Intended use:
RIDASCREEN® IFX Monitoring is an enzyme linked immunoassay intended for the quantitative determination of infliximab (IFX, Remicade®, anti-TNFα) and its biosimilars Remsima®, Inflectra® and Flixabi® in human serum and plasma.
Key features of RIDASCREEN® IFX Monitoring:
- validated in clinical trials
- highly specific monoclonal antibody MA-IFX6B7, which has also been used in the TAXIT-study (KU Leuven)
- equally well suited for TDM of Remicade®, Inflectra®, and Remsima®
- 2 controls at the decision sites (3 and 7 µg/ml IFX)
- breakable microwell plate
- validated for automated 4-Plate-ELISA-Reader (e.g. DSX).
* KU Leuven (Belgium) was conducting the Taxit study which demonstrated the positive effect of therapeutic drug monitoring (TDM) of Infliximab (IFX) in regards to cost saving and therapy optimization. They are world leaders in drug monitoring..
Individual dose adjustment by measuring drug levels
Due to individual pharmacokinetics, different people show different drug levels in the blood even though they receive identical IFX dosage. However, a certain drug concentration in the patient’s blood must be present to be effective. By therapeutic drug monitoring of infliximab this can be checked and the dosage can be optimally adjusted to the needs of the patient.
For this purpose, the IFX drug concentrations in the blood are tested before the next infusion. In addition to the therapeutic benefits, TDM of infliximab helps reducing the cost of treatment.
| Result TDM of infliximab | Therapy optimization / action |
|---|---|
| Low bioavailability of IFX in the blood | Increase dosage or decrease infusion interval |
| Bioavailability of IFX in the blood too high | Reduction of dosage or increase infusion interval |
| Adequate bioavailability but lack of response of patient to the treatment | Switch to alternative form of treatment |
Single Components:
| Art. No. | G09041 |
|---|---|
| Test format | Microtiterplate with 96 wells (12 strips with 8 breakable wells each) |
| Standard range | 6 Standards (0 / 5 / 10 / 20 / 60 / 120 ng/ml) |
| Incubation time | approx. 2 h 10 min |
| External link I | TDM Checker |
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.
