IVD Reagents

Please pay attention to the revision of the document that must be the same as the revision reported in the box label.
In case of discrepancy please contact our Customer Care e-mail: info@adaltis.net.

* Other document related to the product available at Documentation Centre and it is accessible for Adaltis distributors/partners after registration only.

The Eclectica BR Marker CA 15-3 assay for the Eclectica analyzers shas been designed for the quantitative determination of breast cancer associated antigen MUC-1 (CA 15-3) in human serum and heparinized plasma. The method is used with on line dilution for samples up to 750 U/ml (U = arbitrary units: there is no internationally recognized standard for the measurement of CA 15-3).

The MUC-1 protein is the apoprotein of several membrane-bound and secreted mucin-type glycoproteins produced by normal and malignant cells of human epithelia, including those of the breast, lung, ovary and pancreas. (1,2).

The MUC-1 mucin (CA 15-3 antigen) is secreted from tumor cells, and its serological determination (of MUC-1) can be used as a marker of breast cancer.

The MUC-1 mucin is a unique mucin as the protein core contains a transmembrane domain, a cytoplasmic domain, and an extra-cellular carbohydrate rich domain.

The MUC-1 characteristic portion of the extra-cellular domain is a 20 amino acid sequence, which is repeated ~20 -- ~80 times between different   individuals. The polymorphism with respect to the number of the 20 ammino acid tandem repeat (VNTR polymorphism) and the variation in glycosylation between individuals, different organs and between normal and malignant cells could explain the heterogeneity of the MUC-1 mucin. (3).

The assay uses two MAbs, directed to epitopes located on the 20 amino acid   tandem repeat sequence.

The Ma 695 Mab is directed to a carbohydrate epitope of the MUC-1 glycoprotein.

The Ma 552 Mab is directed to a hexapeptide (TRPAPG) in the tandem repeat region of the MUC-1 core protein. (4,5).

The Eclectica BR Marker CA 15-3 assays for the Eclectica analyzers consists of:

1. Eclectica BR Marker CA 15-3 Reagent kit: specific reagents of Eclectica BR Marker CA 15-3 kit to execute the test and to verify the standardization.
2. Eclectica BR Marker CA 15-3 Calibration Kit: for standardization.
3. Eclectica Diluent 2 Kit: for samples dilution.
4. Eclectica Immunoassay Common Reagents Kit: for general chemistry reaction.
5. Eclectica Immunoassay Wash Solution: Wash Solution specific for Immunological reaction.
6. Eclectica Systemic Wash Solution: Wash Solution of Eclectica system.

In the Eclectica BR Marker CA 15-3 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-CA 15-3 monoclonal antibody and anti-CA 15-3 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-CA 15-3 monoclonal antibody binds to a discrete site on the CA 15-3 antigen molecule. Alkaline phosphatase anti-CA 15-3 monoclonal antibody binds to a second site on the CA 15-3 antigen 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 CA 15-3 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 CA 15-3 antigen in the sample. The concentration of CA 15-3 antigen in a patient sample or control is then determined by interpolation from a stored standard curve.

Eclectica BR Marker CA 15-3 Reagent Kit

Eclectica BR Marker CA 15-3 Calibration Kit

Eclectica Diluent 2 Kit

Eclectica Immunoassay Common Reagents Kit

Eclectica Immunoassay Wash Solution

Eclectica Systemic Wash Solution

1700006 Eclectica Cleaning Kit