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Elecsys CYFRE 21-1: Immunoassay for the in vitro quantitative determination of tragments of cytokeratin 19 in human serum and plasma (Li-Heparin. K2-EDTA and K3-EDTA). The assay is to be used as an aid in monitoring disease progression during the course of disease and treatment in lung cancer patients. Serial testing for patient CYFRA 21-1 assay values should be used in conjunction with other clinical methods used for monitoring lung cancer. The electrochemiluminescence immunoassay "ECLIA" is intended for use on Elecsys and cobas e immunoassay analyzers. Elecsys CYFRA 21-1 CalSet: CYFRA 21-1 is used for calibrating the quantitative Elecsys CYFRA 21-1 assay on the Elecsys and cobas e immunoassay analyzers. Elecsys PreciControl Tumor Marker: PreciControl Tumor Marker is used for quality control of Elecsys immunoassays on Elecsys and cobas e immunoassay analyzers.

(1) The Elecsys CYFRA 21-1 Immunoassay is a two-step sandwich immunoassay with streptavidin microparticles, a biotinylated monoclonal cytokeratin 19-specific antibody, and a monoclonal cytokeratin 19-specific antibody labeled with a ruthenium complex and electrochemiluminescence detection. Results are determined using a calibration curve that is generated specifically on each instrument by a 2 point calibration master curve (5-pointcalibration) provided with the reagent bar code. (2) The Elecsys CYFRA 21-1 CalSet is a lyophilized product consisting of Cytokeratin from cell culture of the cell line MCF-7 in two concentration ranges (approximately 0 ng/mL and 50 ng/mL) in a cytokeratin free human serum matrix with preservative. During manufacture, the analyte is spiked ito the matrix at the desired concentration levels. (3) The Elecsys PreciControl Tumor Marker (CYFRA 21-1) is a lyophilized control serum in two concentration ranges (approximately 3.29 ng/mL and 27.2 ng/mL). Note: The reagent, calibrator, and the quality control materials are all packaged separately.

The CYFRA 21-1 EIA kit is intended for the quantitative determination of soluble cytokeratin 19 fragments in human serum. The assay is to be used as an aid in monitoring disease progression during the course of disease and treatment in lung cancer patients. Serial testing for patient CYFRA 21-1 assay values should be used in conjunction with other clinical methods used for monitoring lung cancer.

The CYFRA 21-1 EIA is a solid phase, non-competitive immunoassay based on two monoclonal antibodies (derived from mice) directed against two separate antigenic determinants of soluble fragments of cytokeratin 19. Calibrators, controls and patient samples are incubated together with biotinylated Anti-CYFRA 21-1 MAb and horseradish peroxidase (HRP) labeled Anti-CYFRA 21-1 MAb in streptavidin coated micro strips. After washing, buffered Substrate/Chromogen reagent (hydrogen peroxide and 3, 3', 5, 5' tetramethylbenzidine) is added to each well and the enzyme reaction is allowed to proceed. During the enzyme reaction a blue color will develop if antigen is present. The intensity of the color development is proportional to the amount of CYFRA 21-1 present in the samples. The color intensity is determined in a microplate spectrophotometer at 620 nm (or optionally at 405 nm after addition of Stop Solution). Calibration curves are constructed for each assay by plotting absorbance value versus the concentration for each calibrator. The CYFRA 21-1 concentrations of patient samples are then read from the calibration curve.