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.
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.