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|Method & Line||Sample & Target||Product||Package Info|
|IMMUNOgen - Immunoassays||Plasma,Serum||HCG||Tests per Package: 100|
|IMMUNOgen||The Eclectica hCG assay for the Eclectica and Eclectica TiCA analysers has been designed for the quantitative determination of human chorionic gonadotrophin (hCG) in human serum and heparinized plasma. The method can be used without dilution for samples containing 1.0 to 500 mIU/ml of hCG. Primary calibration is against the WHO 1st International Reference Preparation IRP (75/537) for human chorionic gonadotrophin.||Code: 1703000||Package: 2 x 50|
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The Eclectica hCG assay for the Eclectica analyzers has been designed for the quantitative determination of human chorionic gonadotrophin (hCG) in human serum and heparinized plasma. The method can be used without dilution for samples containing 1.0 to 500 mIU/ml of hCG. Primary calibration is against the WHO 1st International Reference Preparation IRP (75/537) for human chorionic gonadotrophin (1).
Human chorionic gonadotrophin is a sialoglycoprotein of molecular weight about 40,000. It is composed of two subunits of unequal size, alpha and beta. The alpha subunit is virtually identical to that of pituitary luteinizing, follicle stimulating and thyroid stimulating hormones (LH, FSH, TSH). Biological specificity is conferred on these hormones by the differences in their beta subunits, which also allow them to be distinguished immunologically (2). The beta subunit of hCG is similar to that of LH; it has extra amino acid residues at the C-terminal end and is more heavily glycosylated. While the glycosylation has little or no effect on the action or immunological properties of hCG, it does affect its metabolism; removal of the sugar residues greatly reduces its biological half-life (3).
The physiological action of hCG reflects its structural similarity to LH. It is produced in large amounts by the placental syncytiotrophoblast, and in early pregnancy acts to sustain the corpus luteum beyond its normal lifetime (4). In this way, estrogen and progesterone production, necessary for the maintenance of the endothelium, is continued, allowing pregnancy to proceed. Later in pregnancy, the placenta develops the capability to produce adequate amounts of steroid hormones itself, and hCG production is reduced. It has also been proposed that placental production and secretion of hCG protects it from attack by the maternal immune system (5). Another action reminiscent of LH is the stimulation of testosterone production by the testes of male fetuses, necessary for normal masculinization. hCG can also be produced in relatively large quantities by a variety of tumors, especially those of trophoblastic origin, such as choriocarcinoma and teratoma (6).
The main clinical usefulness of measuring hCG is in testing for pregnancy. Since the first scientifically described pregnancy test (7), the sensitivity of hCG assays has increased, and pregnancy can now be detected even before the first missed menstrual period (8). However, recent research (9) has shown that "pregnancy" may be detected by sensitive hCG assays in the absence of any other signs of conception. This is often termed a "chemical pregnancy" and its occurrence suggests that pregnancy should not be confidently diagnosed until a menstrual period has been missed. hCG measurements may also be used to aid in the differential diagnosis of ectopic pregnancy (10). hCG assays will not reliably distinguish between a normal and an ectopic pregnancy, but may serve to alert the physician to the possibility of ectopic pregnancy in a patient with abdominal pain.
The Eclectica hCG assays for the Eclectica analyzers consists of:
In the Eclectica hCG assay, three 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-hCG ß-subunit monoclonal antibody and two anti-hCG monoclonal Fab antibodies conjugated to alkaline phosphatase, are added to a sample, control, or standard. The reactants are incubated at 37°C. During the incubation fluorescein-anti-hCG ß-subunit monoclonal antibody binds to a discrete site on the ß-subunit. Alkaline-phosphatase anti-hCG monoclonal Fab antibodies bind to the intact hCG molecule or its hCG ß-subunit Fab 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 hCG or hCGß monoclonal antibody complexes 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 hCG in the sample. The concentration of hCG in a patient sample or control is then determined by interpolation from a stored standard curve.
Eclectica hCG Reagent Kit
Eclectica hCG Calibration Kit
Eclectica Diluent 1 Kit
Eclectica Immunoassay Common Reagents Kit
Eclectica Immunoassay Wash Solution
Eclectica Systemic Wash Solution
1700006 Eclectica Cleaning Kit