Carcinoembryonic Antigen (CEA, CD66e) BioAssay(TM) ELISA Kit

Carcinoembryonic antigen (CEA) is a cell-surface 200-kd glycoprotein. In 1969, it was reported that plasma CEA was elevated in 35 of 36 patients with adenocarcinoma of the colon and that CEA titers decreased after successful surgery. Normal levels were observed in all patients with other forms of cancer or benign diseases. Subsequent studies have not confirmed these initial findings, and it is now understood that elevated levels of CEA are found in many cancers. Increased levels of CEA are observed in more than 30% of patients with cancer of the lung, liver, pancreas, breast, colon, head or neck, bladder, cervix, and prostate. Elevated plasma levels are related to the stage and extent of the disease, the degree of differentiation of the tumor, and the site of metastasis. CEA is also found in normal tissue. Intended Use: The CEA enzyme immunoassay test kit is intended for the quantitative determination of CEA concentration in human serum. Principle of the Test: The CEA Quantitative Test Kit is based on a solid phase enzyme-linked immunosorbent assay. The assay system utilizes one monoclonal anti-CEA antibody for solid phase (microtiter wells) immobilization and another mouse monoclonal anti-CEA antibody in the antibody-enzyme (horseradish peroxidase) conjugate solution. The standards and test specimen (serum) are added to the CEA antibody coated microtiter wells. Then CEA antibody labeled with horseradish peroxidase (conjugate) is added. If human CEA is present in the specimen, it will combine with the antibody on the well and the enzyme conjugate resulting in the CEA molecules being sandwiched between the solid phase and enzyme-linked antibodies. After 1 hour incubation at room temperature, 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 CEA is directly proportional to the color intensity of the test sample. Detection Range: 0-120ng/ml Specificity: 98.7% Sensitivity: 1.0ng/ml Kit Components: Microtiter Plate, 1x96wells CEA Standard 0ng/ml, 2x500ul CEA Standard 3ng/ml, 2x500ul CEA Standard 12ng/ml, 2x500ul CEA Standard 30ng/ml, 2x500ul CEA Standard 60ng/ml, 2x500ul CEA Standard 120ng/ml, 2x500ul Enzyme Conjugate Reagent, 1x12 ml Substrate TMB, 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.