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Rheumatoid Factor IgA/IgG/IgM ELISA

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Catalog no.RE70341
Regulatory Status
EU: CE
Kit size
12 x 8
Method
ELISA
Incubation time
3 x 30 min, 1 x 5 min
Standard range
0 - 300 U/mL, cut-off 15 U/mL
Specimen / Volumes
10 µL serum
Substrate / isotope
TMB 450 nm
instructions for usecertificateMSDS

The Rheumatoid Factor IgA/IgG/IgM ELISA is a solid phase enzyme immunoassay with highly purified Fc fragment of human immunoglobuline (IgG) for the separate quantitative and qualitative detection of IgG, IgM and IgA rheumatoid factors (RF) in human serum. The assay is an aid in the diagnosis of rheumatoid arthritis (RA). Rheumatoid factors (RF), first described in 1940 as antibodies reacting with gamma globulins, are autoantibodies directed against the C-terminal part of the constant region of the IgG heavy chain, the IgG Fc. Although named after the disease they were initially associated with, RFs are found both in the healthy population and several diseases. The diseases commonly associated with high RF concentrations are rheumatoid arthritis (RA; 50-90%) and Sjögren`s syndrome (75-95%). They are also found in systemic lupus erythematosus (SLE; 15-35%), systemic sclerosis (20-30%) polymyositis / dermatomyosisits (5-10%), cryoglobulinemia (40-100%) and mixed connective tissue diseases (MCTD; 50-60%). Although the presence of IgM RF in the serum has been regarded as the most important serological indicator for RA, thus included in the ACR list of criteria for the diagnosis of this disease, RF of IgG and IgA subclass are important for diagnosis as well. Determination of these isotypes provides additional information with regard to diagnosis, differential diagnosis and follow-up of RA in comparison to conventional techniques such as latex agglutination test and nephelometry. Whilst RF of subclass IgM are most sensitive for diagnosis of RA, thus most suitable for screening, RF of subclass IgG are most specific for RA and like subclass IgA correlate with clinical parameters and disease activity. The presence of all three subclasses together is 100 % specific for RA. RF in SLE are associated with sicca syndrome, hypergammaglobulinemia, high titer of anti-nuclear antibodies, anemia and usually SS-A and SS-B antibodies appearance. All three subclasses are found in SLE. Especially the subclass IgA defines a subgroup of SLE patients characterized by distinct autoimmune phenomena and high disease activity in the absence of nephritis.

For concrete data please consult the Instruction for Use in the download box on the top right side.

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Our comprehensive immunoassay portfolio includes a number of specialty diagnostic immunoassays for endocrinology, immunology and autoimmunity, as well as for diagnosis of multiple infectious diseases. We are pioneers and market leaders in saliva diagnostics, with over 40 years of experience supplying a broad portfolio of luminescence- and ELISA-based tests, including our highly acclaimed HMGB1 and MuSK-Ab ELISAs.

And as experts in laboratory automation, we can support our customers with the protocols for open ELISA platforms, such as the Freedom EVOlyzer or Thunderbolt®.

All products are only available for sale to laboratory professionals and may not be available in all countries. Availability and regulatory status may vary across regions depending on local country-specific registration. Please always read and follow the instructions for use. 

All of our assays have been designed and manufactured to meet the highest global regulatory requirements and quality standards. Tecan is certified under ISO 9001:2015, ISO 13485:2016 and is audited by a notified body according to Medical Device Single Audit Program (MDSAP).

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As part of the Tecan Group, we have a leading market position in diagnostics and research, with over 40 years of experience in the development, manufacture and supply of enzyme-, radiolabel- and luminescence-based immunoassays.

Our range of high-quality immunoassays is supported by a diverse portfolio of automated solutions, making us the perfect partner for you and your customers.

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