| The presence of IgM Rheumatoid Factor (RF) in the
serum is the sole serological indicator included in the
ACR list of criteria for the diagnosis of RA. RFs are a
subset of antiglobulins directed against the Fc region
of IgG. The here presented test systems for the determination
of rheumatoid factors use only human Fcfragments
as coated antigen. The Rheumatoid Factor
Screen assay is designed to simultaneously screen for
IgG/IgM/IgA rheumatoid factors. Further differentiation
and typing should be carried out by using the
individual test kits for the detection of IgG, IgM and
IgA autoantibodies. |
|
|
 |
 |
|
| Tests |
12 x 8 Tests |
|
|
|
|
| Calculation |
quantitative |
|
|
|
|
| Range |
Screen: 0 – 500 U/ml
IgG: 0 – 500 U/ml
IgM: 0 – 500 IU/ml
IgA: 0 – 500 U/ml |
|
|
|
|
| Cut-off |
Screen: 25 U/ml
IgG: 20 U/ml
IgM: 20 IU/ml
IgA: 20 U/ml |
|
|
|
|
| Sensitivity |
each: 1 U/ml and 1 IU/ml, resp. |
|
|
|
|
| Calibration |
WHO 64/2 |
|
|
|
|
| Substrate |
TMB / 450 nm |
|
|
|
Instruction for Use: ORG 522S-0508-01-gb.pdf
Material-Safety-Datasheet: ORG 522A-msds-v2.pdf