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The ADVIA Centaur Cytokeratin Fragment 21-1 (CYFRA) assay is for in vitro diagnostic use in the quantitative measurement of cytokeratin 19 fragments in human serum and plasma (EDTA and lithium heparin) using the ADVIA Centaur XPT system.

The measurement of cytokeratin 19 is 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 information used for monitoring lung cancer.

The ADVIA Centaur Cytokeratin Fragment 21-1 assay includes 1 ReadyPack primary reagent pack containing ADVIA Centaur CYFRA Lite Reagent and Solid Phase and ADVIA Centaur CYFRA master curve card.

The ReadyPack consists of the following:

ADVIA Centaur Cytokeratin Fragment 21-1 ReadyPack primary reagent pack; Liquid Lite Reagent 10.0 mL/reagent pack KS19.1 monoclonal antibody acridinium conjugate in buffer containing bovine serum albumin; surfactant; and preservatives.

ADVIA Centaur Cytokeratin Fragment 21-1 ReadyPack primary reagent pack; Liquid Solid Phase Reagent 17.5 mL/reagent pack BM19.21 monoclonal antibody coupled to magnetic microparticle bead in buffer containing bovine serum albumin; surfactant; and preservatives.

ADVIA Centaur Multi-Diluent13 ReadyPack ancillary reagent pack; 2×10.0mL/reagent pack; Buffer; surfactant; sodium azide (< 0.1%)

This assay is a fully automated 1-step sandwich immunoassay using acridinium ester chemiluminescent technology. The Solid Phase contains magnetic microparticles coated with anti-CYFRA 21-1 BM19.21 mouse monoclonal antibody. The Lite Reagent consists of acridinium ester-labeled anti-CYFRA 21-1 KS19.1 mouse monoclonal antibody. A direct relationship exists between the amount of CYFRA 21-1 present in the patient sample and the amount of relative light units (RLUs) detected by the system.

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