CMV IgM Elecsys | REF 4784618190

The Roche Elecsys CMV IgM assay (REF 4784618190) is an electrochemiluminescence immunoassay (ECLIA) intended for the qualitative in vitro determination of IgM-class antibodies against cytomegalovirus (CMV) in human serum and plasma. The reagent kit is designed to run on Roche cobas e family immunoassay analyzers, supporting laboratories in serological workup of suspected primary or recent CMV infection.

Key Features
- Methodology: Electrochemiluminescence immunoassay (ECLIA) using the µ-capture principle with biotinylated and ruthenium-labeled recombinant CMV antigens.
- Result type: Qualitative, with reactive / non-reactive interpretation based on a cutoff index (COI).
- Sample types: Human serum and Li-, K2- and K3-EDTA, and lithium-/sodium-heparin plasma as specified in the official method sheet.
- Ready-to-use reagent rackpack with barcoded cassette for automated handling on cobas e analyzers.
- Onboard automation: integrated calibration and quality control workflow within the cobas e platform.
- Total assay time: Refer to the current Roche method sheet for exact incubation and result times.

Clinical Applications
- Aid in the serological assessment of suspected acute or recent primary CMV infection.
- Supports laboratory workup in prenatal screening programs where CMV serostatus is requested by the clinician.
- Useful in the evaluation of immunocompromised patients, including transplant and oncology populations, as part of a broader CMV diagnostic panel (typically alongside CMV IgG and avidity testing).
- Investigation of mononucleosis-like syndromes when EBV serology is non-reactive.

Product Information
- Brand: Roche
- Product: Elecsys CMV IgM
- REF / UPN: 4784618190
- Category: Roche Reagents – Immunoassay / Infectious Disease Serology
- Platform compatibility: Roche cobas e immunoassay analyzers (refer to current Roche compatibility matrix for specific module support)
- Test principle: ECLIA, IgM µ-capture format
- Pack size / number of tests: Not specified in the located sources
- Storage and shelf life: Not specified in the located sources – refer to the official Roche method sheet and product label.
- Regulatory status: Refer to the country-specific Roche labeling for in vitro diagnostic registration and intended use statements.

REF / UPN4784618190
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