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Demeditec:: Cyfra 21-1 RIA (Coated Beads)

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Tumor Diagnostic
Cat.-No.: DE3937

Product: Cyfra 21-1 RIA (Coated Beads)

TEST SPECIFICATIONS

Cyfra 21-1 RIA (Coated Beads)

Technology

: RIA/CB

Kit size

: 100 determinations

Sample material

: serum

Sample preparation

: -

Sample volume

: 100 µl

Standard range

: 2.9 - 52.0 ng/ml

Incubation

: 20 h (2-8°C)

Measuring system

: I-125 <59,4 kBq

Sensitivity

: -


Special remarks:

1         Name and Intended Use

The DEMEDITEC CYFRA 21-1 RIA is an in vitro blood test for the quantitative measurement of cytokeratin 19 fragments in serum.

CYFRA 21-1 assay results are currently being evaluated in lung cancers and other malignant and benign diseases.

2         Principle of the Test

The DEMEDITEC CYFRA 21-1 RIA is a solid phase radioimmunoassay based on the “simultaneous sandwich“ principle.

Polystyrene beads coated with KS19.1, a mouse monoclonal antibody, are incubated with specimens, standards or controls, and tracer. The tracer is composed of 125I‑labeled BM19.21 a mouse monoclonal antibody. During this incubation, the antigen present in the specimen forms sandwich complexes with monoclonal antibodies. Unbound materials are removed by washing the beads. The bound radioactivity, measured by a gamma counter, is proportional to the concentration of the antigen in the specimen within the working range of the assay.

A standard curve is obtained by plotting the concentration of the standards vs. the bound counts-per-minute (CPM) values obtained for the standards. The CYFRA 21-1 assay results of the specimens and controls can be determined by converting the obtained CPM values to nanograms per mL (ng/mL) values using the standard curve obtained in the same assay.