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|Method & Line||Sample & Target||Product||Package Info|
|IMMUNOgen - Immunoassays||Plasma,Serum||CEA||Tests per Package: 100|
|IMMUNOgen||The Eclectica CEA assay for the Eclectica and Eclectica TiCA analysers has been designed for the quantitative determination of Carcinoembryonic (CEA) in human serum and heparinized plasma. The method can be used without dilution for samples containing 15 to 2500 mIU/ml (1 – 167.5 ng/ml) of CEA. Primary calibration is against the WHO 1st International Reference Preparation (73/601) for CEA.||Code: 1706600||Package: 2 x 50|
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The Eclectica CEA assay for the Eclectica analyzers has been designed for the quantitative determination of Carcinoembryonic (CEA) in human serum and heparinized plasma. The method can be used without dilution for samples containing 15 to 2500 mIU/ml (1 – 167.5 ng/ml) of CEA. Primary calibration is against the WHO 1st International Reference Preparation (73/601) for CEA (1).
Carcinoembryonic antigen (CEA) was first described by Gold and Freedman in 1965 as a complex immunoreactive glycoprotein found in epithelial adenocarcinomas of the colon and fetal colon (2, 3). CEA has a molecular weight of approximately 180,000 daltons and represents a heterogenous group of a molecular species consisting of single polypeptide chains with varying carbohydrate components. The ratio of protein to carbohydrate varies from 1.1 to 1.5 in CEA molecules from different tumours (4, 5).
Originally CEA was thought to be only present in fetal intestine, pancreas and liver during the first two trimesters of gestation (3), but since the development of sensitive radioimmunoassay techniques, CEA has also been detected in a variety of non-neoplastic, non-fetal tissues and almost all extravascular body fluids (6, 7). Although the exact function of CEA is not known, it has been suggested that CEA may serve as a structural membrane protein or receptor (7). CEA is metabolised primarily by the liver and therefore hepatic diseases may impede clearance rates and increase serum concentrations of CEA (8, 9). Elevated serum levels of CEA may be found in a variety of benign and malignant conditions other than carcinoma of the colon. Conditions that may cause elevated levels of CEA include hepatic cirrhosis, hepatitis, heavy smoking, bronchitis, pancreatitis, gastritis, inflammatory bowel disease and renal disease (6, 10). In patients with no known carcinomas, increased levels of CEA have been detected in 13% of heavy smokers, 15-20% of patients with pancreatitis or polyps of the colon or rectum and 10-50% of patients with inflammatory intestinal disease. Approximately 50% of patients with severe hepatocellular disease or biliary obstruction have raised serum CEA levels (11, 12). However, these conditions are usually in an active state when associated with raised CEA levels (13).
Several epithelial carcinomas other than that of the colon produce CEA. These include carcinoma of the pancreas, lung, breast, stomach, thyroid gland and the female reproductive tract. Of these, levels of CEA are most commonly raised in carcinoma of the pancreas (65-90%) and lung (52-77%) (14, 15).
Gold and Freedman originally considered CEA to be a specific tumour-marker for the diagnosis of colorectal cancer (3), but more recent studies have not substantiated this (7). Its main use is in the monitoring of cancer patients after surgery, chemotherapy or radiotherapy (16). Successful removal of the tumour is usually followed by a decrease in the concentration of circulating CEA (17), whereas recurrence of the primary tumour or metastases is accompanied by increasing concentrations (18).
The Eclectica assays for the Eclectica analyzers consists of:
In the Eclectica CEA assay, two high affinity monoclonal antibodies are used in an immunoenzymetric assay system which incorporates magnetic solid phase separation. All incubation times and reagent volumes are determined by an assay specific software protocol.
Fixed amounts of fluorescein-conjugated anti-CEA monoclonal antibody and anti-CEA monoclonal antibody conjugated to alkaline phosphatase are added to a sample, control, or standard. The reactants are incubated at 37°C. During the incubation fluorescein-anti-CEA monoclonal antibody binds to a discrete site on the CEA molecule. Alkaline phosphatase anti-CEA monoclonal antibody binds to a second site on the CEA molecule forming a sandwich.
At the end of the incubation period anti-fluorescein coupled to a magnetic solid phase is added in excess. This rapidly and specifically binds to the CEA monoclonal antibody complex and is sedimented in a magnetic field.
After aspirating the liquid phase and washing the solid phase, a solution of the enzyme substrate, phenolphthalein monophosphate is added to the incubation cell and the each cell incubated at 37°C. After incubation the enzyme reaction is stopped by the addition of a stop reagent and the intensity of the color developed is measured photometrically. The intensity of the color developed is directly proportional, within the working range of the assay, to the concentration of CEA in the sample. The concentration of CEA in a patient sample or control is then determined by interpolation from a stored standard curve.
Eclectica CEA Reagent Kit
Eclectica CEA Calibration Kit
Eclectica Diluent 4 Kit
Eclectica Immunoassay Common Reagents Kit
Eclectica Immunoassay Wash Solution
Eclectica Systemic Wash Solution
1700006 Eclectica Cleaning Kit