The Calbiotech CEA ELISA Kit is intended for the quantitative measurement of CEA in human serum.

SUMMARY AND EXPLANATION OF THE CEA TEST

Carcinoembryonic antigen (CEA), a 180 kD intercellular adhesion molecule expressed in high concentrations in the fetus but normally not found in adult serum because the synthesis of this protein ceases after birth. However reappear in a high concentration in the sera of patients with colorectal (57%), gastric (41%), hepatocellular (45%), pancreatic (59%) and biliary (59%) carcinoma. Thus the significance of measuring for CEA using a CEA blood test.  The serum concentration of CEA can also be elevated in benign diseases of the colorectum (inflammatory bowel disease 17%), stomach (chronic gastritis and peptic ulcer 14%), liver (cirrhosis and hepatitis 17%) and pancreas (21%). Elevated levels of CEA have also been observed in patients with inflammatory nonmalignant diseases like pulmonary emphysema, alcoholic cirrhosis, pancreatitis and in heavy smokers. In contrast to cancer these elevations are transitory. The serum levels drop back into the normal range within a few weeks. The primary use of the CEA test is to monitor patients after surgery for recurrent colorectal carcinoma. Serum CEA has sensitivity between 60% and 95% in detecting recurrences prior to clinical detection and a lead-time between 2 and 10 months (positive predictive value 65%; negative predictive value 70%). False- positive results are usually below 10.0 ng/ml.

PRINCIPLE OF THE CEA TEST

The CEA Blood Test is a solid phase direct sandwich ELISA method. The samples and diluted anti-CEA-HRP conjugate are added to the wells coated with Mab to CEA beta subunit. CEA in the patient’s serum binds to anti-CEA MAb on the well and the anti-CEA-HRP second antibody then binds to CEA. Unbound protein and HRP conjugate are washed off by wash buffer. Upon the addition of the substrate, the intensity of color is proportional to the concentration of CEA in the samples. A standard curve is prepared relating color intensity to the concentration of the CEA garnered using the CEA Blood Test.