|Description||Tumor Necrosis Factor alpha (TNFa) belongs to the proinflammatory cytokines,
which promote and sustain inflammatory reactions. It is produced by macrophages
and T cells and plays a central role in both acute and chronic inflammations. Consequently chronic inflammatory diseases like Crohn’s disease, ulcerative colitis, rheumatoidarthritis, or psoriasis are increasingly being treated with antibodies against
TNFa, which target directly the underlying inflammatory processes.|
|Indication||The IDK monitor enzyme immunoassays are intended for the determination of Infliximab drug concentration and for the quantitative determination of total TNFa antibodies o infliximab (e.g. REMICADE®, Remsima®, Inflectra®.|
|Additional Info|| Infliximab Theraputic Drug Monitoring request comprises two tests. 1 - measurement of Infliximab drug concentration in serum (This ELISA is designed to determine the quantity of free infliximab (therapeutic antibody agains TNFa) ans 2- - determinantion of anti-drug Ab to infliximab (This ELISA serves for the determination of antibodies against TNFa-Blocker infliximab|
|Interpretation|| In 2018 a new International WHO infliximab standard (NIBSC 16/170) became available. It was identified that the existing IDKmonitor Infliximab drug level ELISA did not report the expected concentration of the WHO infliximab standard, but a 33% lower concentration. The manufacturers, Immunodiagnostik AG, have therefore recalibrated their Infliximab Drug Levels assay to generate results in relation to the new International WHO infliximab standard (NIBSC 16/170).
Therefore, when comparing the drug concentration result generated by Leeds with the Devon and Exeter result, please multiply the Devon and Exeter result by 1.5.
For example: D&E result = 3.5mg/L
3.5 x1.5 = 5.25mg/L|
|Collection Conditions|| |
|Min. Vol|| |
|Ref. Range (Male)|| |
|Ref. Range (Female)|| |
|Ref. Range (Paed)|| |
|Ref. Range Notes|| Infliximab total anti-drug antibody (ADA): Cutoff = 10 AU/ml. No reference range currently established for Inliximab drug level.|
|Units|| - Not Defined -|
|IP Acute TAT||2 weeks|
|IP Routine TAT||2 weeks|
|GP Acute TAT||- Not Defined -|
|GP Routine TAT||- Not Defined -|
Originally edited by : Anna McHugh. Review due on 27/02/2020 12:35:32. Published By Anna McHugh on 27/02/2019 12:35:32.