4096 – RF Latex

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 of rheumatoid arthritis in conjunction with other clinical and laboratory findings. The immunoassay is designed for manual professional in vitro diagnostic use.

Diagnostic Relevance

The measurement of rheumatoid factor (RF), an antibody directed against the Fc-region of IgG, is used in the diagnosis of rheumatoid arthritis (RA). These antibodies, RF, are present in the sera of 70 – 80 % rheumatoid arthritis (RA) patients and have been identified as part of the criteria for the classification of RA by the American College of Rheumatology. The presence of RF, which can occur years prior to the onset of diseases, demonstrates a 5 – 40 times higher risk of RA. High concentrations of RF are often associated with a more severe disease comprising a faster destruction of joints. In addition, they are found in patients with extra-articular manifestations such as rheumatoid nodules, polyneuropathy, vasculitis or Sicca syndrome.

Product Specifications

Title RF Latex
Product code 4096
Indication Rheumatoid arthritis
Description Latex agglutination test for the qualitative and semi-quantitative detection of rheumatoid factor (RF) in human serum
Format Agglutination slide and latex beads coated with human IgG
Incubation time 2 min.
Sample volume 40 µL serum
No. of determinations 100 (100 x 1)

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Current version of the instructions for use. The respective valid version for processing the test can be found in the product packaging.