CA 15-3 G2 Elecsys | REF 3045838122

The Roche CA 15-3 G2 Elecsys reagent (REF 3045838122) is an electrochemiluminescence immunoassay (ECLIA) intended for the in vitro quantitative determination of the CA 15-3 antigen (mucin-1, MUC-1) in human serum and plasma. The assay is designed for use on Roche cobas e immunoassay analyzers and forms part of the Elecsys tumor marker menu used by clinical laboratories for serial monitoring workflows.

Key Features
- Electrochemiluminescence immunoassay (ECLIA) technology on the Elecsys platform.
- Sandwich principle using biotinylated and ruthenium-labeled monoclonal antibodies directed against the CA 15-3 (MUC-1) epitope.
- Standardized against the previous Elecsys CA 15-3 assay to support continuity of patient results.
- Ready-to-use, barcoded reagent cassette for automated loading and identification.
- Compatible with human serum and plasma sample types as defined in the official method sheet.
- Total assay duration and onboard stability as specified in the current Roche method sheet.

Clinical Applications
- Quantitative measurement of CA 15-3 (MUC-1) tumor-associated antigen in serum and plasma.
- Intended to support laboratory workflows for serial monitoring of CA 15-3 levels as defined by the manufacturer's instructions for use.
- For professional in vitro diagnostic use in clinical chemistry and immunoassay laboratories operating Roche cobas e analyzers.
- Specific clinical indications, intended population and interpretation must follow the official Roche IFU and applicable local regulatory labeling.

Product Information
- Product: CA 15-3 G2 Elecsys
- Brand: Roche
- Category: Roche Reagents
- REF/UPN: 3045838122
- Assay technology: Electrochemiluminescence immunoassay (ECLIA)
- Analyte: CA 15-3 (MUC-1)
- Sample types: Human serum and plasma as listed in the Roche method sheet
- Platform compatibility: Roche cobas e immunoassay analyzers as listed in the current Roche method sheet
- Number of tests per kit: Not specified in the located sources
- Measuring range: Not specified in the located sources
- Storage and stability: Not specified in the located sources
- Regulatory status: Refer to the official Roche labeling and local regulatory registration for the destination market.

REF / UPN3045838122
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