Bcell Design introduces its Human Fc IgM Rheumatoid Factor, a monoclonal alternative to donor-derived RF materials designed to deliver consistent performance, reliable supply and improved traceability for IVD applications.
Moving beyond donor-derived Rheumatoid Factor
Rheumatoid Factor (RF) testing plays an important role in the investigation of autoimmune diseases, particularly rheumatoid arthritis.
For IVD manufacturers and diagnostic laboratories, however, the biological materials used as controls and calibrators can present significant challenges.
Donor-derived RF sera and plasma are inherently dependent on human samples. This can result in lot-to-lot variability, limited availability and additional validation and documentation requirements.
Bcell Design offers a different approach.
Our Human Fc IgM Rheumatoid Factor is a pentameric monoclonal IgM with a full human Fc region, designed to replicate native RF structural behavior across different assay formats.
Consistency, batch after batch
Produced through Bcell Design’s hybridoma infrastructure, the Human Fc IgM Rheumatoid Factor provides a controlled and reproducible alternative to donor-derived materials.
Its RF activity is greater than 1,800 IU/mL, with demonstrated batch-to-batch consistency (CV < 5%).
This monoclonal production approach provides three key benefits:
Consistent performance
The same isotype, binding affinity and concentration profile from one batch to the next help reduce the challenges associated with lot variability.
Reliable availability
Production is independent of human donation, reducing the risk of rare-donor bottlenecks and supply shortages.
Improved traceability
A fixed molecular definition across batches supports robust documentation and helps address the traceability requirements faced by IVD manufacturers.
Validated across major diagnostic platforms
The Human Fc IgM Rheumatoid Factor has been evaluated for use in nephelometric, turbidimetric and ELISA-based assay formats.
Its performance has also been validated on major diagnostic platforms including Abbott Alinity, Roche cobas and Beckman DxC.
If your platform is not listed, our team can discuss compatibility testing for your specific application.
Test it in your own application
For IVD manufacturers currently using donor-derived RF sera, Bcell Design’s Human Fc IgM Rheumatoid Factor offers an opportunity to evaluate a more standardized and reproducible alternative.
A free sample is available for compatibility testing. Simply share your platform and application with our team and we will help you identify the appropriate testing conditions.
For a deeper look at RF testing, the limitations of plasma-based materials and the specifications of our monoclonal solution, you can also access our dedicated technical white paper.
Ready to evaluate a monoclonal alternative to donor-derived Rheumatoid Factor?