4096 – RF Latex

Highlights

• Use of human IgG-coated latex particles as solid-phase antigen
• Qualitative and semi-quantitative detection of rheumatoid factor (RF) in human serum
• Supports the diagnosis and monitoring of rheumatoid arthritis in combination with clinical and laboratory findings
• Agglutination-based assay provides rapid and reliable results
• Ready-to-use reagents (exception: optional buffers)
• High diagnostic relevance for early and progressive forms of rheumatoid arthritis
• Suitable for routine laboratory testing and screening
• Manual, professional in vitro diagnostic use
• CE marked

Intended Purpose

The RF Latex is a qualitative and semi-quantitative immunoassay for the determination of rheumatoid factor (RF) in human serum. The RF Latex is intended as an aid in the diagnosis and monitoring of rheumatoid arthritis (RA) in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

Rheumatoid factors (RF) are autoantibodies that target antigenic sites in the Fc fragment of human and animal IgG. They are frequently present in patients with rheumatoid arthritis and can appear years before clinical symptoms, making them a sensitive marker for early detection. Elevated RF levels are often linked to more severe disease and accelerated joint damage. Detection of RF via latex agglutination assays is based on the ability of patient sera to agglutinate latex particles coated with human IgG. This principle enables rapid, semi-quantitative assessment of RF levels and sees widespread use in routine diagnostics. Clinicians may also detect RF in other autoimmune disorders, chronic infections, or in older adults without clinical disease, highlighting the need to interpret results in the context of clinical and laboratory findings.