Tysabri (natalizumab) is a humanized, recombinant monoclonal antibody that binds to the α4-subunits of α4ß1 and α4ß7 integrin on mononuclear blood cells and can block their binding to the adhesion molecule VCAM-1 among others on endothelial cells. The important effect of this blockage in multiple sclerosis (MS) patients is that inflammatory mononuclear cells in less degree enter the central nervous system.
Antibodies against Tysabri in the blood may block its binding to the integrin. Demonstration of the antibodies has a great importance for the validation of the effects of Tysabri on MS patients.
The validation of the beneficial effects of Tysabri on the MS patient is perform by use of an ELISA-assay (developed and validated by Biogen Idec Inc.) analysis of serum patient samples.
The results are given as positive or negative for the presence of antibodies to Tysabri. The interpretation of a positive sample is that the measured antibodies in the sample are of clinical relevance (Biogen Idec).
Samples are analysed in Neuroimmunology Laboratory every 2. weeks. The analysis results are sent to LABKAII/sundhedsplatform for hospitals in Region H and by ordinary mail to other hospitals as soon as possible after analysis. The result of the analysis is sent out as soon as possible and at most within 3 weeks after receiving the sample.
617 d.kr. (83 €)