Biosystems Rheumatoid Factor Reagent INTENDED USE
Reagents for the measurement of rheumatoid factors (RF) concentration in human serum. The
obtained values are useful as an aid in the diagnosis of rheumatoid arthritis.
This reagent is for use in the BioSystems BA analyzers or in other analyzer with similar
Rheumatoid Factors (RF) are a group of IgM antibodies (although IgG and IgA have been also
described) directed against the Fc fragment of the IgG molecules.
RF is mainly present in the serum of patients with rheumatoid arthritis but other diseases may
also produce .
RF: chronic inflammatory processes, infectious diseases such as subacute bacterial
endocarditis, malaria, syphilis, leprosy, leishmaniasis, tuberculosis and a variety of autoimmune
diseases such as systemic lupus erythematosus1
Clinical diagnosis should not be made on the findings of a single test result, but should integrate
both clinical and laboratory data.
PRINCIPLE OF THE METHOD
Rheumatoid factors (RF) cause agglutination of the latex particles coated with human gammaglobulin.
The agglutination of the latex particles is proportional to the RF concentration and can be measured by turbidimetry2-4
Serum collected by standard procedures.
RF in serum is stable for 7 days at 2-8°C.
A reagent blank should be done every day and a calibration at least every 2 months, after reagent
lot change or as required by quality control procedures.
Biosystems Rheumatoid Factor Reagent QUALITY CONTROL
It is recommended to use the Rheumatoid Control Serum level I (Cod. 31213) and II (Cod. 31214)
to verify the accuracy of the measurement procedure.
Each laboratory should establish its own internal Quality Control scheme and procedures for
corrective action if control results are not within the acceptable limits
Biosystems Coagulation reagents include the main diagnostic tests and they are characterized by high stability and a good performance using low volume consumption.
These reagents can be performed in semiautomatic and automatic coagulation instruments, independently of the kind of clot detection method (optical and mechanic).