Intended use:
For in vitro diagnostic use. RIDASCREEN® ADM Monitoring is an enzyme immunoassay for the quantitative determination of adalimumab (ADM, Humira®) in human serum and plasma.
Therapeutic Drug Monitoring
Adalimumab (ADM) is a fully human antibody that targets the pro-inflammatory cytokine TNF-alpha and is used to treat chronic inflammatory diseases like inflammatory bowel disease, rheumatoid arthritis, spondyloarthritis and plaque psoriasis. It has been shown that adalimumab can induce deep remission and improve the patient’s quality of life. Some patients do not respond to ADM therapy upon induction (primary non-responders), while others lose response over time (secondary non-responders). A drug can only exert its pharmacologic effect when adequate concentrations are achieved in the circulation. The serum concentration of adalimumab just before the next injection, defined as the trough concentration, has been used for therapeutic drug monitoring (TDM).
Recent data on TDM have shown that a good clinical response is associated with adequate trough concentrations in inflammatory bowel disease and rheumatoid arthritis patients. TDM may therefore be very instrumental to optimize treatment and to overcome secondary loss of response.
The RIDASCREEN® ADM Monitoring uses a highly specific monoclonal antibody (MA-ADM40D8, isolated and characterized at the KU Leuven) anti-TNF such as infliximab and golimumab do not interfere with the measurement. As an example of TDM, the use of adalimumab trough concentration measurements in inflammatory bowel disease patients is described.
Key features:
- CE-marked versions of the ELISA tests of KU Leuven
- Highly specific antibodies
- Validated in clinical trials
- Validated on automated ELISA readers (e.g. DSX®)
Single Components:
| Art. No. | G09043 |
|---|---|
| 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/clinic.
