugate resulting in the CA-125 molecules being sandwiched between the solid phase and enzyme-linked antibodies. After a 3 hour incubation at 37 degrees C, the wells are washed with water to remove unbound labeled antibodies. A solution of TMB is added and incubated for 20 minutes, resulting in the development of a blue color. The color development is stopped with the addition of 2N HCl. The color is changed to yellow and measured spectrophotometrically at 450 nm. The concentration of CA-125 is directly proportional to the color intensity of the test sample.
Intended Use:
CA-125 EIA test is primarily intended for use as a monitoring and screening test. An abnormal result (i.e., elevated serum CA-125 level) can indicate ovarian cancer and suggests the need for further clinical management. The serum CA-125 test appears to be a useful tumor marker for patients in clinical remission, following treatment. Post-operative serum CA-125 values that fail to return to normal, strongly suggest the presence of residual tumor. Tumor recurrence is often accompanied by a rise of serum CA-125 before progressive disease is clinically evident.
Detection Range: 0-400U/ml
Specificity: 97%
Sensitivity: 5units/ml
Kit Components:
Microtiter Plate, 1x96wells
Enzyme Conjugate Reagent, 1x12ml
Standard 0units/ml, 1x1vial
Standard 15units/ml, 15units/ml, 1x1vial
Standard 15units/ml, 50units/ml, 1x1vial
Standard 15units/ml, 100units/ml, 1x1vial
Standard 15units/ml, 200units/ml, 1x1vial
Standard 15units/ml, 400units/ml, 1x1vial
TMB Substrate, 1x12ml
Stop Solution, 1x12ml
Wash Buffer Concentrate (50X), 1x15ml
Storage and Stability:
Store all components at 4 degrees C. Stable for 6 months. For maximum recovery of product, centrifuge the original vial prior to removing the cap.