Intended use:
RIDASCREEN® GLM Monitoring is an enzyme linked immunoassay intended for the quantitative determination of golimumab (GLM, Simponi®) in human serum and plasma.
General information:
Golimumab (GLM) is a human monoclonal antibody and binds to both the soluble and transmembrane bioactive forms of human TNF-alpha, giving rise to stable high-affinity complexes thereby preventing the binding of TNF-alpha to its receptors. Golimumab has been approved for the treatment of various chronic immune-mediated inflammatory disorders in which TNF-alpha plays an important role, including rheumatoid arthritis (RA), psoriatic arthritis, ankylosing spondylitis and ulcerative colitis (UC). Recent data on TDM have shown a positive relation between GLM trough serum concentrations and clinical outcomes in patients with RA3 and UC4. TDM may therefore be very instrumental to optimize treatment.
RIDASCREEN® GLM Monitoring uses a highly specific monoclonal antibody (MA-GOM171D8), which was isolated and characterized at the KU Leuven. It detects only golimumab; other anti-TNF drugs (like infliximab, adalimumab) do not interfere with the measurement.
Key features:
- CE-marked version of the ELISA tests of KU Leuven
- Highly specific antibodies
- Ready to use reagents
- Validated for use on automated ELISA systems, e.g. the Dynex DSX®
Single Components:
| Art. No. | G09047 |
|---|---|
| Test format | Microtiterplate with 96 wells (12 strips with 8 breakable wells each) |
| Incubation time | 1 h 40 min |
Dear customers,
we have started to provide the documents for our products in an electronic format. These are the Instructions for Use (IFU), the Safety Data Sheets (SDS) and the Certificate of Analysis (CoA). For batches placed on the market after 01 January 2023, you can find our documents on the eIFU portal eifu.r-biopharm.com.
