For Business Use Only. Does Not Ship to Residential Addresses. For use inside an Analyzer, Sold Separately.
Specifications
Manufacturer: Beckman Coulter
Country of Origin: Japan
Application: Reagent
Number of Tests: 4 X 250 Tests
Test Method: Latex-enhanced Immunoturbidimetric Method
Test Name: Rheumatoid Factor
Test Type: Autoimmune Assay
UNSPSC Code: 41116004
Intended Use
System reagent for the quantitative determination of Rheumatoid Factor (RF) in human serum and plasma on Beckman Coulter AU analyzers.
For in vitro diagnostic use only.
R1: Colorless to slightly yellow; Clear; Liquid; Odorless
R2: White; Clear; Liquid; Odorless
About RF (Rheumatoid Factor) Reagent
Rheumatoid factors (RF) are antibodies directed against antigenic determinants on the Fc fragment of IgG. These are usually IgM antibodies, but may be IgG, IgA or IgE. Rheumatoid factor sensitivity in rheumatoid arthritis varies from 30% in population-based studies to 70 – 80% in hospital-based studies, where the disease tends to be more severe. Higher titres of RF are more specific for the diagnosis of rheumatoid arthritis (RA) and are more common in patients with rapidly progressive joint destruction and in those with extraarticular manifestations such as subcutaneous rheumatic nodules. However, RF is a non-specific test and a positive RF is observed in 1 – 5% of the healthy population at low titres and in 15 – 20% of elderly subjects with other chronic disease states. Similarly a negative result does not exclude RA. Approximately 25% of patients with a diagnosed case of RA may present with a negative result for RF. A positive RF is also seen in autoimmune rheumatic diseases and in non-rheumatic conditions with variable frequency e.g. SLE, Sjögren’s syndrome, subacute bacterial endocarditis and other bacterial infections, infectious hepatitis, chronic liver diseases, chronic active pulmonary diseases, parasitic infections and viral infections.
Methodology
Immune complexes formed in solution scatter light in proportion to their size, shape and concentration. Turbidimeters measure the reduction of incidence light due to reflection, absorption or scatter. In this procedure, the decrease in light intensity transmitted (increase in absorbance) through particles suspended in solution is as a result of complexes formed during the immunological reaction between the RF of the patient serum and the anti-RF IgG antibodies coated on the latex particles.
Additional Information
RF (Rheumatoid Factor) Reagent - Safety Data Sheet
RF (Rheumatoid Factor) Reagent - Instructions for Use
