Enzyme immunoassay for the semi-quantitative determination (screening) of total antibodies to infliximab biosimilar (Remsima®) in serum and plasma

SHIKARI® Semi-Quantitative Free/Total Antibodies to Infliximab Biosimilar ELISA is a sandwich assay for the determination of total and free antibodies against infliximab in serum and plasma samples. During the first incubation period, the separation of infliximab specific antibody-infliximab immune complex is provided by adding dissociation buffer. After transferring dissociation mix to the plate, infliximab antibodies are separated from infliximab in patient serum/plasma samples and they are captured by the drug infliximab coated on the wall of the microtiter wells and horse radish peroxidase (HRP) conjugated probe. After washing away the unbound components from samples, the bound enzymatic activity is detected by addition of tetramethylbenzidine (TMB) chromogen substrate. Finally, the reaction is terminated with an acidic stop solution. The intensity of the reaction colour is directly proportional to the concentration of infliximab antibodies in sample.

This kit can be also used as a semi-quantitative test for free anti-drug antibodies determination without dissociation and neutralization steps.

Remsima®, the world first biosimilar mAb (approved in 2013 by EMA). In this context, demonstration of anti-infliximab antibodies during treatment with infliximab (Remsima®) has a major concern and monitoring for the presence and/or quantitation of specific antibodies during clinical trials is an important issue for follow up of the treatment regimens. With the SHIKARI® S-AIR ELISA Kit infiliximab-specific antibodies that are bound to infiliximab in serum and can not be detected by free antibody detection kits can be determined in patients receiving Remsima®.

All SHIKARI® ELISA kits are suitable for biosimilar work.All SHIKARI® ELISA kits are produced under ISO 13485 quality system and have CE IVD mark.

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